我们决定向甘孜泸定、雅安石棉捐赠300万元现金、300万元物资，目前已成功对接甘孜州红十字会、雅安市红十字会，今天下午已经完成打款，物资根据当地所需正在紧急集结。对于灾区需要的其他支持，我们也当全力以赴。”
9月6日下午，四川科伦药业股份有限公司相关负责人告诉记者，针对四川泸定6.8级地震中受灾严重的泸定县和石棉县，他们紧急启动灾害应急处理方案，并进行现金和物资捐赠。
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2026-02-06
Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) ...
MoreCHENGDU, China, February 4, 2026—Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that a new indication application for its TROP2-directed ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been approved by the National Medical Products Administration (NMPA) of China for treatment of adult patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer (BC) who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting. This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China.
The approval is based on the positive results from the Phase III OptiTROP-Breast02 study which was selected as a Late-Breaking Abstract (LBA) and presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) Congress.
The OptiTROP-Breast02 study evaluated the efficacy and safety of sac-TMT monotherapy compared to investigator's choice of chemotherapy in patients with unresectable or metastatic HR+/HER2- BC. Of the patients enrolled in this Phase III study, 95.7% had visceral metastases, 75.9% had liver metastases; 52.9% were HER2-zero (IHC 0), while 47.1% were HER2-low (IHC 1+ or IHC 2+/ISH-). All patients had received prior CDK4/6 inhibitor and taxane therapy; 56.6% had received ≥2 lines of prior chemotherapy in the advanced or metastatic setting.
Results showed that sac-TMT demonstrated a statistically significant and clinically meaningful increase in progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared to chemotherapy (8.3 vs. 4.1 months; hazard ratios (HR), 0.35; 95% CI: 0.26-0.48; p<0.0001). Consistent PFS benefits were observed across all pre-specified subgroups, including HER2-zero and HER2-low, number of chemotherapy lines received in the advanced or metastatic setting, presence of baseline visceral and liver metastases and previous CDK4/6 inhibitor use. According to BICR-assessed PFS results, the hazard ratios in the HER2-zero and HER2-low (IHC 1+ or IHC 2+/ISH-) subgroups were 0.39 (95% CI: 0.26-0.57) and 0.31 (95% CI: 0.20-0.48), respectively. A trend towards overall survival (OS) benefit and a significantly higher objective response rate (ORR) (41.5% vs. 24.1%) were also observed compared with chemotherapy. [1]
Currently, Phase III clinical studies of sac-TMT with or without pembrolizumab (KEYTRUDA®[2]) for the treatment of chemotherapy-naïve HR+/HER2- BC who have received prior ET have been initiated globally (NCT06312176) and in China (NCT07071337).
About HR+/HER2- Breast Cancer
Breast cancer is one of the most common malignant tumors that seriously threaten women's health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis. This subtype is typically sensitive to hormonal therapy, and therefore, endocrine therapy combined with a CDK4/6 inhibitor constitutes the standard treatment. However, for patients with HR+/HER2- advanced breast cancer whose disease progresses on endocrine therapy, chemotherapy is widely used in clinical while it is associated with low response rate (ORR approximately 14%-22.9%) and limited survival benefit (mPFS approximately 4.0-4.9 months).
About Sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.
Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating16 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
Reference Sources：
[1] Fan Y, Li H, Wang H, et al. ESMO Congress 2025, LBA23.
[2] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2026-01-16
Kelun-Biotech Showcases Innovative Achievements and Future Development Strategy ...
MoreCHENGDU, China, Jan. 16, 2026 /PRNewswire/ -- From January 12 to 15, 2026, the 44th J.P. Morgan Healthcare Conference (JPMHC) was held in San Francisco, California, USA. Dr. Ge Michael, President and CEO of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK), was invited to attend the conference and delivered a keynote speech on the morning of January 15 (local time) and presented the Company's latest achievements in drug R&D, commercialization, and globalization, and outlined its innovation strategy and future development plans.
