This week, the EU officially released the eagerly anticipated final revision of its GMP Annex 1 for sterile drug products. The news review of this week is from August 22 to 26, covering a total of 20 pieces of information on drug review, R&D, business, and policy.
Drug Review
NMPA – Marketing
[Application]
1. On August 23, the CDE official website revealed that the marketing application for the new indication of BeiGene Tislelizumab (brand name: Baizean) was accepted by the NMPA. It is speculated that the new indication is the combination chemotherapy for patients with previously untreated advanced or metastatic esophageal squamous cell carcinoma (ESCC). This is the 11th indication of the product declared for marketing in China, nine indications of which had been approved for marketing in the past.
NMPA – Clinical Trials
[Approval]
2. On August 22, the CDE official website revealed that the clinical trial application for Ascletis’ASC10 was approved. ASC10 is a COVID-19 oral candidate drug polymerase (RdRp) inhibitor developed independently by Ascletis, with a new and differentiated chemical structure compared to its single prodrug, molnupiravir. On August 3, ASC10 was approved by the FDA for a Phase Ib clinical trial in patients with mild to moderate COVID-19.
3. On August 22, Shanghai Pharma announced that its B013 injection was approved by the NMPA for Phase II clinical trials. The indications are the first-line treatment of locally advanced or metastatic triple-negative breast cancer. B013 injection is a novel human recombinant monoclonal antibody product. Shanghai Pharma signed and entered into the license agreement with Oncternal and received the exclusive rights in Greater China in September 2018.
4. On August 23, the CDE revealed that the fourth-generation EGFR inhibitor of Qilu Pharmaceutical, QLH11811, was approved for clinical use. Its indication is the advanced NSCLC with EGFR and other driver gene abnormalities. QLH11811 shows better activity than the third-generation inhibitor, osimertinib, in the wild-type EGFR, the activating mutation ex19del, and the multiple combinatorial resistance mutations, and especially has the highest activity against the L858R/C797S ...
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