(Yicai) June 23 -- Biokin Pharmaceutical’s stock price climbed after the Chinese drugmaker said its first-in-class biospecific antibody-drug conjugate for treating breast and lung cancers received marketing approval in China.

Biokin [SHA: 688506] finished 11 percent higher at CNY252.43 (USD37.21) per share in Shanghai today, though the stock is still down 22 percent since the end of last year.

Izalontamab brengitecan (BL-B01D1) injection has received a Drug Registration Certificate from China’s National Medical Products Administration for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy, the Chengdu-based company announced late yesterday.

Iza-bren has been tested in more than 40 clinical trials across multiple tumor types in China and the United States, including 19 Phase III studies, and remains the only EGFR×HER3 bispecific ADC in global Phase III development, according to Biokin.

ADCs have become one of the hottest drug classes in global pharma and a major category of innovative drugs Chinese biotech firms are licensing abroad. Unlike conventional chemotherapy, which can damage healthy cells as well as cancer cells, ADCs are designed to deliver toxic payloads directly to cancer cells, reducing harm to normal tissue during treatment.

Biokin said seven indications for iza-bren have been added to the NMPA’s Center for Drug Evaluation breakthrough-therapy list, two have been placed on the CDE priority-review list, and one has been designated a breakthrough therapy by the US Food and Drug Administration.

The New Drug Applications for iza-bren in recurrent or metastatic esophageal squamous cell carcinoma and locally advanced or metastatic triple-negative breast cancer have been accepted for review by the CDE, it added.

In December 2023, Biokin struck a licensing deal with Bristol Myers Squibb that gave the US drugmaker exclusive rights to develop, commercialize, and produce BL-B01D1 in overseas markets outside China and the US. The pair also agreed to share the drug’s US development and commercialization costs, as well as all profits and losses there. Biokin retained exclusive rights in the Chinese mainland.

Under the deal, BMS paid Biokin’s US subsidiary USD800 million upfront and agreed to make milestone payments of as much as USD8.4 billion, at the time a record for the largest global out-licensing deal for a single ADC asset.

The deal also provides for Biokin to receive tiered royalties on net sales outside the US and China after launch, while BMS will receive a share of net sales in the Chinese mainland.

Editor: Futura Costaglione