Newsroom

On September 11, 2023, Kelun-Biotech announced that the major product A140 solution for infusion (Cetuximab Solution for Infusion, trade name: Datalai?) was recently accepted for marketing application by the Center for Drug Evaluation of the National Medical Products Administration (acceptance number: CXSS2300075).

A140 solution for infusion is the first cetuximab solution for infusion that filed an application for marketing in China. It is intended for the treatment of metastatic colorectal cancer with wild-type RAS genes: used in combination with FOLFOX or FOLFIRI regimens for first-line treatment; and in combination with irinotecan for patients who have failed treatment containing irinotecan. At the same time, it is also intended for the treatment of head and neck squamous cell carcinoma (HNSCC): used in combination with platinum and fluorouracil chemotherapy for first-line treatment of recurrent and/or metastatic diseases; and in combination with radiotherapy for the treatment of locally advanced diseases.

This product is a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody (mAb), which inhibits the growth and survival of tumor cells expressing EGFR. The A140 solution for infusion is firstly developed in China to be filed for production in accordance with the “Guidelines for Design of Clinical Trials of Injectable Cetuximab Biosimilar (for Trial Implementation)” using the original cetuximab as a reference drug. The reference drug ctuximab (trade name: Erbitux?) was approved for import into China in 2007. The approved indications in China include metastatic colorectal cancer and HNSCC. As of 2022, the global market size of cetuximab has reached 1.73 billion US dollars, and the sales in China have reached 2.253 billion yuan. Due to reasons such as drug accessibility, the clinical demand for cetuximab has not been met. A140 solution for infusion has the same amino acid sequence and mechanism of action as cetuximab, and its proposed indications are consistent with Erbitux?. The A140 solution for infusion will provide significantly increased accessibility once the Application is approved, and will bring compliant, safe, and effective treatment options to more patients.

In recent years, due to factors such as population aging and unhealthy lifestyles caused by improved living standards (such as sedentary lifestyle, high-fat and high-protein diets, etc.), the incidence of colorectal cancer in China has been on the rise. According to the epidemiological data of cancer released by the National Cancer Center of China in 2022, there were 408,000 new cases of colorectal cancer and 196,000 deaths in China. The incidence and mortality rates of colorectal cancer ranked second and fourth among all malignant tumors, respectively. Currently, cetuximab is one of the main treatment options for metastatic colorectal cancer with the primary tumor located in the left half of the colon and expressing wild-type RAS EGFR.

Head and neck squamous cell carcinoma (HNSCC) is the most common malignant tumor in the head and neck area. In 2022, there were about 78,000 new cases of HNSCC and over 40,000 deaths in China. The incidence and mortality rates of HNSCC ranks seventh and sixth among all malignant tumors in Chinese men, respectively. Since cetuximab was approved globally for first-line treatment of recurrent or metastatic HNSCC and used in combination with radiotherapy for locally advanced HNSCC, it has allowed many HNSCC patients worldwide to receive treatment plans containing cetuximab, which improved their quality of life and extended their life expectancy.

The application for registration of A140 solution for infusion is based on information from a series of studies, including pharmacologic comparative study, non-clinical comparative study, and clinical comparative study. The Phase III clinical safety and efficacy study of A140 is a randomized, double-blinded, parallel-controlled, multi-centered Phase III clinical study comparing the efficacy, safety and immunogenicity of A140 and the original cetuximab combination chemotherapy regimen (mFOLFOX6 regimen) for first-line treatment of RAS wild-type metastatic colorectal cancer.

About Kelun-Biotech

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech") is a holding subsidiary of Kelun Pharmaceutical. It is committed to the R&D, manufacturing, commercialization, and international cooperation of biotechnological drugs and innovative small molecule drugs. Kelun-Biotech has been committed to addressing medical needs in China and globally. With a key focus on major disease areas such as cancer, autoimmunity, inflammation, and metabolism, it aims to build an international drug R&D and industrialization platform, striving to become a leading innovative enterprise. Kelun-Biotech has made significant progress in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and innovative small molecule drugs with new targets. Kelun-Biotech has successfully established the internationally renowned ADC R&D platform OptiDC, with 4 ADCs investigated in clinical studies (2 of which are in the registration Phase III or NDA stage, respectively), and several ADCs in preclinical studies. Kelun-Biotech currently has 33 innovative projects for the treatment of major diseases such as cancer, autoimmunity, inflammation, and metabolism, including 14 in clinical stage. Several clinical trials are multi-center studies conducted simultaneously in multiple countries including China, Europe and America. For more information, please visit https://kelun-biotech.com/.

