Disclaimer: Due to limited expertise, errors are inevitable, and some information may not be the most up-to-date. Feel free to point out in the comments. This article only introduces drugs related to medical health and does not recommend treatment plans (if involved); this article does not constitute any investment advice.
Cell and Gene Therapy (CGT) is a new generation of precision therapy following small-molecule and large-molecule targeted therapies.On November 16, CGT therapy achieved a breakthrough as Casgevy, the world's first CRISPR gene-editing therapy jointly developed by Vertex Pharmaceuticals and CRISPR Therapeutics, received conditional approval for marketing in the UK. It is intended for treating sickle cell disease and transfusion-dependent β-thalassemia.Looking at China, according to incomplete statistics,NovemberA total of 14 CGT therapy INDs have been approved, involving 13 companies including Wanbang Pharmaceuticals, StarCross Bio, Beijing Gene Key Life Technology Co., Ltd, Kairui Bio, FountBio, Dingxin Gene, Baiji Gene, and Shanghai Pharmaceuticals.
On November 21, GKL-006 Injection developed by Beijing Gene Key Life Technology Co., Ltd. received clinical trial implied permission for the treatment of unresectable primary hepatocellular carcinoma. GKL-006 Injection isA Type of iNKT Cell Therapy。On November 21, Kerui Bio's first immunocyte therapeutic product, CRTE7A2-01 TCR-T Cell Injection, received clinical trial approval, marking...KarryBio officially moves to the phase of conducting registration clinical trials.。On November 6, FT-002 Injection, an innovative gene therapy drug independently developed by Fangtuo Bio, received clinical trial approval from the CDE for the treatment of X-linked retinitis pigmentosa (XLRP) caused by RPGR gene mutations.Currently, there is no effective drug for treating XLRP available on the global market, and FT-002 injection is a treatment in the field of XLRP in China.The First to ObtainCDE Clinical Trial Approval and Gene Therapy Drugs for Human TrialsRecently, SCG101 Cell Injection from StarCross Bio has received tacit approval for clinical trials from the China National Medical Products Administration (NMPA) for the treatment of hepatitis B virus-related intrahepatic cholangiocarcinoma.SCG101 Injection is a globally pioneering (First in class) autologous TCR-T cell therapy product.The world's first cell therapy targeting cholangiocarcinoma。Notably, VT-101 Injection, independently developed by Wanbang Medicine, a holding subsidiary of Fosun Pharma, has been approved respectively.National Medical Products AdministrationAndU.S. FDAApproval for the clinical trial of this new drug intended for the treatment of advanced squamous cell carcinoma of the head and neck, melanoma, breast cancer, and other solid tumors.This drug is a triple tumor-targeting regulatory mechanism, with three viral structural gene modifications, three serotypes of adenovirus chimerism, and three types of anti-cancer immune gene loading.New Generation Recombinant Oncolytic Adenovirus ProductAs of October 2023, Fosun Pharma Group's total R&D investment in this new drug has reached approximately 54.5 million yuan.
In addition, in November, 10 CGT therapy INDs were accepted for review, involving 10 companies including Huaxia Yingtai, SinoBio, Zhongyin Technology, Dabo Bio, Bowang Pharma, Jinweike Bio, ImmuneOnco, and Yin Crown Bio.
Among them, HuaXia Ying Tai's "YTS104 Cell Injection," as a STAR-T cell drug developed by Huaxia Ying Tai to explore new targets for hematological tumors, brings new hope for the treatment of indications such as acute myeloid leukemia.ZVS203e Injection, a gene-editing therapeutic drug developed by China-based Beijing Gene Key Life Technology Co., Ltd.It is the first in vivo AAV gene editing therapeutic product accepted in China., used to treat retinitis pigmentosa caused by RHO gene mutations.
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