Shanghai Fosun Pharmaceutical (02196): GR1803 Injection has been conditionally approved by the National Medical Products Administration.

date
19:17 27/08/2026
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GMT Eight
Fosun Pharma (02196) announced that on May 28, 2026, Chongqing Yaoyou Pharmaceutical Co., Ltd. (hereinafter referred to as "Yaoyou Pharma"), a controlled subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., signed a licensing agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. (Zhixiang Jintai). The agreement grants Yaoyou Pharma exclusive rights for the clinical development and commercialization of the licensed product (namely, a bispecific antibody drug that targets BCMA and CD3 with GR1803 as the only active ingredient) in mainland China and the Hong Kong, Macau, and Taiwan regions, as well as exclusive rights for research into the production process and manufacturing. Yaoyou Pharma will be the marketing authorization holder (MAH) for the product(s) in the licensed region.
Shanghai Fosun Pharmaceutical (02196) announced that on May 28, 2026, its holding subsidiary, Chongqing Yaoyou Pharmaceutical Co., Ltd. (hereinafter referred to as "Yaoyou Pharmaceutical"), signed a licensing agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. (Zhixiang Jintai). Under this agreement, Yaoyou Pharmaceutical was granted exclusive rights for the clinical development and commercialization of the licensed product (i.e., a bispecific antibody drug with GR1803 as the sole active ingredient and/or designed to target both BCMA and CD3 simultaneously) within China and the Hong Kong, Macau, and Taiwan regions, as well as exclusive rights for research and production processes. Yaoyou Pharmaceutical will serve as the marketing authorization holder (MAH) for the product in the licensed areas. Recently, the GR1803 injection (generic name: Veltuzumab injection; trade name in mainland China:; hereinafter referred to as "the drug") received conditional approval from the National Medical Products Administration. The approved indication is for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously undergone at least three lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody). GR1803 is a bispecific antibody that can simultaneously bind to BCMA and CD3 antigens, thereby redirecting cytotoxic T cells to cells expressing BCMA. In addition to the approved indication, as of the date of this announcement (August 27, 2026, same below), multiple clinical studies for the drug in treating adult relapsed or refractory multiple myeloma, systemic lupus erythematosus, and other conditions are being conducted orderly in mainland China. According to the latest IQVIA MIDAS data, the global sales of BCMACD3 targeted antibody drugs is expected to be approximately $1.139 billion in 2025. As of the date of this announcement, two BCMACD3 targeted antibody drugs have received conditional market approval in mainland China, namely, Pfizer Inc.s Elotuzumab injection (approved in March 2025) and Janssen-Cilag International NVs Teclistamab injection (approved in June 2024). The approval of this drug for market release provides a new treatment option for adult patients with relapsed or refractory multiple myeloma in mainland China and will further enrich the product line of the group (i.e., this company and its holding subsidiaries/units). Moving forward, Yaoyou Pharmaceutical and Zhixiang Jintai will proceed with the transfer of the marketing authorization holder (MAH) as per the agreement.