To enrich the leisure life of employees, improve their physical fitness, and enhance team cohesion, the labor union of Kelun-Biotech held the seventh badminton match on September 2, 2023. There were 7 participating teams, with nearly 90 employees, at this match. Regular team matches and fun games (juggling, serving, and drawing) were arranged. The participating players fought hard on the court, showcasing the charm of sports competition. The entire event was full of exciting moments.

The match was conducted under the following principle, i.e., " It’s not winning that matters, but friendship and safety". Before the competition, each team took their spare time for serious training to continuously improving their skills in order to get prepared to achieve excellent results. During the competition, they strove hard and sweat on the court. Off the court, each team communicated with one another and made progress together. Meanwhile, the members of the organizing committee and the chief referee took their responsibilities and made fair judgments. Their heart-devoted contrition ensured the smooth running of this badminton match.

Intense battles have unfolded between the teams since the beginning of the match. The players fought for every point with full vigor and vitality, and participated in the competition with full passion, high morale, and a spirit of unity. Although the team members were randomly grouped without good rapport, this does not affect their performance on the field. During the break, the team leaders timely arranged tactics and mobilized their team members to ensure that they sprint on the court in the best condition.

After intense competition, the first, second, and third places were finally determined, and the Excellent Team Award was bestowed. Each team received rewards such as sports backpacks, fascia guns, and badminton strings.

The badminton match is not just a competitive event, but also an opportunity to promote employee communication and cooperation. Through the match, employees not only exercised their bodies and improved their technical skills, but also enhanced friendship and cooperation between departments. Meanwhile, this match fully demonstrates the spirit of our employees who unite as one to make positive and striving efforts, and further highlights the cultural charm of "health, happiness, and confidence" in the company.

From September 2 to 6, 2023, the 2023 China International Fair for Trade in Services (abbreviated as "CIFTIS"), with the annual theme of "Opening up Leads to Development, Cooperation Delivers the Future", was held in Beijing. Only two companies from Sichuan Province were selected, one of which was Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (abbreviated as " Kelun-Biotech "). Kelun-Biotech was successfully selected for the 2023 CIFTIS Ten-Year Achievement Exhibition and as "Demonstration Case for Science & Technology Innovation Service".

This year's CIFTIS has set up a special area for the China Service Trade Achievement Exhibition, presenting the achievements of China's service trade development over the past 10 years. The Sichuan Comprehensive Exhibition Hall covers an area of 100 square meters. Its main thread of display is Chengdu, the innovative demonstration city, and the seven national service export bases. Based on a concentrated display of high-quality physical objects, it showcases the innovative development achievements and characteristic highlights of Sichuan's service trade.

(Kelun-Biotech's large molecular model displayed at the ten-year achievement exhibition of CIFTIS)

Kelun-Biotech reached a cooperation with the international pharmaceutical giant Merck, with upfront and milestone payments totaling up to 11.8 billion US dollars, thereby setting a new record for the amount of foreign authorization transactions for innovative drugs in China. Therefore, it was successfully included in the ten-year achievement exhibition for its historic breakthrough from a basically "importer of services" to "exporter of services".

Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform is one of the only two service demonstration cases selected in Sichuan. Kelun-Biotech's "OptiDC" innovative Antibody Drug Conjugate (ADC) platform has developed a complete ADC core component library, which can design the best combination and make effective optimization according to the biological characteristics of the target, thereby proposing the optimal ADC to meet the medical needs in various indications. With its strong R&D strength and the synergistic effect of multi-platform technology, Kelun-Biotech has become a technology exporter among the world's top biopharmaceutical companies, thus opening a new paradigm of service trade.

Kelun-Biotech Announces Interim Results for 2023:

Global Strategic Partnership and Rich Pipeline Boost Significant Revenue Growth in the First Half of the Year

Chengdu, China, August 28, 2023 – Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, HKEX: 6990.HK), an innovative biopharmaceutical company focusing on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs, announced its interim results for the six months ended June 30, 2023.

