NMPA Grants 49 New Drug Approvals: Qilu Pharma, CSPC, Eli Lilly, Roche Among Key Players

Dec 24, 2024 09:05 CST Updated 09:06

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NMPA Releases Information on Delivery of Drug Approval Documents on December 23, 2024This batch has 49 approval numbers granted., wherein:

Baoyuan Bio's Adipic Acid Tarextumab Capsule Approved for Marketing，For adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after ROS1-TKI treatment.。

Qilu Pharmaceutical and Chia Tai Tianqing’s Pertuzumab Injection Approved for Marketing on the Same Day，For the treatment of HER2-positive breast cancer。

Pertuzumab is a recombinant humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2),The original product, developed by Roche, has been approved in China for adjuvant treatment of HER2-positive early breast cancer patients at high risk of recurrence. It is also approved for neoadjuvant treatment in combination with chemotherapy and another HER2-targeted monoclonal antibody, trastuzumab, for HER2-positive, locally advanced, inflammatory, or early breast cancer patients.

Chengdu Kangnuo Hang Biological ApplicationPucibay antibody injection new indications approved for marketing, Indications have not been disclosed. In September this year, the product was approved for the first time to treat adult patients with moderate to severe atopic dermatitis who are not well-controlled by topical medications or are unsuitable for such treatments.

Sipuleucel-T Injection is a monoclonal antibody drug targeting IL-4Rα. By blocking the binding of IL-4 and IL-13 to the IL-4Rα receptor, it inhibits the release of downstream inflammatory factors, protein expression, and inflammatory cell activity induced by IL-4 and IL-13, treating atopic dermatitis triggered by excessive inflammatory response.

Eli Lilly's Donanemab Injection Approved for Marketing，For the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease in adults.

Roche's Motuzumab Injection Approved for Marketing，For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Motuzumab is a CD20/CD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects the patient's existing T cells, eliminating malignant B cells by releasing cytotoxic proteins into them.

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