Since initiating its innovation journey in 2012, Kelun-Biotech has rapidly emerged as a leader in China's innovative drug field, building differentiated technology platforms and robust R&D pipelines. Leveraging its global leading OptiDC™ platform for antibody-drug conjugates (ADCs) and novel drug conjugates (DCs), the Company continuously advances the differentiated development of ADCs and novel DCs, forming a gradient portfolio for treating multiple tumor types. Currently, Kelun-Biotech has two ADC products on market: sacituzumab tirumotecan (sac-TMT, 佳泰莱®) and trastuzumab botidotin (舒泰莱®), covering breast cancer and lung cancer indications. Additionally, nine uniquely designed ADC and novel DC drugs—including cutting-edge directions such as bispecific ADC and radiopharmaceutical conjugate (RDC) are in clinical stage. For high-incidence tumor types in China, such as breast cancer, lung cancer, and gastrointestinal tumors, the Company has initiated nine pivotal studies, while multiple Phase II clinical studies targeting gynecological tumors are progressing steadily. Furthermore, Kelun-Biotech has also developed several non-DC candidates and expanded indications into non-oncology areas.
Over the past year, Kelun-Biotech has presented multiple research findings at international academic conferences and published in authoritative journals: three were selected for oral presentations at the American Society of Clinical Oncology (ASCO) annual meeting, and three were selected as Late-Breaking Abstracts (LBA) for oral presentations at the European Society for Medical Oncology (ESMO) Congress. Among these, the results of the OptiTROP-Lung04 study of sac-TMT for treating EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) after TKI therapy were presented at the Presidential Symposium session of ESMO and simultaneously published in The New England Journal of Medicine, highlighting its global academic and clinical value.
In terms of commercialization, Kelun-Biotech has formed a competitive initial product portfolio. Its core product, the TROP2-directed ADC sac-TMT, has been approved in China for three indications: second-line and above triple-negative breast cancer, second-line and third-line EGFR-mutated NSCLC. The HER2-directed ADC trastuzumab botidotin was approved last year for second-line and above HER2-positive breast cancer, becoming the first domestically developed HER2-directed ADC approved for this indication. Furthermore, the anti-EGFR monoclonal antibody Cetuximab N01 (达泰莱®) for RAS wild-type colorectal cancer and the anti-PD-L1 monoclonal antibody tagitanlimab (科泰莱®) for nasopharyngeal carcinoma have been launched. Another small-molecule RET inhibitor A400 is expected to be approved within the year, bringing the total number of commercialized products in China to five. Currently, three of the Company's commercialized products, covering five indications, have been included in the National Reimbursement Drug List (NRDL), further benefiting a broad population of cancer patients.
While strengthening its presence in the domestic market, Kelun-Biotech is actively expanding overseas. It has established collaborations with MSD, Ellipses, Windward Bio and Crescent Biopharma to maximize the value of its pipeline value and corporate worth. Among these, MSD is evaluating 16 global Phase III clinical studies of sac-TMT.
The breakthroughs in both clinical development and commercialization are driven by the Company's sustained investment in innovative R&D. With over a decade of accumulation in the ADC field, Kelun-Biotech's proprietary OptiDC™ platform enables differentiated design of drug candidates, which combines specific targets or targeting mechanisms with the most suitable payload-linker strategy to balance efficacy and safety. Additionally, the company is adopting a "multi-pronged" innovation strategy to continuously enhance platform capabilities. By exploring novel targets, new payloads, and diverse conjugation technologies, it is expanding the application boundaries across both oncology and non-oncology fields.
Looking ahead, Kelun-Biotech will consolidate its foundations in R&D, technologies, platforms, and operations by Ｅxecuting five key development strategies. Concurrently, the Company will elevate its globalization strategy, enhancing its capabilities in product development, registration, and commercialization in ex-China market, advancing on its path to becoming a world-class biopharmaceutical company.
Please refer to the "Investor Relations-Investor Calendar" page of the company's official website for the presentation materials. You can visit the website for further details.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-07
Kelun-Biotech to Attend the 44th J.P. Morgan Healthcare Conference, Sharing Its ...
MoreThe 44th J.P. Morgan Healthcare Conference (JPMHC) will be held in San Francisco, California, USA, from January 12 to 15, 2026. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) has been invited to attend the conference and Dr. Michael Ge, President and CEO of Kelun-Biotech, will share the company’s latest business progresses as well as its innovation capabilities and strategies.
