MSD's Nine-Valent Vaccine New Indication Approved for Marketing in China
Today, MSD's Nine-Valent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)-V503 (Trade name: Gardasil)®9) Approved for a new indication in China, for the prevention of human papillomavirus (HPV) infection in males.'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Image Source: Corporate Official Website
Public information shows that Gardasil®9 is currently the only approved nine-valent HPV vaccine worldwide. It was first approved by the FDA in 2014 and has since been actively expanding into new indications. In April 2018, Gardasil®9 was approved for the first time in China, expanding the target population from initially females aged 16-26 to females aged 9-45. In January 2024, it received NMPA approval for a new two-dose vaccination schedule applicable to females aged 9-14.Image Source: Insight Database
According to statistics, there are currently seven companies in China that have entered the nine-valent HPV vaccine market. Among them, Wantai Bio is the most advanced, being in the application stage for market approval. Four other companies have entered Phase III clinical trials, namely Kangcun Hui, CanSino Biologics, Recbio, and Walvax Biotechnology, while Zhonghui Yuantong Bio is in Phase I/II clinical trials. Additionally, Jiangsu Recbio also has a recombinant nine-valent HPV vaccine - REC604b in the preclinical stage.MSD's Cholesterol-Lowering Drug Approved for Marketing in China
Today, according to the approval information released on the NMPA's official website, Kowa Company's (Kowa Pharmaceutical) newly developed drug Pemafibrate Tablets has been officially approved in China. The approved indication for this drug is the treatment of dyslipidemia.Image Source: NMPA Official Website
Public information shows that pemafibrate (Chinese code K877, English trade name Parmodia) is a new type of peroxisome proliferator-activated receptor (PPAR) α agonist. In terms of mechanism of action, it reduces plasma triglyceride (TG) levels and increases high-density lipoprotein cholesterol (HDL-C) levels by binding to PPARα and regulating the expression of genes involved in lipid metabolism, thereby achieving lipid-lowering effects. Previously, pemafibrate has been approved in Japan for the treatment of hyperlipidemia (including familial hyperlipidemia).Amgen's Bispecific Antibody Phase III Clinical Trial Meets Primary Endpoint
Recently, Amgen announced that the DLL3/CD3 bispecific antibody Tarlatamab (brand name: Imdelltra) met the primary endpoint in the Phase III DeLLphi-304 study. The study included patients with extensive-stage small cell lung cancer (ES-SCLC) who progressed after frontline platinum-based chemotherapy. Compared with standard-of-care (SOC) chemotherapy, Tarlatamab significantly extended overall survival (OS) with statistical and clinical significance. The safety data were consistent with previous studies, with no new safety signals identified.Image Source: Company Official Website
Public data shows that Tarlatamab received accelerated FDA approval in May 2024 for the treatment of ES-SCLC that has progressed after platinum-based chemotherapy, becoming the world’s first bispecific antibody drug targeting DLL3. Its indications have now been expanded to include first-line maintenance therapy (DeLLphi-305 study), comparing the efficacy of Tarlatamab + durvalumab versus durvalumab monotherapy in patients who have not progressed. First-line treatment in combination with chemotherapy (DeLLphi-303 Phase Ib study) is also being explored to evaluate the efficacy and safety of the combination with SOC.In 2024, the global sales of Tarlatamab reached $115 million, with an estimated peak of $1.5-2 billion after indication expansion.Editor: Li Yongshi
Layout Editor: Yu Yuanze
Reviewed by: Ma Fei, Zhang Song
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