On 23 February, 2023, Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) and Keymed Biosciences Inc., (“Keymed”) (Stock Code: 02162 HK) today jointly announces a global exclusive licence agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.

CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors. Preliminary results from the Phase 1 trial indicated that CMG901 has a favorable safety and tolerability profile, and encouraging anti-tumor efficacy across the dose levels tested.

Financial Considerations

Under the terms of the agreement, KYM Biosciences, the joint venture established by Lepu Biopharma and Keymed, on transaction closing and additional development and sales-related milestone payments of up to US$1.1 bn as well as tiered royalties up to low double-digits. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

Dr. Bo Chen, Chief Executive Officer of Keymed and Board Chairman of KYM said, “We are pleased to have partnered with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies. This is not only a recognition of CMG901, a potential first-in-class Claudin 18.2 ADC, but also Keymed’s internal discovery and development capabilities. The global scope of this agreement has the potential to benefit patients in China, and throughout the world.”

Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, “We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers. CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform outcomes for patients with gastrointestinal cancers.”

About CMG901

CMG901 is a novel antibody drug conjugate targeting Claudin 18.2, and consists of an anti-Claudin 18.2 monoclonal antibody, a protease-degradable linker, and a cytotoxic small molecule monomethyl auristatin E (MMAE). CMG901 is being developed for the treatment of solid tumours that express the cell surface protein Claudin 18.2, including gastric cancers. CMG901 is owned by KYM Biosciences Inc. (KYM), a joint venture established by affiliates of Keymed Biosciences (70% of KYM ownership) and Lepu Biopharma (30% of KYM ownership). AstraZeneca has entered into a definitive agreement for an exclusive global license to CMG901 from KYM, reflecting AstraZeneca’s strategy to invest in antibody drug conjugates and expand its portfolio in gastrointestinal (GI) cancers.

About Lepu Biopharma Co., Ltd.

Lepu Biopharma Co., Ltd. (Stock Code: 02157.HK) is an innovation-driven company and dedicated to discovering, developing, and commercializing first-in-class and best-in-class drug candidates in anti-tumor targeted therapy and oncology immunotherapy in China and globally. The Company highly values the continuing build-out of its own commercialization capabilities and is determined to pursue the goal towards strong transformation from core technology to drugs and industrialization. At present, the product pipeline of LEPU BIOPHARMA covers three major areas, namely immunotherapies, ADC targeted therapies and oncolytic virus drugs, including 1 commercial drug , 7 clinical-stage drug candidates (5 of which are ADC drug candidates) and multiple clinical-stage combination therapies of the key candidates in its pipeline. The company houses the leading ADC drug candidate pipeline in China.

About Keymed Biosciences Inc.

Keymed Biosciences Inc. (Stock Code: 02162 HK) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in the United States and China. Developing antibodies with first-in-class and best-in-class therapeutic potential, Keymed has built a diversified pipeline addressing cancer and autoimmune diseases with over 30 self-developed Class I novel drug candidates, 9 of which have already entered clinical trial stages. The Company was listed on the main board of Hong Kong Stock Exchange on July 8, 2021.

Media Contacts

Lepu Biopharma Co., Ltd.

Tel：021-6768 0899

Email：pr@lepubiopharma.com

Keymed Biosciences Inc.

Tel: 028-88610620

Email: pr@keymedbio.com