Global First-in-Class CD38 Monoclonal Antibody Generates $3.237 Billion in Q1 2025; Nine Chinese Companies Advance Domestic Pipeline

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The oncology product line achieved a year-on-year sales growth of nearly 18% in Q1 of Year 25, reaching $5.68 billion. Among them,The BCMA CAR-T cell therapy product CARVYKTI, developed in collaboration with Legend Biotech, achieved sales of $369 million in Q1 of 2025, slightly exceeding the expected value of $324 million.

Additionally, the sales of Darzalex (daratumumab, CD38 monoclonal antibody) increased by 20% year-over-year. Darzalex, a multiple myeloma treatment drug launched in 2015, achieved $3.237 billion in sales in Q1 of 2025, surpassing the analysts' expected $3.05 billion.

According to the PharmaOcean database, there are currently three CD38-targeted drugs on the global market. Apart from daratumumab, the world's first approved drug, there is also Sanofi's isatuximab, which is also indicated for multiple myeloma. The last one is daratumumab hyaluronidase, still an original drug developed by Janssen Pharmaceuticals.

Global R&D Status of CD38 Antibodies (Source: PharmaCube Database)

In addition to the three marketed drugs targeting CD38, there are also many companies with drugs in development.There are 9 companies under research and development in China., respectivelyTianjing Biotechnology (Shanghai) Co., Ltd.,HenliusShangjian Biotech,Connem Biotech,SinoCells Biotech,Tianstone Biopharma,Zhengda Tianqing,Ruiyang Bio andNon-Homologous Biosciences.Among them, the fastest progressing in research and development is Fazelimab, jointly developed by Biogen and Tianjing Biotechnology (Shanghai) Co., Ltd.In December 2024, Tianjing Biotechnology (Shanghai) Co., Ltd. submitted a new drug application for Fizetuzumab to treat multiple myeloma, which was accepted by the National Medical Products Administration (NMPA). On April 7 this year, Tianjing Biotechnology announced a collaboration with Biogen regarding two Phase III registrational clinical trials of Fizetuzumab in China, jointly advancing the treatment of IgA nephropathy (IgAN) and primary membranous nephropathy.

Fizetumab was initially developed by MorphoSys AG (now MorphoSys GmbH under Novartis),Tianjing BiotechnologyHolds the exclusive rights for the development and commercialization of Fizetuzumab in all indications across Greater China (including mainland China, Taiwan, Hong Kong, and Macau). HI-Bio has obtained the rights for the development and commercialization of Fizetuzumab in regions outside of Greater China globally. July 2024,BiogenAcquired HI-Bio.

References:

Company Financial Report

PharmCube Cloud Database

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