Presentation Time: Thursday, January 15, 2026 at 9:30 AM Pacific Standard Time
Presentation Venue: Westin St. Francis, San Francisco, USA
J.P. Morgan Annual Healthcare Conference is honored as a “benchmark for development and investment in the global healthcare area”. During the conference, Kelun-Biotech will join massive seasoned experts and industry leaders to discuss cutting-edge trends in biopharmaceutical innovation. Based on the ongoing transformation moment of the global pharmaceutical industry, the company will actively pursue mutually beneficial partnership opportunities on the international stage.
You can visit “Investor Relations - Investor Calendar” page of Kelun-Biotech’s official website for participation of live webcast of presentation session, and watch replay within 30 days after the conference.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-05
Kelun-Biotech Receives Investigational New Drug Approval for ITGB6-Targeted ADC ...
MoreCHENGDU, China, Jan. 5, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that its Investigational New Drug (IND) application for SKB105 (also known as CR-003), an internally developed integrin beta-6 (ITGB6)-targeted antibody-drug conjugate (ADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors.
In December 2025, Kelun-Biotech and Crescent Biopharma, Inc. ("Crescent") entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD-1 x VEGF bispecific antibody, also known as CR-001). Under the collaboration, Kelun-Biotech granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In addition, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China. The IND application for SKB118/CR-001 has been cleared by the U.S. Food and Drug Administration (FDA) with a global Phase I/II clinical trial for the treatment of advanced solid tumors is set to commence shortly. Kelun-Biotech plans to submit an IND application for SKB118/CR-001 to the Center for Drug Evaluation of the National Medical Products Administration of China in the near future.
About SKB105 (also known as CR-003)
SKB105 is a differentiated ADC targeting ITGB6 with a topoisomerase I inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 incorporates proprietary Kthiol® irreversible conjugation technology, linking an anti-ITGB6 fully human Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) to a clinically validated cleavable linker. This design aims to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile.
About SKB118(also known as CR-001)
SKB118/CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, SKB118/CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118/CR-001's anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, particularly in conjunction with ADCs.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
2026-01-05
Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sa...
MoreCHENGDU, China, January 5, 2026 -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company,” 6990.HK) today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) in combination with MSD’s anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[1]) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and ALK-negative.
BTD is granted for treatment regimens that provide effective treatment or prevention for conditions with no currently available therapy, or that demonstrate significant clinical advantages over currently available treatments. For drugs included in the breakthrough therapy process, if relevant conditions are met, applications for conditional approval and priority review and approval can be submitted when applying for marketing authorization.
Previously, the company announced that results from the Phase III clinical trial of OptiTROP-Lung05, evaluating sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC, demonstrated a statistically significant and clinically meaningful improvement in its primary endpoint of progression-free survival (PFS). A positive trend was also observed in overall survival (OS). OptiTROP-Lung05 is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in the first-line treatment of NSCLC. Granting of BTD for the first-line treatment of PD-L1-positive NSCLC indication offers pathways to expedite the review and potential approval process of sac-TMT for this indication.
To date, sac-TMT has received five BTDs for:
locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
locally advanced or metastatic EGFR-mutant NSCLC after progression on EGFR-TKI therapy in January 2023;
locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023;
first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024;
In combination with anti-PD-L1 monoclonal antibody tagitanlimab for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations in June 2025.
About sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
To date, three indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; Unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of cancer patients.
Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration, and was included in the priority review and approval process.
As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
[1] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2025-12-04
Kelun-Biotech and Crescent Biopharma Announce Strategic Partnership to Develop a...
MoreCompanies to advance CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed antibody-drug conjugate (ADC), in global markets and China
Collaboration designed to accelerate and expand the development of synergistic combinations with CR-001 and ADCs, including SKB105
CR-001 and SKB105 on track to enter Phase 1/2 monotherapy clinical trials in Q1 2026 with combination studies to follow
CHENGDU, China and WALTHAM, Mass., Dec. 4, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs, and Crescent Biopharma, Inc. ("Crescent") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, today announced that the companies have entered into a strategic partnership to develop and commercialize oncology therapeutics, including novel combinations.
