YICAI | China's Biokin Soars After Its First-in-Class Cancer Drug Is Greenlit for Chinese Market Launch
(Yicai) June 23 -- Shares of Biokin Pharmaceutical climbed after the Chinese drugmaker said its global first-in-class biospecific antibody-drug conjugate cancer therapy received marketing approval in China.
Biokin [SHA: 688506] was trading up 13.7 percent at CNY258.66 (USD38.18) as of 1.25 p.m. in Shanghai today.
Izalontamab brengitecan (BL-B01D1) injection has secured the Drug Registration Certificate from the National Medical Products Administration to treat patients with recurrent or metastatic nasopharyngeal carcinoma who previously failed at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor therapy, the Chengdu-based company announced yesterday.
Iza-bren has conducted over 40 clinical trials targeting various types of tumors in China and the United States, including 19 Phase III clinical studies. It is the only EGFR×HER3 bispecific ADC to have entered Phase III clinical trials globally, according to Biokin.
Iza-bren has seen seven indications included in the list of breakthrough therapies by the NMPA's Center for Drug Evaluation, two indications added to the list of priority review drugs by the CDE, and one indication classified as a breakthrough therapy by the US Food and Drug Administration, the company noted.
Moreover, the New Drug Applications for iza-bren to treat recurrent or metastatic esophageal squamous cell carcinoma and locally advanced or metastatic triple-negative breast cancer have been accepted by the CDE, Biokin added.
In December 2023, Biokin entered into a licensing deal with Bristol Myers Squibb to grant the US peer exclusive rights to develop, commercialize, and produce BL-B01D1 in overseas markets except for China and the US. The pair also agreed to share the drug's development and commercialization costs in the US, as well as all profits and losses there. Biokin retained exclusive rights in the Chinese mainland.
Based on the agreement, BMS paid Biokin's US subsidiary an upfront payment of USD800 million and pledged to transfer up to USD8.4 billion in milestone payments, setting a record for the largest single-agent ADC licensing deal globally at that time.
The deal also stipulated that after the launch of BL-B01D1, Biokin will receive tiered royalties based on net sales in markets outside the US and China, and BMS will get a certain percentage of royalties from the net sales in the Chinese mainland.
ADC is a popular new drug category that pharmaceutical giants have been vying for in recent years, as well as the main type of innovative drug that Chinese firms are licensing out abroad. Unlike traditional chemotherapy, which can harm healthy cells, ADC precisely targets and kills cancer cells, reducing damage to normal cells during treatment.