FOSUN PHARMA (02196.HK): Licensed drug weliteitumab injection (GR1803) granted conditional approval for relapsed or refractory multiple myeloma

NewTimeSpace News: On 27 August 2026, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (stock code: 02196) announced that GR1803 injection (generic name: weliteitumab injection; trade name in China: Weikenuo), licensed to its controlling subsidiary Chongqing Yaoyou Pharmaceutical Co., Ltd., has been granted conditional approval by the National Medical Products Administration (NMPA), for the indication of adult patients with relapsed or refractory multiple myeloma who have previously received at least three lines of therapy (including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody).

According to the announcement, on 28 May 2026, Yaoyou Pharmaceutical entered into a license agreement with Chongqing Zhixiang Jintai Biological Pharmaceutical Co., Ltd., under which Yaoyou was granted the exclusive right to clinically develop and commercialize the licensed product in Mainland China, Hong Kong, Macao and Taiwan, together with the exclusive right to research and produce the manufacturing process, with Yaoyou to serve as the marketing authorization holder (MAH) for the product in the licensed territory. The drug is available in a specification of 20mg (2ml) per vial, with a registration classification of Class 1 therapeutic biologics and an approval number of "Guoyao Zhunzi S20260066".

GR1803 is a bispecific antibody that simultaneously binds to BCMA and CD3 antigens, redirecting cytotoxic T cells to BCMA-expressing cells. In addition to the approved indication, multiple clinical studies of the drug for the treatment of adult relapsed or refractory multiple myeloma and systemic lupus erythematosus are being conducted in Mainland China as of the date of the announcement. According to the latest IQVIA MIDAS data, global sales of BCMA×CD3 targeted antibody drugs in 2025 were approximately USD 1.139 billion; as of the date of the announcement, two similar products have been granted conditional marketing approval in China, namely Pfizer Inc.'s elranatamab injection (approved in March 2025) and Janssen-Cilag International NV's teclistamab injection (approved in June 2024).

The approval provides a new treatment option for adult patients with relapsed or refractory multiple myeloma in China and further enriches the Group's product line; subsequently, Yaoyou Pharmaceutical and Zhixiang Jintai will advance the MAH transfer in accordance with the agreement. The Company cautioned that the specific sales performance of the drug after launch may be affected by factors including drug demand, market competition and sales channels, and is subject to significant uncertainty.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.