The partnership involves Crescent's CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech's SKB105, an integrin beta-6 (ITGB6)-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Both candidates are being developed for the treatment of solid tumors and are expected to enter Phase 1/2 monotherapy clinical trials in the first quarter of 2026.
Under the terms of the collaboration, Crescent has granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China (including mainland China, Hong Kong, Macau and Taiwan). In addition, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 in the United States, Europe and all other markets outside of Greater China. The partnership includes the development of these candidates as monotherapies, and also the evaluation of CR-001 in combination with SKB105.Both Crescent and Kelun-Biotech have the right to independently develop CR-001 in additional combinations, including combinations of CR-001 with proprietary ADC pipeline assets.
Dr. Michael Ge, chief Ｅxecutive officer of Kelun-Biotech, said, "We are pleased to have entered into a partnership with Crescent for two innovative assets, CR-001 and SKB105. This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 in the global market, bolstering its potential commercial value and our global collaboration network. Our creative global partnership combines the capabilities of both companies to explore novel monotherapies and combination strategies for tumor treatments with SKB105 and CR-001. By leveraging China's abundant clinical resources and Ｅxecution efficiency, we aim to expedite clinical development while rigorously maintaining the highest global standards. We believe this partnership creates a powerful synergy to maximize the potential of these two drug candidates for the treatment of patients in both China and the rest of the world."
"We are thrilled to be partnering with Kelun-Biotech, an established leader in the development and commercialization of ADCs who shares our commitment to bringing next generation therapeutics that can improve outcomes for people living with cancer," said Joshua Brumm, chief Ｅxecutive officer of Crescent. "This collaboration expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001, which has the potential to be a foundational backbone therapy. We look forward to working with Kelun-Biotech to drive innovative therapeutics with the potential to address multiple tumor types and transform cancer care."
Under the collaboration, Kelun-Biotech will receive an upfront payment of US$80 million from Crescent and is also eligible to receive additional milestones of up to US$1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105. Kelun-Biotech is also eligible to receive additional payment from Crescent if Crescent undergoes a near-term change of control or enters into a sublicense agreement with a third party. Crescent will receive an upfront payment of US$20 million from Kelun-Biotech and is also eligible to receive additional milestones of up to US$30 million, plus tiered low to middle single digit royalties on net sales of CR-001.
About CR-001 (also known as SKB118)
CR-001 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended for reducing blood supply to tumor cells and inhibiting tumor growth. In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. CR-001's anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as the administration of CR-001 with antibody-drug conjugates (ADCs). A global Phase 1/2 trial of CR-001 in patients with solid tumors is anticipated to commence in the first quarter of 2026.
About SKB105 (also known as CR-003)
SKB105 is a differentiated ADC targeting integrin beta-6 (ITGB6) with a topoisomerase 1 inhibitor payload. ITGB6 is overexpressed in many solid tumors, but shows minimal to no expression in most normal tissues, thereby potentially reducing the risk of systemic toxicity and off-target effects. SKB105 consists of an anti-ITGB6 fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. The molecule incorporates proprietary Kthiol® irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic (PK) profile in preclinical models. A Phase 1/2 clinical trial of SKB105 in patients with solid tumors is anticipated to commence in the first quarter of 2026.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.
About Crescent Biopharma
Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. Crescent 's pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates (ADCs). By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow Crescent on LinkedIn and X.
2025-10-20
The New England Journal of Medicine Publishes Results of Phase III OptiTROP-Lung...
MoreAfter a median follow-up of 18.9 months, the median PFS was 8.3 months in the sac-TMT group and 4.3 months in the chemotherapy group (hazard ratio (HR), 0.49; 95% confidence interval (CI), 0.39 to 0.62; two-sided P<0.0001).
OS was significantly longer with sac-TMT than with chemotherapy (HR, 0.60; 95% CI, 0.44 to 0.82; two-sided P=0.001); 18-month OS rate was 65.8% and 48.0%, respectively. In the supplementary analysis, in which data were censored at the start date of subsequent ADC, the HR was 0.56 (95% CI, 0.41 to 0.77).
