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CHENGDU, 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.

CHENGDU, 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/.