ZedeMan Pharmaceuticals' Tapinarof Cream, Huadong Medicine's Rilonacept Approved in China; YiMiao Shenzhou Submits NDA for IM19 CAR-T Therapy

Nov 29, 2024 17:19 CST Updated 17:19

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Imunopharm

Developer of Gene and Cell Therapy Technologies

Zedman Medicine's Benvelumod Cream Approved for Marketing

On November 27, the NMPA official website announced that Zedman Pharmaceuticals' TAP-1503 Benvitimod Cream had been approved for marketing in China, for the treatment of patients aged 2 years and above with atopic dermatitis (Acceptance No.: CXHS2300119). The drug was formally included in the priority review in January 2024.

Benvitimod cream is a non-hormonal drug with a novel mechanism of action, targeting AhR. It addresses the challenges of atopic dermatitis from multiple aspects by suppressing inflammation, alleviating oxidative stress, and promoting the restoration of skin barrier function.

As the world's first and only AhR modulator approved for pediatric use, Benvitimod Cream breaks the lower age limit, with an approved age as low as 2 years. According to the official website, Benvitimod Cream takes effect rapidly, providing quick itch relief upon the first application, and shows significant improvement in lesion area and severity during the initial assessment. Moreover, the drug demonstrates excellent efficacy: after 8 weeks of treatment, nearly 70% of pediatric patients achieved over 75% symptom improvement, and it is the first topical medication to perform exceptionally well in achieving near-complete recovery (over 90% improvement).

Huadong Medicine "Linaclotide" Approved for Marketing

On November 27, the NMPA official website announced that Huadong Medicine's "Rilonacept Injection" has been approved for marketing (JXSS2300084) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

According to the Insight database, another indication of this drug was also accepted by the CDE (JXSS2400016) in March this year for Recurrent Pericarditis (RP), and is expected to be approved by Q1 2025.

Rilonacept is a recombinant dimeric fusion protein that blocks the signaling of interleukin-1α (IL-1α) and interleukin-1β (IL-1β). The product was originally developed by Regeneron. In 2017, Kiniksa acquired the rights to injectable Rilonacept from Regeneron; and in February 2022, Huadong Medicine obtained exclusive licenses for the drug in 24 Asia-Pacific countries and regions including China, South Korea, Australia, New Zealand, and India (excluding Japan) from Kiniksa.

Yimiao Shenzhou IM19 Chimeric Antigen Receptor T-Cell Injection Submitted for Market Approval

Recently, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. announced that the marketing application of its first self-developed autologous CAR-T cell candidate product IM19 Chimeric Antigen Receptor T-Cell Injection (IM19), targeting CD19, has been accepted by the NMPA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).

This NDA acceptance is based on an open-label, single-arm, multi-center confirmatory clinical trial conducted in China. The study results showed that IM19 achieved favorable efficacy and safety data in the treatment of r/r DLBCL patients.

IM19 CAR-T Cell Injection is the first self-developed blood cancer CAR-T cell candidate drug by Beijing Yimiaoshenzhou Medical Technology Co., Ltd. It features an innovative CAR molecular design and internationally leading production technology. Three indications have been approved for clinical trials by the NMPA, namely relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), relapsed/refractory acute B lymphoblastic leukemia (r/r B-ALL), and relapsed/refractory mantle cell lymphoma (r/r MCL). All of these have entered the registration clinical research stage.

Editor: Wanwan