Sac-TMT was associated with a higher incidence of stomatitis with most cases being mild and with grade 3 or higher cases reported in very few patients (4.8%; all were grade 3). Low incidence of ocular-surface toxic effects, no ILD or pneumonitis, and one infusion-related reaction (grade 2) was reported in the sac-TMT group.
On October 20, results from the Phase III registrational clinical study OptiTROP-Lung04—led by Professor Zhang Li's team from Sun Yat-sen University Cancer Center—were published in the New England Journal of Medicine (Impact Factor = 78.5). The study evaluated the efficacy and safety of the TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy. The study was also selected as a Late-Breaking Abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) Congress and was presented as an oral report in the Presidential Symposium (Presentation # LBA5).
OptiTROP-Lung04 is a randomized, open-label, multicenter Phase III study designed to evaluate the efficacy and safety of sac-TMT monotherapy versus pemetrexed plus platinum in patients with EGFR-mutated locally advanced or metastatic NSCLC who had progressed on prior EGFR-TKI therapy. Eligible patients were those with histologically and/or cytologically confirmed disease. The primary endpoint was Progression-Free Survival (PFS) assessed by a Blinded Independent Review Committee (BIRC) per RECIST v1.1, and the key secondary endpoint was overall survival (OS). Results showed that compared with platinum-based doublet chemotherapy, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS. Consistent PFS and OS benefits were observed across all prespecified subgroups, including prior EGFR-TKI therapy, presence of liver or brain metastases, and EGFR mutation subtype.
Based on the positive results of the OptiTROP-Lung04 study, sac-TMT has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI therapy. To date, sac-TMT monotherapy remains the only approved treatment option for advanced EGFR-mutant NSCLC patients who have progressed after prior TKI therapy, as well as those who have progressed after prior TKI and platinum-based chemotherapy (either concurrently or sequentially). This achievement provides comprehensive coverage for the entire population of TKI-resistant patients.
Dr. Michael Ge, Chief Ｅxecutive Officer of Kelun-Biotech, commented: “OptiTROP-Lung04 is a key study that propels sac-TMT from late-line to an earlier-line treatment-setting in lung cancer, achieving a significant improvement in overall survival. We are thrilled that the results have been published in The New England Journal of Medicine, allowing this important finding to be shared widely among medical professionals and providing a reference for future lung cancer research. Together with our partner MSD, we will continue to advance sac-TMT’s clinical development and regulatory approvals, covering broader lung cancer and other indications, with the goal of making sac-TMT a cornerstone therapy for the benefit of patients.”
Professor Shengxiang Ren from the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University, stated: “The application of third-generation EGFR-TKIs has significantly improved the overall prognosis for patients with advanced EGFR-mutant NSCLC. However, drug resistance is almost inevitable. Traditional treatment after resistance involves platinum-based doublet chemotherapy, which offers limited overall benefit. In recent years, regimens of chemotherapy plus immune checkpoint inhibitors+anti-angiogenic agents, or EGFR/c-Met bsAb, or PD-1/VEGF bsAb, have been successively approved for this indication. However, all these approaches are chemotherapy-based, highlighting an urgent need to explore novel treatment regimens. The OptiTROP-Lung04 study confirms sac-TMT as the first treatment option as a monotherapy to deliver clear dual benefits in both PFS and OS following EGFR-TKI progression. The sequential application of sac-TMT prior to chemotherapy demonstrates strong competence, establishing itself as a new standard of care for patients with advanced EGFR-mutant lung cancer after TKI resistance.”
About Sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).
To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation of the NMPA, and was included in the priority review and approval process.
As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase Ⅲ global clinical studies of sac-TMT as a monotherapy or with pembrolizumab1 or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.
About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
References:
1. Pembrolizumab (KEYTRUDA®) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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2025-01-21
Kelun-Biotech’s Novel ADC Drug SKB445 Receives NMPA Approval For the treatment of advanced solid tumors
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Jan. 21, 2025.
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company has received a clinical trial notice approving the investigational new drug application for the innovative drug SKB445 developed by the Company from the Center for Drug Evaluation of the National Medical Products Administration.