The announcement shows that Kelun-Biotech’s revenue for the first half of 2023 amounts to approximately RMB 1,046 million, an increase of 203.3% compared to the same period last year. The increase is mainly attributable to the receipt of the non-refundable upfront payment of USD175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. Thanks to the revenue from license and collaboration agreements, and provision of research and development service, Loss for the period are RMB 31.13 million ，the loss for the period has significantly narrowed by 88.5% year-on-year.

R&D and commercialization work together to contribute to the long-term value accumulation

Kelun-Biotech’s core product, SKB264, was granted a Breakthrough Therapy Designation (BTD) in January, 2023 by the National Medical Products Administration (NMPA) for EGFR-TKI failed EGFR-mutant locally advanced or metastatic NSCLC and another BTD in June for locally advanced or metastatic hormone receptor positive (HR)+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) which has previously received at least 2L systemic chemotherapy. In addition, the clinical development of SKB264 made significant progress in the first half of 2023: In June, the company released the data of phase II study of SKB264 in patients with locally advanced or metastatic NSCLC at the 2023 ASCO Annual Meeting, demonstrating promising efficacy and controlled safety of SKB264; In July, achieved first-patient-in for a pivotal phase III trial of SKB264 for EGFR-mutant locally advanced or metastatic non-squamous NSCLC (TKI failure) in China; In August, the phase III clinical trial of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple negative breast cancer (TNBC) who have failed second-line or above prior standard of care met the primary endpoint.

In May 2023, Kelun-Biotech submitted an NDA to the NMPA for another core product, A166 (HER2 ADC), targeting 3L+ advanced HER2+ BC. The company is also conducting a confirmatory phase III trial in China for 2L+ advanced HER2+ BC and multiple phase Ib clinical trials in China to explore the therapeutic potential of A166 for other advanced HER2+ solid tumors, including gastric cancer and colorectal cancer.

In addition, Kelun-Biotech is making significant progress with other key products. SKB315 (Claudin 18.2 ADC) is undergoing the phase Ia clinical trial in China for patients with advanced solid tumors; The phase Ia clinical trials of SKB410 for advanced solid tumors, which also received IND approval from the NMPA, successfully enrolled the first patient in July 2023; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrollment of the phase III trial of A167 in combination with chemotherapy as a 1L treatment for RM-NPC; We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA.

Considering the research and development progress of its drug pipelines, Kelun-Biotech is setting up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products. Currently, Kelun-Biotech has established a department structure within the company, consisting of various departments such as Marketing, Access and Commerce, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence.

Stable global strategic partnership, Kelun-Biotech has achieved a significant revenue growth

In January 2023, MSD subscribed for the Shares in Kelun-Biotech at a consideration of

approximately USD 1 million as part of the Series B Financing. In March, the receipt of the non-refundable upfront payment of USD 175.0 million from Merck Sharp & Dohme LLC (together with its affiliates, “MSD”) in March 2023 pursuant to the license and collaboration agreement we entered into with MSD to develop up to seven preclinical ADC (antibody drug conjugate) assets for the treatment of cancer. In the first half year of 2023, we had various exchanges and visits with MSD management, and we made concerted efforts to promote the progress of the project and continued to deepen the results of strategic cooperation. Currently, clinical-stage products such as SKB264, SKB315, A410 as well as other preclinical-stage products developed in collaboration with MSD are being advanced and developed in an orderly manner as planned.

Kelun-Biotech entered into a collaboration and license agreement with Ellipses, under which it granted Ellipses an exclusive, royalty-bearing, sublicensable license to develop, manufacture and commercialize A400 in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. Kelun-Biotech has received certain milestone payments from Ellipses during the Reporting Period. A clinical trial application of A400 was approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) in February 2023. As of July 26, 2023, seven and four clinical research centers in the United States and Europe, respectively, were in use for A400.

Strong capital operation promotes innovation strategy

In February, 2023, Kelun-Biotech completed Series B Financing and raised over USD 200 million.

In July, 2023, Kelun-Biotech was successfully listed on the Main Board of the Stock Exchange. The net proceeds arising from the Listing and the full exercise of the Over-Allotment Option amounted to approximately HK$1454.9 million.

Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented: “The significant revenue growth in the first half of 2023 is a strong testament to Kelun-Biotech’s continuous efforts to advance its clinical value-oriented and differentiated oncology and non-oncology pipeline, enhance its drug development capabilities, continue to seek strategic partners, and optimize its operation system, among other correct strategic tactics. Looking ahead to the second half of the year, Kelun-Biotech will further advance the research and development progress of various pipelines, refine the commercialization strategies for each late-stage drug candidate, and continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.”

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.

It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.

Chengdu, China, August 14, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced today that its innovative TROP2-ADC (SKB264, also known as MK-2870) met the primary endpoint in the randomized, controlled, open-label, multi-center Phase III clinical trial of SKB264 for injection versus investigator selected regimens in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed second-line or above prior standard of care.

Kelun-Biotech recently held an Independent Data Monitoring Committee (IDMC) meeting to review the interim analysis data of the Phase III clinical trial of SKB264. The IDMC resolution indicated that the trial met the primary endpoint of progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), and at a pre-specified interim analysis, SKB264 demonstrated a statistically significant improvement in PFS, compared with the control group receiving standardized chemotherapy. Based on the results from the interim analysis, Kelun-Biotech plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China regarding the submission of a new drug application (NDA) of SKB264.

Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech, commented, "TNBC is one of the most aggressive and prevalent subtypes of breast cancer (BC) with huge unmet medical needs. Patients with TNBC who have received second-line or later treatment have an overall survival of 5.2 to 8.4 months [1]. SKB264 has been granted breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic TNBC. For drugs included in the list of BTD, the CDE will prioritize resource allocation for communication and guidance to facilitate drug development. This will help accelerate the development and commercialization of SKB264 to provide high-quality treatment options for patients with advanced TNBC."

SKB264 is one of the core products with independent intellectual property rights of Kelun-Biotech, and will be supported by an extensive development plan. This clinical trial, which met its primary endpoint, is the first registrational Phase III study of SKB264 (MK-2870) in China. In addition, Kelun-Biotech is also advancing a Phase II trial of SKB264 with or without KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) as a first-line treatment for advanced TNBC, and another randomized, open-label, multicenter Phase III clinical study of SKB264 versus investigator’s choice regimens in patients with unresectable locally advanced, recurrent or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who had failed at least one line of chemotherapy is expect to be launched in the second half of 2023.

About SKB264 (MK-2870)

SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors) [2].

SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC), locally advanced or metastatic EGFR-mutated non-small cell lung cancer which has failed EGFR-TKI therapy and locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.

SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic TNBC who have failed at least second-line therapy is progressing smoothly, and SKB264 is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacturing, commercialization, and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, please visit https://kelun-biotech.com/.

References:

[1] O'Shaughnessy, Joyce, et al. Assessment of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) cohort by agent in the phase 3 ASCENT study of patients (pts) with metastatic triple-negative breast cancer (mTNBC). (2021): 1077-1077.

[2] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022

Forward-Looking Statements

This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will,” “would” and the negative forms of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.

It is advised not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.

Chengdu, China, August 1, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990.HK) announced that it will present the data from a Phase I/II clinical trial of the innovative TROP2-ADC (SKB264, MK-2870) jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc Rahway NJ USA) at the European Society for Medical Oncology (ESMO) Congress 2023 to be held in Madrid, Spain from October 20 to 24, 2023. The data will be presented in the form of an oral presentation and will focus on the treatment of previously-treated patients with metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In June of this year, SKB264 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic HR+/HER2- breast cancer which has received at least second-line systemic therapy.

The abstract of this oral presentation is titled "SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): results from a phase I/II, single-arm, basket trial", and the presentation number is 380MO. Details of the abstract are expected to be released on the official website of the ESMO Congress on October 16, 2023, local time.

The ESMO Congress is the most prestigious and influential oncology conference in Europe. It brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all around the world each year. By sharing the latest cutting-edge data, it provides unparalleled networking opportunities and high quality education for oncologists and other stakeholders.

About SKB264 (MK-2870)

SKB264 is an innovative ADC targeting TROP2 which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with DAR of 7.4 (novel topoisomerase I inhibitors) ^[1].

SKB264 has received 3 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer, locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy and the treatment of locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer which has received at least second-line systemic therapy.

