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On 8^th March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative  triple negative breast cancer (TNBC). SKB264 (MK-2870) is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA).

This is the fourth Breakthrough Therapy Designation for SKB264 (MK-2870) granted by the NMPA. Previously, SKB264 (MK-2870) was granted BTD for:

• July 2022, locally advanced or metastatic TNBC.

• January 2023, EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitor (TKI) therapy.

• June 2023, locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer in patients who have previously received at least two lines of systematic chemotherapy.

Breast cancer is one of the most common malignant tumors in women, with its incidence showing an increasing trend year by year. The International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) estimated that in 2020, there were over 2.26 million new cases of breast cancer globally, accounting for 11.7% of all tumors, making it the most prevalent cancer [1]. Triple-negative breast cancer (TNBC) is a clinical subtype that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), comprising 10.0% to 20.8% of all breast cancer types. Triple-negative breast cancer is characterized by high heterogeneity, a high rate of recurrence and metastasis, and a poorer prognosis compared to other types of breast cancer. It lacks effective and specific treatment methods [2]. Currently, the primary treatment for PD-L1 negative TNBC is chemotherapy, which offers limited survival benefits, highlighting the urgent need for new treatment plans. For patients with inoperable locally advanced, recurrent, or metastatic PD-L1 negative triple-negative breast cancer, the first-line standard treatment in China still involves chemotherapy, including single-agent or combination chemotherapy [3]. Compared to single-agent chemotherapy, combination chemotherapy has greater toxicity and offers limited survival benefits.

BTD is designed to expedite the development of new drugs for serious diseases that have shown significant efficacy or safety over existing therapies in preliminary clinical trials. For new drugs included in the Breakthrough Therapy List, CDE will prioritize the allocation of resources for communication, enhanced guidance, and promotion of drug development. If the relevant conditions have been assessed to be met, an application for conditional approval and an application for priority review and approval may also be submitted at the time of the application for drug marketing authorization. This will help accelerate the SKB264 (MK-2870) development process and address the unmet clinical needs of Chinese patients as soon as possible.

参考文献：
[1] Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J(Engl).2022 Feb 9; 135(5):584-590.
[2] 三阴性乳腺癌含铂方案临床应用专家共识（2021版）.中华肿瘤防治杂志2021年6月第28卷第12期.
[3] 《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2023版》.

Our key product A400(EP0031), a small molecule rearranged during transfection (RET) kinase inhibitor program, has been granted Fast Track designation by the United States Food and Drug Administration (FDA) for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).

A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations.

• In March 2021, the Company granted Ellipses Pharma Limited, a U.K.-based international drug development company, an exclusive, royalty-bearing, sub licensable license to develop, manufacture and commercialize A400 (EP0031) in all countries excluding Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. 

• In June 2022, the FDA approved an investigational new drug application for A400 (EP0031), and a phase 1/2 trial is ongoing in patients with malignant tumors with RET gene alteration. 

• In November 2023, A400 was granted Orphan Drug Designation by the FDA for the treatment of RET fusion-positive solid tumors.

In preclinical studies, A400 (EP0031) demonstrated favourable inhibitory activity against key RET kinases in-vitro and in-vivo. A400 (EP0031) also demonstrated good penetration of the blood brain barrier in animal models. Data shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on A400 (EP0031) showed promising anti-tumor efficacy in patients with advanced RET+ solid tumors, highlighted by ORR of 80.8% and 69.7% for 1L and 2L+ advanced RET+ NSCLC, respectively, based on results from its ongoing phase 1/2 trial. In both cases, DCR of over 96% were reported.

At present, the Company is conducting A400 (EP0031) pivotal clinical study in China for RET- positive NSCLC.

About Ellipses Pharma Limited

Ellipses Pharma is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients.

