Jacobio Out-licenses KRAS G12C and SHP2 Inhibitors to Allist in China

Jacobio Pharma, a clinical-stage oncology company focused on undruggable targets, has announced a significant partnership with Shanghai Allist Pharmaceuticals. The agreement grants Allist the rights to commercialize Jacobio's KRAS G12C inhibitor, glecirasib, and SHP2 inhibitor, JAB-3312, in China, including mainland China, Hong Kong, Macau, and Taiwan. 

As part of the agreement, Jacobio will receive an initial payment of approximately RMB200 million, of which RMB150 million is an upfront payment. An additional RMB50 million will cover research and development expenses and other related costs. Moreover, Jacobio stands to earn up to RMB700 million in milestone payments contingent upon the achievement of specific development, regulatory, and commercial milestones. The company will also benefit from tiered double-digit royalty payments on the net sales of both drugs in China, with royalties on JAB-3312 sales reaching up to 20%. These figures include value-added tax.

Allist will be responsible for the commercialization efforts of both glecirasib and JAB-3312 in China, and it will fund the subsequent clinical development costs within the region. This collaboration signifies Jacobio's official entry into the commercialization phase and marks a significant milestone in the development of SHP2 inhibitors.

Dr. Wang Yinxiang, Chairman and CEO of Jacobio, expressed his enthusiasm about the partnership, highlighting Allist's strong capabilities in the field of lung cancer, which align well with Jacobio's objectives. He noted that the collaboration would leverage the strengths of both companies, enhancing the clinical and commercial value of their products. Dr. Wang also emphasized the potential of JAB-3312 to become a first-line therapy in combination with glecirasib, underscoring Allist's foresight in pipeline development.

Jinhao Du, Chairman and General Manager of Allist, echoed these sentiments, noting that the partnership would benefit both companies. He highlighted Allist's commitment to scientific exploration and drug development in oncology, citing their successful development and launch of furmonertinib. Du expressed optimism about the clinical advantages and market potential of glecirasib and JAB-3312, emphasizing Allist’s dedication to leveraging its strengths in clinical development and commercialization to benefit Chinese patients and create value for both companies.

The glecirasib monotherapy for second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation is currently under priority review. In December 2022, it received breakthrough therapy designation from the National Medical Products Administration (NMPA) for the treatment of advanced or metastatic NSCLC with KRAS G12C mutation. Data from a pivotal Phase II study presented in April 2024 indicated a confirmed objective response rate of 47.9% among patients, with a disease control rate of 86.3%, a median progression-free survival of 8.2 months, and a median overall survival of 13.6 months.

In August 2024, the first patient was dosed in a Phase III clinical trial comparing glecirasib and JAB-3312 with standard care for front-line KRAS G12C mutant NSCLC. Phase I/IIa data showcased a 77.4% objective response rate in the optimal dose group, with 54.8% of patients experiencing significant tumor reduction. Safety data revealed a manageable incidence of grade 3 or 4 treatment-related adverse events (TRAE) at 43.8%, with no treatment-related deaths.

Glecirasib is also being studied for its efficacy in pancreatic and colorectal cancers. In April 2024, it received orphan drug designation from the FDA for pancreatic cancer and breakthrough therapy designation in China for the same indication. Additionally, the combination of glecirasib and cetuximab for colorectal cancer was approved for a registrational Phase III clinical trial in China in May 2024.

Jacobio Pharma, based in Beijing, Shanghai, and Boston, focuses on developing innovative oncology treatments, while Allist Pharmaceuticals, founded in 2004 and listed on the Shanghai Stock Exchange, specializes in the research, development, manufacturing, and commercialization of novel oncology drugs.

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