Zhejiang Acea Pharmaceutical Co. Ltd. failed to obtain marketing approval from China’s NMPA for its third-generation EGFR tyrosine kinase inhibitor, abivertinib. The NDA was based on a phase II trial of abivertinib in patients with EGFR Thr790Met point mutation-positive non-small-cell lung cancer with disease progression from prior EGFR inhibitors.
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
Orion Corp. has secured exclusive global rights, outside China, to a non-opioid pain drug candidate from Jiangxi Jemincare Group Co. Ltd. The deal, for oral sodium channel inhibitor JMKX-000623, brought Jemincare €15 million (US$15.6 million) up front.
A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants.
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA.
Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform.
As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers.
Juniper Biologics Pte. Ltd. has added another candidate to its pipeline in the space of less than a month. In the latest deal, the Singapore-based company inked an exclusive licensing agreement with Switzerland’s Helsinn Healthcare SA, gaining rights to develop and commercialize oncology drug infigratinib in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa.
Hansoh Pharmaceutical Group Co. Ltd. has acquired greater China rights to oncology candidate NKT-2152 from Nikang Therapeutics Inc. in a deal worth up to $218 million. Jiangsu, China-based Hansoh picked up exclusive rights to develop and commercialize the candidate in mainland China, Hong Kong, Macau and Taiwan. In turn, Nikang is eligible to receive $15 million up-front cash payment, as well as up to $203 million in potential development, regulatory and sales-based milestone payments, and tiered royalties.
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