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 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical 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 four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.

pursuant to the Notice of Adjustment of Stock List of Southbound Trading Link of the Shanghai-Hong Kong Stock Connect ( 关于沪港通下港股通目标调整的通知) made by the Shanghai StockExchange on March 1, 2024, the Company will be included in the list of eligible shares of the Southbound Trading Link of the Shanghai-Hong Kong Stock Connect with effect from March 4, 2024.

On February 21, 2024, the prestigious international finance magazine, FinanceAsia, held its 2023 annual achievement awards ceremony in Hong Kong. Kelun-Biotech (6990.HK) was invited to attend the celebration dinner and was awarded the "Best IPO in Asia and Hong Kong for 2023" honor.

FinanceAsia is regarded as one of the most representative professional monthly magazine in Asia's capital market and has significant influence in the investment industry. Founded in 1996, its sponsored "FinanceAsia Achievement Awards" is one of the most influential and credible industry award selections in the Asia-Pacific region, the award ceremony is an significant annual gathering in the investment industry.

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 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical 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 four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.

Clinical trials in non-small cell lung cancer (NSCLC) and endometrial cancer (EC) conducted by Kelun-Biotech and Merck Sharp & Dohme for the core product of the collaboration, SKB264 (MK-2870), have triggered relevant clinical milestone payments totaling $75.0 million. The Company has received a portion of the payment from Merck Sharp & Dohme and expects to receive the balance in the near future.

Collaboration Update:

In May 2022, Kelun-Biotech granted Merck Sharp & Dohme exclusive rights to develop, manufacture and commercialize SKB264 (MK-2870) in all territories outside of Greater China.

Merck Sharp & Dohme announced that it has initiated three pivotal Phase 3 clinical trials evaluating SKB264 (MK-2870) as a monotherapy for the treatment of previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations or other genomic alterations, as a monotherapy for the treatment of endometrial cancer (EC) previously treated with platinum-containing chemotherapy and immunotherapy, and with pabopoetin. ), and in combination with pembrolizumab for metastatic NSCLC with programmed death ligand 1 (PD-L1) expression greater than or equal to 50%.

Based on written confirmation from Merck Sharp & Dohme, clinical trials in NSCLC and EC have triggered related clinical milestone payments totaling $75.0 million. The Company has received a portion of the payment from Merck Sharp & Dohme and expects to receive the balance in the near future.

About SKB264 (MK-2870, trade name: Jatelle)

SKB264 is a representative and innovative ADC targeting TROP2 developed by OptiDC, the internationally renowned ADC development platform of Kelun-Biotech. SKB264 consists of a humanized anti-TROP2 monoclonal antibody with high affinity and targeting properties, which is conjugated to the toxin small molecule T030 (topoisomerase I inhibitor) through the stability-optimized CL2A linker. T030 (topoisomerase I inhibitor) with an average drug-antibody ratio (DAR) of 7.4. The stability of SKB264 is enhanced in two ways, allowing more ADCs to reach tumor cells. On the one hand, the antibody end of the linker uses a methylsulfonylpyrimidine linker that irreversibly couples to the antibody, and on the other hand, T030 contains a methylsulfone structure that binds stably to the toxin end of the linker.SKB264's linker combines both extracellular pH-sensitive cleavage of the tumor cell and intracellular enzymatic cleavage of the tumor cell, which allows for the highly efficient release of the toxin's small molecules and the exertion of an antitumor effect.The activity of T030 is comparable to that of DXd and has a bystander effect. In summary, SKB264 has a triple antitumor effect: first, the pH-sensitive linker can be cleaved to release T030 in the acidic tumor microenvironment; second, SKB264 can be endocytosed into the tumor cell and then cleaved to release T030 by zymotics; finally, T030 can transcend the cell membrane to exert the bystander effect to kill the surrounding tumor cells. Finally, T030 can pass through the cell membrane and exert a “bystander effect” to kill the surrounding tumor cells. Good stability, high affinity antibody, high DAR value, high active toxin, triple anti-tumor effects become the cornerstone of SKB264's potent anti-tumor effect, which has also been initially confirmed in clinical studies.

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/.