SKB264 is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA^?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, visit

http://kelun-biotech.com/.

References:

[1] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology, Vol 12, 2022

Forward-Looking Statements

This press release contains certain forward-looking statements. These statements are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this press release, the words “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “going forward,” “intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,”“seek,” “should,” “will,” “would” and the negative of these words and other similar expressions are intended to identify forward-looking statements. Such statements reflect the current views of our management with respect to future events, operations, liquidity and capital resources, some of which may not materialize or may change.

You are cautioned not to place any undue reliance on any forward-looking statements contained herein. The Company can give no assurance that these forward-looking statements will prove to have been correct. Expectations reflected in these forward-looking statements are subject to change and the Company undertakes no obligation to update or revise any forward-looking statements herein.

Hong Kong, China, July 11, 2023 - Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) announced its official listing on the main board of Hong Kong Exchanges and Clearing Limited (HKEX), with the stock code: 6990.HK. Shares started trading at 60.60 Hong Kong dollars (“HKD”) in the morning. By midday close, Kelun-Biotech’s share price went up by 3.80%, with a total market value of HKD13.58 billion.

As the largest Initial Public Offering (IPO) in the medical and health sector of the Hong Kong stock market in the past two years and one of the most popular investment projects in the medical and health sector recently, Kelun-Biotech’s listing on HKEX has attracted high attention and great interest from both local and international investors.

As a global unicorn enterprise, Kelun-Biotech has established a strategic partnership with Merck Sharp & Dohme LLC (together with its affiliates, “MSD”), one of the top ten multinational pharmaceutical companies in the world, and has entered into nine out-license agreements with MSD to develop up to nine ADC assets with upfront and milestone payments totaling up to USD11.8 billion. In addition, Kelun-Biotech has also received support from blue chip healthcare investors such as IDG Capital, CMG-SDIC Capital, Lilly Asia Ventures, Hillhouse, Cinda, and Sherpa, and has introduced five cornerstone investors including RTW Funds, Laurion Capital Ｍaster Fund, TruMed, CUAM, and Kelun International in this IPO.

Mr. Liu Gexin, Chairman of the Board of Kelun-Biotech said: “As the core subsidiary carrying the innovation mission of Kelun Pharmaceutical, Kelun-Biotech’s successful entry into the international capital market today marks a significant stage victory for Kelun Pharmaceutical’s ‘innovation-driven’ development strategy. With this listing as an opportunity, Kelun-Biotech will continuously improve its corporate governance structure and undertake corporate social responsibilities; accelerate the clinical research of indication-oriented anti-tumor drugs, and expand differentiated non-oncology drug portfolio; focus on key areas, and build more competitive platforms and pipelines. Leveraging Kelun Pharmaceutical’s decades-long experience in the domestic market, and the continuously deepening strategic cooperation with MSD, we will promote the development and commercialization process of planned projects, and strive to become an innovation-oriented pharmaceutical company with a global vision and industry competitiveness, to reward investors and society with excellent performance!"

Since its incorporation in 2016, Kelun-Biotech has been dedicated to the R&D, manufacturing and commercialization of novel drugs in oncology, immunology and other therapeutic areas. Kelun-Biotech is one of the first movers in the development of antibody drug conjugates (ADCs), with over a decade of accumulated experience in ADC development and is one of the first biopharmaceutical companies in China, and one of the few globally, to establish an in-house developed ADC platform, OptiDC. Relying on the platform, Kelun-Biotech has built a strong asset portfolio with 33 highly differentiated and clinically valuable pipelines centered around two ADCs, SKB264 and A166. Among the pipelines, 14 are in clinical stage, five in pivotal trial- or NDA registration-stage, nine in phase 1-or phase 2-stage.

With the Gong ringing and stock market opening at 9:30, the shares of Kelun-Biotech began to trade officially, and received a warm market response. Looking forward, Dr. Ge Junyou, Ｅxecutive Director and General Manager of Kelun-Biotech said: "We will continue to advance and enhance our drug R&D capabilities. In addition to optimizing our R&D platforms and developing novel technologies to support the R&D of innovative drugs, we will strengthen the development of clinical-stage drugs in partnership with strategic partners such as MSD, in the fields of rapid indication expansion, monotherapy and combination therapy, late- and early-line. Furthermore, we will continue to expand cGMP manufacturing and quality control facilities, enhance commercialization system and capabilities, and promote the marketing of more excellent innovative drugs, to bring better treatment options for patients in China and around the world."