SKB445 is a novel ADC drug with proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the OptiDCTM platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-01-17
Kelun-Biotech Will Attend The 43rd Annual JPM Healthcare Conference
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The 43rd J.P. Morgan Annual Healthcare Conference (“JPMHC”) 2025 will take place January 13-16 in San Fracisco, USA, local time. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or “The Company”, 6990.HK) was invited to the conference. Dr. Michael Ge, President and CEO of Kelun-Biotech, will deliver a presentation on updated business progresses and development plan of Kelun-Biotech.
Presentation Time: Pacific Time (PT) Thursday 9:30 AM, January 16, 2025
Presentation Location: San Fracisco, USA (Westin St. Francis)
JPMHC is honored as the “benchmark for the development and investment of global healthcare area”. This conference would attract more than 400 healthcare companies and 3,000 industrial investors globally for discussion of the new trends and development directions of the healthcare industry. During this JPMHC, Kelun-biotech would work together with those massive senior experts and talents of healthcare area, by focusing on the cutting-edge industrial topics, to discuss the future development and collaboration opportunities of healthcare industry.
You can visit Investor Relations page of Kelun-Biotech’s official website for participation of live webcast of presentation session, and watch replay within 30 days after the conference
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2025-01-10
Kelun-Biotech Announce Exclusive License Agreement For SKB378/HBM9378, an Anti-thymic Stromal Lymphopoietin (TSLP) Monoclonal Antibody(mAb).
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Jan. 10. 2025
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company and HBM Holdings Limited (“Harbour BioMed”) (together with the Company, the “Licensors”), have entered into an exclusive license agreement (the “License Agreement”) with Windward Bio AG (“Windward Bio”) for SKB378/HBM9378[1], an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) jointly developed by the Licensors.
Subject to the terms and conditions of the License Agreement, Windward Bio is granted an exclusive license for the research, development, manufacturing and commercialization of SKB378/HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In return, the Licensors are eligible to receive a total of up to US$970 million upfront and milestone payments as well as single to double-digit tiered royalties on net sales of SKB378/HBM9378. The US$45 million upfront and near-term payments include both cash consideration and equity in the parent company of Windward Bio. Subject to the terms and conditions of the License Agreement, the Licensors are also eligible to receive additional payment from Windward Bio if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. The payments to be made by Windward Bio to the Licensors under the License Agreement shall be paid in equal amounts to the Company and Harbour BioMed.
Windward Bio is a clinical-stage, drug development company committed to improving outcomes for people living with advanced immunological conditions with an initial focus on severe respiratory conditions. It is led by a highly experienced team of biopharmaceutical Ｅxecutives with deep discovery, development, and commercialization expertise, and is advancing a potential best-in-class TSLP monoclonal antibody into phase 2 development and creating novel, long-acting bispecific programs for immunological diseases. Collectively, they have contributed to more than 15 product launches and Ｅxecuted two Nasdaq IPOs and two sales.
In connection with the License Agreement, Windward Bio announced a US$200 million Series A financing round led by OrbiMed, Novo Holdings and Blue Owl Healthcare Opportunities with the co-investment of SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners.
Dr. Micheal Ge, CEO of Kelun-Biotech said, “We are pleased to have entered into a partnership with Windward Bio for the SKB378/HBM9378, one of our pioneering pipelines in immunology area, which is not only a proof of its potential market value globally, but also a practice of our active exploration of global cooperation. SKB378/HBM9378 is our first immunology product candidate out licensed with a NewCo model. In the future, we will continue to expand our global presence and strategic partnerships to maximize the value of our pipelines.”
ABOUT SKB378/HBM9378
SKB378/HBM9378 is a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights. SKB378/HBM9378 is a novel, recombinant fully human monoclonal antibody (mAb) that potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. This is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. SKB378/HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.
In November 2024, an IND application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) was submitted for SKB378/HBM9378 for the treatment of chronic obstructive pulmonary disease (COPD). The Company has also completed phase 1 clinical trial in healthy subjects in China under IND approval from the NMPA for the treatment of moderate-to-severe asthma.
ABOUT KELUN-BIOTECH
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visithttps://kelun-biotech.com/.
2025-01-03
Kelun-Biotech's Anti-PD-L1 (Tagitanlima）Receives NMPA Approval for Marketing
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Dec. 31. Chengdu
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world's first PD-L1 monoclonal antibody approved for the treatment of NPC.
The approval is based on a single-arm, multi-center, phase II clinical study in patients with recurrent or metastatic NPC who have failed after prior 2L+ systematic therapies, led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator, to evaluate the efficacy and safety profile of tagitanlimab monotherapy. As of the data cutoff date, the median follow-up time was 21.7 months, 132 patients entered full analysis set (FAS) totally, the independent review committee (IRC)-assessed objective recovery rate (ORR) was 26.5%, the duration of recovery (DoR) was 12.4 months and the median overall survival (OS) was 16.2 months. Meanwhile, tagitanlimab showed a manageable safety profile, where the incidence of grade 3 immune-related adverse event (irAEs) was 3.9% and no grade 3 above irAE was observed. Data from these clinical studies have been published in The Lancet Regional Health-Western Pacific[1].
Dr. Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the significant moment of the successful approval of tagitanlimab for the domestic market, which is yet another proof of Kelun-Biotech's excellence in the field of innovative drug discovery and development. The excellent efficacy and safety results achieved by tagitanlimab mark a significant progress and breakthrough in our exploration of the frontiers of medical science and technology. At the same time, we are also actively advancing our multi-strategy clinical development blueprint, aiming to deeply explore the potential of tagitanlimab in combination with ADC assets as an early-line treatment and maximize the clinical value of our oncology pipeline, with a view to reaching a wider group of patients and providing highly effective and safe therapeutic options for Chinese patients”
About NPC
The 2022 GLOBOCAN data showed that there were more than 120,000 new cases of nasopharyngeal cancer globally[2], 51,000 new cases of nasopharyngeal cancer and 28,400 deaths in China [3]. According to the 2021 CSCO guidelines, the 1L treatment regimen for non-locally treatable recurrent or metastatic nasopharyngeal cancer is based on platinum-containing combination chemotherapy, and the 2L treatment is based on monotherapy. The 5-year survival rate of patients with recurrent or metastatic nasopharyngeal cancer is 18.5%, with a median OS of 22.1 months[4], and there is still an unmet clinical need to improve the clinical benefit of this group of patients, especially those who develop metastases after treatment. In recent years, immunotherapy has provided more therapeutic options for tumor patients and has become an effective way to treat patients with nasopharyngeal carcinoma.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
Reference
[1]. Shi, Yuankai, et al. Lancet Reg Health West Pac. 2022 0ct 10:31:100617.
[2]. GLOBOCAN (2022).WHO, Global Cancer Observatory.
[3]. Journal of the National Cancer Center 4(2024)47-53.
[4].Hong S, Huang Y, Yang Y, et al. (2020)] GEM20110714: Final overall survival results of the phase III study of firstline gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma.
2024-12-04
Kelun-Biotech’s ADC Innovator SKB500 for Advanced Solid Tumors Receives A Clinical Trial Notice
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On Dec.4, the innovative drug SKB500 developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) received a clinical trial notice approving the investigational new drug application from the Center for Drug Evaluation of the National Medical Products Administration (NMPA).
SKB500 is a novel ADC drug with proprietary intellectual property rights developed by the Company based on the biological characteristics of the target and using the technology of the OptiDCTM platform, which has demonstrated promising efficacy and safety window in preclinical studies and is intended to be used for the treatment of advanced solid tumors.
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 1 project has been approved for marketing, 3 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
2024-11-27
Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT, 佳泰莱®) Approved For Marketing By NMPA Of China For 2L+ Advanced or Metastatic TNBC
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Nov.27, Chengdu
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the first domestically developed trophoblast cell-surface antigen 2 (TROP2)-directed antibody–drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) (佳泰莱®) for adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China.
The approval is based on the positive results from a randomized, controlled, phase 3 OptiTROP-Breast01 study in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). Sac-TMT demonstrated statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The results were presented at the special clinical science symposium for next-generation ADCs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2024.
Previously, NMPA has accepted two supplemental new drug applications (sNDA) seeking the approvals of sac-TMT monotherapy for the treatment of patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) following progression on EGFR-TKI therapy only, or both EGFR-TKI and platinum-based chemotherapy, respectively.
