On December 28, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Cullinan Oncology, a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, reported an exclusive license agreement for the development, manufacturing and commercialization of CLN-081 in Greater China (Press release, Zai Laboratory, DEC 28, 2020, View Source [SID1234573278]).
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Under the terms of the agreement, Cullinan Pearl, a Cullinan Oncology company, will receive a $20 million upfront payment, with the potential to receive up to an additional $211 million in development, regulatory and sales-based milestone payments. Cullinan Pearl is also eligible to receive high-single-digit to low-teen tiered royalties based on annual net sales of CLN-081 in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Zai Lab obtains the exclusive right to develop, manufacture and commercialize CLN-081 in Greater China.
"Partnering with Cullinan for their potential best-in-class EGFR inhibitor targeting exon 20 insertion (Ex20ins) mutations provides potential synergies with Zai’s existing lung cancer franchise and further strengthens our disease area stronghold in lung cancer," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The unmet need in non-small-cell lung cancer with Ex20ins mutations is significant in China, where EGFR mutation rates are some of the highest in the world. Zai looks forward to working closely with Cullinan to address this large unmet medical need."
"Zai Lab is the ideal partner for innovative drug development and commercialization in Greater China, and we are excited to be collaborating with them on CLN-081," said Owen Hughes, Chief Executive Officer of Cullinan Oncology. "Approved EGFR inhibitors do not adequately address exon 20 insertion mutations. We believe that CLN-081, with its encouraging preliminary efficacy and safety data, can address a significant unmet medical need among lung cancer patients with these mutations. We look forward to working with Zai to initiate development of CLN-081 in China as soon as possible."
About CLN-081
CLN-081 is an orally available, small-molecule, next-generation, irreversible EGFR inhibitor designed to selectively target cells expressing mutant EGFR variants. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFR Ex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy.