On June 22, BL-B01D1 (Iza-bren), the world’s first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC) developed by Biokin Pharma, received marketing approval from China’s National Medical Products Administration (NMPA). As the first and currently the only approved bispecific ADC worldwide, it is indicated for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following prior therapy.

This approval represents a major milestone for Biokin Pharma, reshaping the landscape of cancer treatment, ushering in a new era of bispecific ADC therapeutics, and marking an important step in the company’s evolution toward becoming a multinational pharmaceutical company (MNC).

As a close development partner of Biokin Pharma, InnoStar leveraged its standardized GLP laboratory system that complies with the requirements of the NMPA, FDA, and OECD to provide comprehensive nonclinical pharmacokinetic (PK) studies and safety assessment services for BL-B01D1 (Iza-bren) throughout its development. From IND-enabling studies through NDA/BLA submission, InnoStar delivered integrated nonclinical development support aligned with international regulatory standards, providing the critical nonclinical foundation that helped accelerate the approval of the world’s first-in-class bispecific ADC.

The program entered into a global collaboration with Bristol-Myers Squibb (BMS) in 2023, with a total potential deal value of US$8.4 billion, including an upfront payment of US$800 million. Under the agreement, BMS and Biokin Pharma are jointly responsible for the global development and commercialization of BL-B01D1 (Iza-bren).

The nonclinical data generated by InnoStar in compliance with NMPA, FDA, and OECD requirements not only supported the program’s clinical trial authorization and Breakthrough Therapy Designation (BTD) in China, but also contributed to its U.S. FDA Breakthrough Therapy Designation and supported global regulatory submissions for multi-regional clinical development.

The approval for nasopharyngeal carcinoma marks only the first approved indication for BL-B01D1 (Iza-bren), with the drug’s broader clinical potential continuing to unfold. Currently, 19 Phase III (including Phase II/III) clinical trials are underway across multiple epithelial malignancies, including esophageal squamous cell carcinoma, breast cancer, lung cancer, biliary tract cancer, and urothelial carcinoma. Marketing applications for multiple additional indications have also been submitted.

Committed to advancing innovative drug development, InnoStar delivers compliant, high-quality, and globally oriented nonclinical development services that help innovative biopharmaceutical companies accelerate the journey from laboratory research to global markets. As of December 31, 2025, InnoStar has supported 35 successful NDA/BLA approvals and more than 830 successful IND submissions worldwide. The company has also contributed to the clinical authorization of more than 140 programs by regulatory authorities outside China, including those in the United States, the European Union, South Korea, and Australia, with three FDA NDA/BLA approvals among them. Looking ahead, InnoStar will continue to empower innovative drug developers in advancing the simultaneous development of original therapies in China and global markets, helping bring innovative treatments to patients worldwide.