Dr. Micheal Ge, CEO of Kelun-Biotech said, “It is a great pleasure to share with you the important milestone moment of the successful approval and launch of sacituzumab tirumotecan (佳泰莱®) in China, which is a significant achievement of Kelun-Biotech's years of deep-rooted source innovation. As the company's first proprietary TROP2 ADC innovative drug, the successful launch of sacituzumab tirumotecan officially opens up a new pattern for the treatment of patients with 2L+ advanced TNBC. We expect that its excellent clinical efficacy and safety results will significantly enhance the clinical benefits and improve the quality of life of patients with advanced TNBC. In the future, we will continue to explore the clinical value of sacituzumab tirumotecan in other indications, maximize the market potential of sacituzumab tirumotecan, and satisfy the clinical needs of patients nationwide.”
ABOUT MARKET VALUE
Breast cancer is a threat to women's lives and health. Among them, triple-negative breast cancer has unique biological behavioral characteristics, and is also known as the “most toxic” breast cancer. 2022 analysis of China's malignant tumor epidemiology data shows that there are 357,000 new cases of breast cancer and 75,000 deaths in Chinese women annually [1]. In the absence of effective therapeutic targets for triple-negative breast cancer, chemotherapy is the most important systemic treatment in the clinic [2], but it often has poor efficacy and high toxicity and side effects, and the prognosis is different from other subtypes of breast cancer [3], it is vital to explore more therapeutic means to improve the clinical benefit.
ABOUT sac-TMT (佳泰莱®)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
ABOUT KELUN-BIOTECH
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 1 project has been approved for marketing, 3 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.
Reference
[1].Han, Bingfeng, et al. "Cancer incidence and mortality in China, 2022." Journal of the National Cancer Center 4.1 (2024): 47-53.
[2]. [Chinese Society of Clinical Oncology (CSCO) (2024)] Guidelines for the diagnosis and treatment of breast cancer.
[3]. https://seer.cancer.gov/statfacts/html/breast-subtypes.html .
2024-10-31
Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA Accepted by NMPA, locally advanced or metastatic EGFR-mutant NSCLC
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Oct. 31 2024, the new drug application (NDA) (the “Application”) based on the positive results from the pivotal phase III OptiTROP-Lung04 study of sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) which developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in adult patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy.
OptiTROP-Lung04 is a multi-center, randomized, registrational phase III clinical study that evaluates the efficacy and safety results of sac-TMT monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR- TKI therapy. At a pre-specified interim analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent review committee (BIRC) compared with pemetrexed plus platinum chemotherapy. Sac-TMT also showed a manageable safety profile, with no unexpected safety signals identified.
The Application is the third NDA for sac-TMT that has been accepted by the NMPA. On October 25, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE.
Previously, two NDAs for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and for sac-TMT monotherapy in adult patients with locally advanced or metastatic EGFR-mutant NSCLC who experience progression following treatment with an EGFR-TKI and platinum-based chemotherapy, respectively, were accepted by the NMPA.
Sac-TMT, a core product of the Company, is a novel human trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugate (ADC) in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.
In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).
Dr. Micheal Ge, CEO of Kelun-Biotech, said, “sac-TMT (sacituzumab govitecan) has received its third NDA. In response to unmet clinical needs, the company has always adhered to the spirit of hard work inherent in Kelun, focusing on original innovation and doing practical work to develop new drugs with differentiated advantages and international potential. We believe that sac-TMT will shine in the field of oncology and contribute Chinese strength to the global health cause.”
About Kelun-Biotech
Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.
2024-09-29
Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 CSCO Congress
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From September 25th to 29th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference.
TNBC
【2024 CSCO：Oral report by Academician Binghe Xu 】
On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session.
The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator's choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients.
Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women's lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.”
NSCLC
【2024 CSCO：Oral report by Prof.Wengfeng Fang】
On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion.
Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B.
Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.”
CC
【2024 CSCO：Oral report by Pro.Jing Wang】
On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%.
Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.”
EC/OC
【2024 CSCO：Oral report by Dr.Zhuo Yang】
On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%.
40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE).
Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.”
With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030.