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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.
China’s Jiangsu Hengrui Pharmaceuticals Co. Ltd. is launching a new biotech company called Luzsana Biotechnology that will develop and commercialize Hengrui assets in the U.S., Europe and Japan. A wholly owned subsidiary of Hengrui, Luzsana, which means “healing light,” will develop innovative products from Hengrui’s pipeline.
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.
Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market.
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.
Shanghai Heartcare Medical Technology Corp. Ltd. received marketing approvals for three medical devices designed for stroke, namely its left atrial appendage (LAA) occluder, the aspiration catheter, and the support catheter.
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. In addition, Orion could pay the Chinese company development, commercialization, and sales milestones that Orion suggested could be “significant,” as well as tiered royalties of 8% to 15% based on future sales.
Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market.
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.
Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
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