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”) is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries and regions including China, Europe, and the United States. To learn more, visit http://kelun-biotech.com/.

On June 19, 2023, Kelun-Biotech announced that the innovative TROP2-ADC (SKB264, also known as MK-2870), which is being developed in collaboration with MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA), in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) for Phase II clinical studies in select patients with a variety of advanced solid tumors, has been approved for clinical trials in the European Union. This is an international multicenter clinical study which is currently approved in multiple countries and territories, including China, the United States, Canada, Australia, and now the European Union, fully demonstrating the strength of Kelun-Biotech in conducting clinical studies on a global scale. MSD and Kelun-Biotech are working closely to continually advance the international development of SKB264.

At present, immune checkpoint inhibitors, mainly represented by anti-PD-1/PD-L1 therapies, have played an important role in treating cancer across a variety of tumors. In order to improve outcomes for patients, combination therapies are being explored, including combination with chemotherapy, targeted therapy, radiotherapy, other types of immunotherapy, and more.

ADCs specifically target tumor cells to deliver cytotoxic molecules that induce immunogenic cell death (ICD) and trigger innate and adaptive immune responses, allowing large numbers of T cells to infiltrate tumor cells and thereby improving immunotherapeutic efficacy. Clinical trial data in multiple cancer types have shown that anti-PD-1 therapies in combination with ADCs may be able to improve efficacy compared to either agent alone. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion, and metastasis, and is a promising target for broad-spectrum anti-tumor therapy. TROP2-ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects, and have shown encouraging anti-tumor activity as monotherapy in several clinical trials, and has the potential to improve anti-tumor efficacy in combination with immune checkpoint inhibitors such as anti-PD-1/PD-L1 therapies.

About SKB264 (MK-2870)

SKB264 is an innovative ADC targeting TROP2 which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with DAR of 7.4 (novel topoisomerase I inhibitors) [2].

SKB264 (MK-2870) has received 2 Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer and locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have failed EGFR-TKI therapy.

SKB264 (also known as MK-2870) is currently conducting Phase II and Phase III clinical trials of monotherapy/combination in multiple solid tumors. In China, the Phase III registrational clinical study of SKB264 monotherapy for patients with advanced or metastatic triple-negative breast cancer (TNBC) who have failed at least second-line therapy is progressing smoothly, and it is expected to become the first domestic TROP2-ADC approved for the Chinese market. Phase III clinical studies of SKB264 monotherapy in patients with TKI-resistant and EGFR-mutated non-small cell lung cancer (NSCLC) are also rapidly advancing. Several Phase II clinical studies of SKB264 in combination with pembrolizumab (KEYTRUDA?, MSD’s anti-PD-1 therapy) or KL-A167 (Kelun’s anti-PD-L1 monoclonal antibody) are ongoing. Kelun-Biotech has licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to research, develop, produce and commercialize SKB264 in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

About Kelun-Biotech

Kelun-Biotech is a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd, which focuses on the R&D, manufacture, commercialization and international cooperation of biotechnology drugs and innovative small molecule drugs. The company focuses on serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease. Building an international drug R&D and industrialization platform to address the unmet clinical needs of the world and China, the Company is committed to becoming an international leading enterprise in the field of innovation. Significant progress has been made in the field of biotechnological drugs, including ADCs, monoclonal antibodies, bispecific antibodies, and sought-after technologies for innovative small molecule drugs. OptiDC, an internationally renowned ADC research and development platform, has been successfully constructed by Kelun-Biotech, and 4 ADCs are in clinical trials (including two in registrational Phase III or NDA filing stage), along with multiple projects in preclinical development. At present, the company has 33 innovative projects for the treatment of serious diseases such as solid tumors, autoimmune, inflammatory, and metabolic disease, and 14 programs are advancing in clinical studies, including multiple global multicenter clinical trials which are being conducted simultaneously in several countries including China, Europe, and the United States.

References:
[1] Merck & Co., Inc. Investor Event at ASCO 2023
[2] Cheng Yezhe, et al. Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132. Frontiers in Oncology. Vol 12, 2022.