Biokin Pharma books $250M milestone from BMS, as star ADC Iza-bren's China NDA gets accepted

Biokin Pharmaceutical announced that its subsidiary, SystImmune, has received a milestone payment of USD 250 million (approximately RMB 1.769 billion, subject to bank charges deduction) from Bristol Myers Squibb (BMS).

According to the collaboration agreement, the company remains eligible to receive up to an additional USD 250 million in contingent near-term payments, as well as further payments of up to USD 7.1 billion upon the achievement of specified development, regulatory, and sales performance milestones. The milestone payments stipulated in the agreement are contingent upon meeting certain conditions. The realization of the final milestone payments remains subject to uncertainty.

This milestone payment originates from the collaboration between Biokin Pharmaceutical and BMS established two years ago. In December 2023, SystImmune, a wholly-owned subsidiary of Biokin Pharmaceutical, and BMS announced an exclusive license and collaboration agreement for BL-B01D1. The announcement at that time disclosed that BMS would pay SystImmune an $800 million upfront payment, along with up to $500 million in contingent near-term payments. Upon achieving specific development, regulatory, and sales milestones, SystImmune is eligible to receive additional payments of up to $7.1 billion. The total potential transaction value could reach up to $8.4 billion, setting a global record for the highest single-drug total deal value in an ADC out-licensing agreement.

The two parties will jointly share the global development costs for BL-B01D1 and will share profits and losses in the U.S. market. SystImmune, through its affiliates, retains the exclusive development and commercialization rights for BL-B01D1 in mainland China, and Bristol Myers Squibb will receive royalties on net sales from mainland China. Outside the United States and mainland China, SystImmune will receive tiered royalties on net sales. By March 7, 2024, SystImmune had already received the $800 million upfront payment from BMS, which is non-refundable and non-creditable.

Iza-bren (BL-B01D1) is the world's first and only bispecific EGFR×HER3 ADC to have entered Phase III clinical trials. As of September 2025, Biokin Pharmaceutical is conducting 40 clinical trials for iza-bren targeting various tumor types in China and the United States. This includes 10 Phase III registration studies for different cancer types underway in China (7 of these indications have been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation of China's National Medical Products Administration). In the United States, in partnership with its strategic collaborator BMS, Biokin is jointly conducting a Phase II/III clinical trial for first-line advanced triple-negative breast cancer, a Phase II/III trial for advanced non-small cell lung cancer (NSCLC) after EGFR-TKI resistance, and a Phase II/III trial for previously treated advanced metastatic urothelial carcinoma, as well as several Phase I/II clinical trials for NSCLC and advanced solid tumors.

As a first-in-class drug, research results for iza-bren have been successively presented at major global academic conferences including ASCO, WCLC, ESMO, and SABCS over the past two years and have been published in full in the top-tier academic journal The Lancet Oncology, demonstrating promising efficacy signals and a manageable safety profile. For example, at this year's European Society for Medical Oncology (ESMO) Congress, Biokin presented clinical data for iza-bren in Western patients with solid tumors for the first time. The results showed that the efficacy of iza-bren was highly consistent between Eastern and Western patient populations, validating its significant therapeutic potential across different demographics and a variety of tumor types.

On September 30, 2025, a milestone in the global Phase II/III key registration clinical trial IZABRIGHT-Breast01 for iza-bren was achieved, triggering the condition for the first $250 million contingent near-term payment under the collaboration agreement. This milestone payment was successfully received in November.

On November 21, 2025, the New Drug Application (NDA) for iza-bren was successfully accepted for review by China's National Medical Products Administration (NMPA), with the potential poised to launch first in China in 2026. This marks the successful acceptance of the first marketing application for iza-bren and is also the first successful acceptance of a New Drug Application globally for a bispecific EGFR×HER3 antibody-drug conjugate. Currently, the collaboration between Biokin Pharmaceutical and BMS is progressing smoothly. The two parties are jointly conducting three global key registration studies worldwide: a Phase II/III registration trial for first-line advanced triple-negative breast cancer, a Phase II/III trial for advanced NSCLC after EGFR-TKI resistance, and a Phase II/III trial for previously treated advanced metastatic urothelial carcinoma, along with several Phase I/II clinical studies for NSCLC and advanced solid tumors.

On the technology front, after years of innovation and accumulation, Biokin has established several proprietary drug R&D platforms with global rights and full intellectual property ownership. These include the HIRE-ADC platform (for ADC drugs), the GNC platform (for innovative multi-specific antibody drugs), the SEBA platform (for specificity-enhanced bispecific antibodies), and the HIRE-ARC platform (for innovative ARC radiopharmaceuticals). As of mid-2025, Biokin had filed a total of 723 patent applications, including 119 in China, 59 in the United States, 58 under the Patent Cooperation Treaty (PCT), and 487 in other jurisdictions. Biokin has been granted a total of 213 patents, comprising 81 in China, 14 in the United States, and 118 in other jurisdictions.

Leveraging these technology platforms, Biokin has successfully developed a pipeline including 3 assets in Phase III clinical trials (2 ADC drugs and 1 bispecific antibody), 12 core early-stage clinical assets (7 ADC drugs, 4 GNC platform drugs, and 1 bispecific antibody), 2 assets in the IND application stage (1 ADC drug and 1 ARC drug), and a series of preclinical innovative drug candidates. Biokin is currently conducting close to 90 clinical trials, with nearly 80 ongoing in China and 10 in the United States.

This extensive clinical development requires substantial financial resources. According to its third-quarter 2025 report, Biokin's R&D expenditure for the first three quarters reached RMB 1.772 billion, a year-on-year increase of 90.23%. This translates to an average daily R&D "burn rate" of approximately RMB 6.5 million.

However, Biokin is not expected to face significant short-term funding challenges. Its Q3 2025 report shows a net cash inflow of RMB 5.226 billion from financing activities in the first three quarters. This includes RMB 3.731 billion raised through a private placement of A-shares completed in September, with participation from 18 institutional investors including ICBC UBS and CUAM, as well as RMB 2.252 billion in proceeds from borrowings. By the end of the third quarter, Biokin's cash and cash equivalents had increased to RMB 6.086 billion, with net assets reaching RMB 7.171 billion, an 84.5% growth compared to the end of the previous year, marking the highest level in the company's history. Given an estimated semiannual cash consumption of around RMB 1.2 billion, the company's current cash runway is approximately 3 years.

Despite holding billions in cash, innovative drug companies typically have a strong demand for capital until their products generate substantial revenue. During the 2025 semi-annual earnings briefing held in August 2025, Chairman Dr. Yi Zhu stated, "Biokin's clinical development capabilities in China have been validated, and its clinical development capabilities in the U.S. are now established but need to scale up. Furthermore, future global product commercialization capabilities will require both time and financial support."

Regarding its future development, Biokin has a clear strategic plan. During the 2025 semi-annual earnings briefing, Dr. Zhu disclosed, "From 2025 to 2029, Biokin's strategy and path are well-defined. Our goal is to become a leading emerging multinational pharmaceutical company (MNC) in the field of oncology treatment within five years." With the support of time and capital, the emergence of a globally competitive MNC originating from Sichuan, China, is highly anticipated.