Four New Drugs/Therapies Approved in China: Serplulimab, Brigatinib, Bivalent HPV Vaccine, and Novartis Dual-Target Regimen

According to the latest news on the NMPA official website, four new drugs/therapies have been approved for marketing in China. They are Henlius' anti-PD-1 monoclonal antibody Serplulimab Injection, Takeda's next-generation ALK inhibitor Brigatinib Tablets, Walvax Biotechnology's bivalent HPV vaccine "Recombinant Human Papillomavirus Bivalent (16/18) Vaccine (Yeast)," and a new indication for Novartis' dual-target combination therapy.

Henlius: Anti-PD-1 Monoclonal Antibody Serplulimab Injection

NMPA Latest Announcement: Henlius' Anti-PD-1 Monoclonal Antibody Serplulimab Injection Approved for First Indication – Unresectable or Metastatic High Microsatellite Instability (MSI-H) Solid Tumors After Standard Treatment Failure.

Sulrilimab (HLX10) is an innovative anti-PD-1 monoclonal antibody developed by Henlius, which is expected to be used as a single agent or in combination with other products for immunotherapy widely applied in the treatment of solid tumors. In preclinical and early clinical studies, this product has demonstrated favorable PK, PD data, as well as good safety, tolerability, and anti-tumor activity.

Takeda: The Next Generation ALK Inhibitor Brigatinib Tablets

NMPA Latest Announcement: Takeda's New Drug Application for ALK Inhibitor Brigatinib Approved

Public data shows that brigatinib, a new generation TKI developed by ARIAD Pharmaceuticals (acquired by Takeda in February 2017), was designed to specifically target and inhibit ALK fusion proteins. Non-small cell lung cancer is the most common type of lung cancer. Studies have shown that approximately 3% to 5% of non-small cell lung cancer cases are ALK-positive.

In these tumors, the ALK gene in patients often fuses with other genes to produce ALK fusion proteins, a mutation that leads to tumor growth. As a potent ALK inhibitor, brigatinib can inhibit both ALK and ALK fusion proteins, thereby suppressing tumor growth.

Walvax Bio: Recombinant Human Papillomavirus Bivalent (16/18) Vaccine (Yeast)

NMPA Latest Announcement: Walvax Biotech's Controlling Subsidiary, Shanghai Zerun Biotechnology Co., Ltd. (hereinafter referred to as Zerun Bio), has received approval for the market launch of its self-developed "Recombinant Human Papillomavirus Bivalent (16/18) Vaccine (Yeast)." Public information indicates that this bivalent HPV vaccine is primarily used to prevent cervical cancer and precancerous lesions caused by HPV 16/18 infections, available in two formulations: pre-filled syringes and vials.

Scientific research shows that the human papillomavirus (HPV) is a non-enveloped, double-stranded circular DNA virus. When the virus enters a patient's cells through certain pathways, its DNA is released and integrates into the nuclear genome of the host cell, triggering cancer. The NMPA once issued an announcement stating that the HPV vaccine is the world's first vaccine used for cancer prevention, marking humanity’s first attempt to eliminate a type of cancer through vaccination. This vaccine utilizes a specific protein shell from the virus to stimulate the human immune response.

Novartis: New Indication for Dual-Target Combination Therapy

NMPA Latest Announcement: Novartis' New Indication Application for the Combination Therapy of Dabrafenib and Trametinib Approved. According to the priority review announcement, the approved indication for this combination therapy is: for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who are positive for the BRAF V600 mutation.

Public information shows that dabrafenib and trametinib target different kinases in the serine/threonine kinase family within the RAS/RAF/MEK/ERK pathway — BRAF and MEK1/2, respectively. These kinases are commonly present in cancers such as non-small cell lung cancer and melanoma. When used together, the two drugs can simultaneously inhibit both BRAF and MEK, and their effect in slowing tumor growth has been proven to be better than when either drug is used alone.

Editor: Eight Corners

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