At the end of January 2022, HanBio Therapeutics (Shanghai) Co., Ltd. ("HanBio Therapeutics") announced the completion of a $40 million Series A financing round to advance the preclinical and clinical development of a series of innovative antibody and other biopharmaceutical products with global independent intellectual property rights. This round was co-led by Orbimed Advisors and HanKang Capital, with participation from Yonghua Investment and Licheng Investment. Prior to this financing, HanBio Therapeutics was an early-stage product research and development company incubated by 3SBio Inc. ("3SBio"); at that time, the company's product pipeline included 3 bispecific antibodies in IND and pre-IND stages, as well as various antibodies and other biopharmaceutical products in early research and development stages. The bispecific antibodies were (PD-1/TGFB bispecific antibody, PD-1/LAG-3 bispecific antibody, and PD-1/VEGF bispecific antibody).
On September 7, 2022, 3SBio held the 12th meeting of the 4th Board of Directors and approved the "Announcement on the Termination of Joint Investment with Related Parties and Connected Transactions". The announcement stated that since the signing of the "Series A Preferred Stock Purchase Agreement" at the beginning of the year, 3SBio had actively communicated with all parties and made efforts to promote the relevant closing work. However, since March 2022, due to the impact of factors such as the COVID-19 pandemic, the closing has not been completed. Based on changes in the capital market environment, after communication between investors and 3SBio, 3SBio and the lead investors of the Series A preferred stock intend to terminate this transaction.
On February 20, 2025, 3SBio issued an announcement: To further focus on core advantageous assets, optimize business structure and resource allocation, and accelerate the high-quality development of the company, the company and its wholly-owned subsidiary HanBio Therapeutics intend to sign a "License Agreement" with 3SBio Inc., and plan to exclusively license the company's 612 project and 708 project to Shenyang 3SBio. According to the agreement, 3SBio will receive an initial payment of RMB 102 million from Shenyang 3SBio, as well as milestone payments and 15% of the pipeline sales as subsequent royalties. After that, Shenyang 3SBio can use the licensed patents, licensed technical secrets, and other intellectual property rights in mainland China to research, develop, register, improve, produce, use, sell, offer for sale, export, and import the licensed products for all indications targeting the cooperative targets. The 612 project and 708 project refer to clinical products independently developed by 3SBio. 612 is a new anti-HER2 humanized monoclonal antibody; 708 is a bispecific antibody targeting PD-1/TGF-β.
On May 20, 2025, 3SBio announced that the company, its related party 3SBio Inc., and Shenyang 3SBio Pharmaceutical Co., Ltd. (hereinafter referred to as "Shenyang 3SBio") jointly granted Pfizer the exclusive global (excluding mainland China) rights to develop, produce, and commercialize the PD-1/VEGF bispecific antibody SSGJ-707. Pfizer retains the right to obtain the license to commercialize the product in mainland China by paying additional fees. According to the agreement, Pfizer will pay an upfront payment of $1.25 billion, which is non-refundable and non-deductible, milestone payments of up to $4.8 billion for development, regulatory approval, and sales, as well as tiered sales royalties in double-digit percentages based on the product sales in the authorized regions. SSGJ-707 is a PD-1/VEGF bispecific antibody developed based on the CLF2 patent platform, which can simultaneously inhibit both PD-1 and VEGF targets. Phase II clinical stage analysis data show that SSGJ-707 has achieved excellent objective response rate (ORR) and disease control rate (DCR) in the treatment of non-small cell lung cancer (NSCLC) patients. Whether used as a monotherapy or in combination with chemotherapy, it has demonstrated significant anti-tumor activity and good safety, with the potential to be best-in-class. In April this year, SSGJ-707 received the breakthrough therapy designation from the National Medical Products Administration, with the indication of first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression. Previously, SSGJ-707 had obtained IND approval from the FDA. Currently, the indication of SSGJ-707 as a monotherapy for first-line treatment of non-small cell lung cancer has entered Phase III clinical stage, the indication of combined chemotherapy for first-line treatment of non-small cell lung cancer is in Phase II clinical stage, the indication of metastatic colorectal cancer is in Phase II clinical stage, and the indication of advanced gynecological tumors is in Phase II clinical stage.
