Henlius PD-1 was launched this week, becoming the 7th China-made PD-1 monoclonal antibody and the 13th PD-1/PD-L1 monoclonal antibody that was marketed in China. The pharma news review of this week covers a total of 18 news in 3 sections, i.e. review approval, R&D, and listing.
Review Approval
NMPA
Marketing
1. On March 21, it was shown on the CDE official website that Trastuzumab Deruxtecan for Injection (DS-8201) from Daiichi Sankyo/AstraZeneca was declared for marketing for the first time. DS-8201 is a HER2-targeting anti-body-drug conjugate (ADC). In March 2019, AstraZeneca signed a global cooperative development and commercialization agreement with Daiichi Sankyo for obtaining the DS-8201 with an initial payment of US$ 1.35 billion + potential milestones of US$ 5.55 billion.
2. On March 22, it was shown on the CDE official website that the Romiplostim for Injection, a biological medicine of Class 3/4 from Qilu Pharma, was declared for marketing. It was originally developed as Romiplostim by Kyowa Kirin. Romiplostim is the second generation of oral TPO-R agonist that has been approved for marketing by the FDA and EMA for the second-line treatment of immune thrombocytopenic purpura.
3. On March 24, an approval document was published by the NMPA official website, saying that the Henlius-made PD-1 monoclonal antibody - Serplulimab - was approved for marketing for the treatment of unresectable or metastatic highly microsatellite unstable (MSI-H) solid tumors that have failed standard therapy. It is the 7th PD-1 monoclonal antibody that was made in China.
4. On March 24, it was shown on the NMPA official website that the recombinant human papillomavirus bivalent (16/18) vaccine made by the Yuxi Zerun Biotechnology, a subsidiary of Walvax, was approved for marketing. The bivalent HPV vaccine can be used for the prevention of cervical cancer caused by HPV 16 and 18 virus infections.
5. On March 24, it was shown on the NMPA official website that the New Drug Application for Brigatinib, an ALK inhibitor, submitted by Takeda has been approved. It is a new generation of potent selective tyrosine kinase inhibitor (TKI) designed to target anaplastic lymphoma kinase (ALK) molecular variation.
6. On March 24, NMPA made the latest announcement that the marketing application for a new indication of the combination therapy of Dabrafenib and Trametinib submitted by Novartis has been approved. According to the public information of priority review, the combination therapy is approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) who are positive for BRAF V600 mutations.
Clinical Trials
7. On March 22, it was publicized on the CDE official website that the SSGJ-617 Injection declared by Sunshine Guojian obtained the implied permission for clinical trials, and the proposed indication is advanced solid tumors. SSGJ-617 is an antagonistic antibody targeting PSGL-1 researched and developed by Verseau Therapeutics, and Sunshine Guojian owns its rights and interests in Greater China.
8. On March 23, it was shown on the CDE official website that a new indication of KL130008 Capsule, a new drug of Class 1 from Sichuan Kelun Biotech, has been approved for clinical application. KL130008 Capsule is an innovative small-molecule JAK inhibitor independently researched and developed by Kelun Pharmaceutical with intellectual property rights and is intended for the treatment of rheumatoid arthritis.
9. On March 23, it was publicized on the CDE official website that the Obicetrapib Tablet declared by New Amsterdam Pharma obtained the implied permission for clinical trials and is intended as adjuvant therapy to diet and MTD lipid-lowering therapy. Obicetrapib is an oral selective cholesteryl ester transfer protein (CETP) inhibitor being researched by New Amsterdam.
Breakthrough Therapy
10. On March 22, it was publicized on the CDE official website that the Alprazolam Inhalation Powder declared by UCB Pharma...
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