Pharmaceutical Approvals Bloom in March: Multiple Companies Announce New Drug Approvals and Clinical Trial Clearances

　　【Pharmaceutical Network Industry Dynamics"As the saying goes, 'The whole year's work depends on a good start in spring.' In the warm and flowery March, the pharmaceutical industry has also ushered in a batch of good news about drugs being approved for marketing or clinical trials. For instance, Antengene and Legend Biotech have successively announced the approval of their drugs for marketing, while a subsidiary of Fosun Pharmaceutical declared that its lymphoma treatment product has been approved for clinical trials."
 

　Antengene Announces XPOVIO(R) Approved for Marketing in Singapore
 

On March 2, Antengene announced that XPOVIO® (selinexor) has been granted marketing authorization by the Health Sciences Authority (HSA) of Singapore for the treatment of three indications: Relapsed/Refractory Multiple Myeloma (R/R MM) – selinexor in combination with bortezomib and dexamethasone for R/R MM patients who have received at least one prior therapy; Relapsed/Refractory Multiple Myeloma (R/R MM) – selinexor in combination with dexamethasone for adult R/R MM patients who have received at least four prior therapies and are refractory to at least two proteasome inhibitors, two immunomodulatory agents, and one anti-CD38 monoclonal antibody; Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) – selinexor monotherapy for adult R/R DLBCL patients who have received at least two prior therapies and are ineligible for hematopoietic stem cell transplantation.
 

　　Legend Biotech's Cilta-cel Approved for Marketing
 

On March 1, Legend Biotech, a U.S.-listed company, announced that the U.S. FDA had approved the Biologics License Application (BLA) for its product cilta-cel (Cilta-cel, research code: LCAR-B38M) for the treatment of adult patients with relapsed/refractory multiple myeloma (MM). Cilta-cel has become an FDA-approved cell therapy product and is also the approved CAR-T cell immunotherapy targeting BCMA.
 

Legend Biotech stated that the approval of Cilta-cel is primarily based on the pivotal phase 1b/2 CARTITUDE-1 clinical study results. The data showed that Cilta-cel achieved an overall response rate as high as 98% in patients with relapsed or refractory multiple myeloma who had previously received four or more lines of therapy (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies).
 

　　Junshi Biosciences' Adalimumab Injection Drug Registration Approved
 

On March 2, Junshi Biosciences announced that according to the inquiry on the website of the National Medical Products Administration (NMPA), the marketing authorization application for the company's Adalimumab Injection (Project Code: UBP1211, Trade Name: Junmaikang®) for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis has entered the "Approval Completed - Pending Certificate Issuance" stage. This indicates that the NMPA has completed the review, and the relevant administrative department is in the process of preparing the drug registration certificate.
 

The announcement shows that in August 2017, Junshi Biosciences entered into a collaboration research, development, and commercialization agreement with Taikang Biologics, a wholly-owned subsidiary of Mabwell Biologics, to jointly develop Junmai KangR and share all related intellectual property rights. In November 2020, Junshi Biosciences, Mabwell Biologics, and Taikang Biologics entered into a supplementary agreement stipulating that after the market launch of Junmai KangR, a joint venture co-invested by the company and Mabwell Biologics would act as the Marketing Authorization Holder (MAH). The profits of the joint venture will be distributed between the company and Mabwell Biologics in a 50:50 ratio. Mabwell Biologics or its holding subsidiary will be responsible for the production and sales of Junmai KangR.
 

　　Fosun Pharmaceutical Subsidiary's Lymphoma Treatment Product Clinical Trial Approved
 

On March 2, Fosun Kite Biotechnology Co., Ltd., a subsidiary of Fosun Pharmaceutical, announced that it had received approval from the National Medical Products Administration to conduct clinical trials of its CD19-targeted autologous CAR-T cell therapy product FKC889 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received two or more prior lines of therapy. As of January this year, Fosun Kite has cumulatively invested RMB 11.92 million in the research and development of this product.
 

Data shows that FKC889 is a CAR-T cell therapy drug introduced by Fosun Kite from Kite Pharma (a Gilead company) for industrialization and commercialization in China. It is Tecartus (brexucabtagene autoleucel), and also the second CAR-T cell therapy drug developed by Fosun Kite in the field of hematological malignancies. FKC889 is a chimeric antigen receptor CAR-T cell therapy, as well as an individualized treatment method that uses the human body's own immune system to target cancer cells.
 

　　Hengrui Medicine: The Company Currently Has 5 ADC Drugs Approved for Clinical Trials
 

On March 1, Hengrui Medicine announced on the investor interaction platform that the company has received clinical approval for a total of five ADC drugs (SHR-A1811, SHR-A1904, SHR-A1912, SHR-A2009, SHR-A1921). Regarding the non-winning bid for ioversol injection, the company will actively promote the sales and marketing of the product through other channels and continue to focus on the sales of similar products.
 

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