Keymed Biosciences Inc., and Lepu Biopharma Co., Ltd., have entered into exclusive license agreement with AstraZeneca for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC).

Under the terms of the agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally.

“We are pleased to have partnered with AstraZeneca, a global biopharmaceutical company with leadership in developing and commercializing novel anti-cancer therapies,” said Bo Chen, CEO, of Keymed and board chair of KYM.  “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.”

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.

Also under the terms of the agreement, KYM Biosciences, the joint venture established by Keymed and Lepu Biopharma, will receive an upfront payment of $63 million on transaction closing and additional development and sales-related milestone payments of up to $1.1 billion as well as royalties.

The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.