2023 Work Summary Report

With the theme of “Improve Quality, Increase Efficiency and Start a New Era”, the meeting listened to the work reports of 13 persons in charge of the Innovation Clinical, Innovation R&D, Translational Medicine, Innovation Production, and Marketing Sections. Facing the current severe situation and challenges, the persons in charge of each segment summarized and analyzed the work in 2023 by focusing on the three core elements of “Quality, Efficiency and Cost” with issues and results as the guide, and benchmarked with comparable companies in the industry with quantifiable data, and summarized and reported on the promotion of key work, project progress, and achievement of performance targets in the year of 2023. It summarized and reported the progress of key work, project progress, achievement of performance targets and problems and deficiencies in 2023, and clarified the work objectives and plans for 2024. Participating leaders made in-depth, detailed and constructive comments on the work of each segment one by one.

The year of 2023 is a year for Kelun-Biotech to overcome difficulties and make progress at a high level. In this year, the registration applications of Sutera (A166), Datatelec (A140) and Jatatelec (SKB264) were formally accepted by CDE successively; we worked with our partners to lay out the global clinical research; the clinical value of our core programs was continuously explored and rapidly verified, and the data of the clinical research of A400 and SKB264 were continuously released in the top international academic conferences and attracted the attention of international counterparts and investors. The clinical data of A400 and SKB264 were continuously published in top international conferences and attracted the attention of international peers and investors.

During the year, through continuous optimization of the alliance management process, we established a comprehensive technical communication system with Merck Sharp & Dohme to promote in-depth cooperation; we fully absorbed the industry's excellence, formed a commercialization team with strong competitiveness, and began to comprehensively start the construction of commercialization capacity; we seized the opportunity to be listed on the Stock Exchange of Hong Kong (6990.HK), and was awarded the FinanceAsia 2023 Hong Kong's Best IPO Award. Award. These achievements signify that Kelun-Biotech is undergoing a qualitative metamorphosis, and Kelun's innovation-driven development strategy has achieved a major milestone victory.

Management team speech

Dr. Junyou Ge, Chief Ｅxecutive Officer of Kelun-Biotech, said that in the past year, under the correct leadership of the Chairman and the Board of Directors as well as the management team, all the staffs have overcome the difficulties, continued to deepen the reform, focused on the strengths, increased the speed and efficiency, and maintained the forward momentum of high-quality development, and achieved better results. 2024 will be the beginning of a new year for Clonbuterol and it is necessary to work hard to promote the registration process of A167, SKB264, A167, SKB264, A166, A140, etc. We will strive to push forward the registration process of A167, SKB264, SKB264, A166, A140, etc., and strive to ensure that they will be listed on the market according to the plan and on schedule, so as to realize the closed loop of ColumboTech's R&D, clinic and commercialization.

Focusing on the goals and plans for 2024, Dr. Ge Junyou put forward four requirements: firstly, we should practice the corporate culture of “scientific truth-seeking”, and every scientist should follow the spirit of truth-seeking and pragmatic scientists, dare to speak and tell the truth, and give true and objective opinions according to their duties. Secondly, we should improve efficiency, solve process redundancy, reduce and avoid ineffective, formalistic meetings; R&D leaders and management cadres should go to the front line to find and solve problems. Thirdly, we should strengthen team building, enhance the introduction of high-end talents in core technology areas, start the “bench” program, and strengthen the cultivation and guidance for high-potential, high-quality employees and successors, so as to lay a solid foundation for the everlasting success of the company. Fourthly, we should keep an open mind, think in terms of “compound interest”, and make full use of AI and other revolutionary technologies to improve the quality and efficiency of R&D work, so as to be invincible.

Dr. Ge Junyou concluded that the current international, economic and innovation environment is very severe. We have to face up to the severe situation and challenges, do our own thing under the difficult environment, exert the mentality and logic of a strong man, and practice the Group's “20-word policy” to usher in a new and effective growth.

 Management team speech

Mr. Liu Gexin, Chairman of Coren Group and Coren Kelun-Biotech, delivered an important speech to express his heartfelt thanks to all the colleagues for their hard work and excellent contributions. Mr. Liu Innovation, Chairman of the Board of Directors, spoke about: 2023 is a year of excitement for Coren, Chuanning Bio and Coren Botay were successfully spun off and listed on the stock market, and Coren Group has formed an operation pattern supported by three major capital platforms in the shape of the character of “Pin”; and the strong alliance between Coren Medical Trade and China Resources marks the formation of a new ecology in China's pharmaceutical industry, which is of extraordinary significance! The world is in a situation of unprecedented change, a new round of scientific and technological revolution and industrial change accelerate the evolution.

The chairman of the board of directors then put forward to strengthen the innovation of international cooperation, fully embrace the new technology, expand the innovation track and a number of insightful industry forward-looking suggestions, and finally encouraged all employees: “Opportunity is in the time you are not ready to appear, so first take the china work, and then look for diamond diamonds”;” One person, one family, one team, what kind of ideal, there will be what kind of future, please firmly believe in Coren's “striver-oriented” core values and the strong vitality of the Ｅxecutive culture! The door to an era of strength and innovation is opening, and flowers are blooming in front of us.”

Award Ceremony for Recognition of Advancement

The meeting also held an award ceremony to recognize the advanced in 2023. Award certificates, trophies and prizes were presented to advanced individuals, advanced teams and innovative drug NDA project teams. The chairman of the board of directors and the leaders of the meeting expressed warm congratulations to all the award-winning employees and teams, and the team employees were highly encouraged.

In the year of 2024, all the staff will continue to make progress, work hard, and contribute to the company's effective growth in R&D and innovation, and create a brilliant future together.

The 42nd J.P. Morgan Annual Healthcare Conference（“JPMHC”）2024 is taking place on January 8-11 at San Fracisco, USA, members of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech) senior management team participated in the conference. Dr. Micheal Ge, CEO of Kelun-Biotech, delivered a presentation about innovation strength and business progress of Kelun-Biotech.

Presentation Title: Dedicated to human health with a caring heart

Presentation Time: Pacific Standard Time (PST) Tuesday 8:00 AM, January 9, 2024

As one of the pioneers in the antibody-drug conjugates (ADC) development company, Kelun-Biotech has established world leading ADC platform “OptiDC?”, as well as a rich and differentiated ADC R&D pipeline covers unmet clinical needs in the field of oncology. Our core product Trops-ADC and Her2 ADC are expected to be approved for NDA in China this year. Meanwhile, Kelun-Biotech is accelerating the development progress of over 10 clinical and pre-clinical ADC and ADC-derivative products. With the support of the Kelun Group, Kelun-Biotech has built mature R&D, manufacturing and quality control system, the company is now building a commercialization team to form the marketing system. Kelun-Biotech’s innovation capability has gained high recognition from global partners, including MSD, and the capital market. Kelun-Biotech is rapidly developing a unique growth curve as an ADC R&D pharmaceutical enterprise.

Dr.Michael Ge said: “It’s our pleasure to meet again with global industry leaders, innovative technology creators and members of the investment community here at JPMHC. Our top priority is to rapidly advance our differentiated pipeline programs into and through the clinic for disease conditions with significant medical needs. We will continue to innovate and optimize our ADC platform, discover novel payloads, linkers, engineer novel ADC designs, and expand clinical application of antibody drug conjugates to non-oncology disease areas. Build upon our end-to-end drug development capabilities, infrastructure, and commercialization readiness. Furthermore, we plan to extend our global footprints through strategic partnerships and maximize our pipeline and portfolio value. We look forward to achieving and updating you on the 2024 milestones in the coming year”.

Presentation Slides is available on the investor relations page of Kelun-Biotech website at: 投资者关系 - 四川科伦博泰生物医药股份有限公司 (kelun-biotech.com)

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 33 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including 14 projects in the clinical 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 four ADC projects in the clinical stage (two of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.