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Shares of Biokin Pharmaceutical surged after the Chinese pharmaceutical company announced that its pioneering biospecific antibody-drug conjugate (ADC) cancer treatment received marketing approval in China.
As of 1:25 p.m. in Shanghai, Biokin [SH: 688506] was up 13.7%, trading at CNY258.66 (approximately $38.18).
The drug, Izalontamab Brengitecan (BL-B01D1) injection, has obtained the Drug Registration Certificate from China’s National Medical Products Administration (NMPA) for treating patients with recurrent or metastatic nasopharyngeal carcinoma who have previously undergone at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy, according to the company based in Chengdu.
Iza-bren has participated in over 40 clinical trials targeting various tumor types in China and the U.S., including 19 Phase III studies. It is uniquely the only EGFR×HER3 bispecific ADC to have entered Phase III trials on a global scale, the company stated.
The drug has been recognized in seven different indications as a breakthrough therapy by China’s NMPA Center for Drug Evaluation, with two additional indications added to the list of priority review drugs, and one indication designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA).
Additionally, the application for Iza-bren to treat recurrent or metastatic esophageal squamous cell carcinoma, as well as locally advanced or metastatic triple-negative breast cancer, has been accepted by China’s CDE.
In December 2023, a licensing agreement was finalized with Bristol Myers Squibb, granting the U.S. partner exclusive rights to develop, market, and manufacture BL-B01D1 outside of China and the U.S. The two companies also agreed to share costs related to development and commercialization in the U.S., along with all associated profits and losses. Biokin maintained exclusive rights within mainland China.
Under the terms of the agreement, Bristol Myers Squibb paid Biokin’s U.S. subsidiary an initial sum of $800 million, with potential milestone payments reaching up to $8.4 billion — a record for the largest single-agent ADC licensing deal at that time.
The deal also stipulates that once BL-B01D1 is launched, Biokin will receive tiered royalties based on net sales outside the U.S. and China, while BMS will earn a percentage of royalties from sales within China.
ADC, or antibody-drug conjugates, has become a highly sought-after new class of drugs, with major pharmaceutical companies competing to develop and license these therapies internationally. Unlike traditional chemotherapy, which can damage healthy cells, ADCs are designed to precisely target and eliminate cancer cells, minimizing harm to normal tissue during treatment.
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