10 new drugs of a certain type approved for clinical trials in China for the first time! From HANSOH PHARMA (03692) and others

According to the official website of the China National Medical Products Administration's Center for Drug Evaluation (CDE) and public information, this week (April 14th to April 19th), 10 first-class innovative drugs in China obtained Investigational New Drug (IND) approval for clinical trials for the first time. These products cover small molecules, Antibody Drug Conjugates (ADC), gene therapy, cell therapy, and so on, with intended indications covering late-stage solid tumors, type 1 diabetes, spinal cord injury, Duchenne muscular dystrophy (DMD), paroxysmal nocturnal hemoglobinuria (PNH), and more. HANSOH PHARMA (03692): HS-10529 tablet Mechanism of action: KRAS G12D small molecule inhibitor Indication: Late-stage solid tumors with KRAS G12D mutation HANSOH PHARMA's first-class new drug HS-10529 tablets have been approved for clinical trials in China, aiming to develop treatments for late-stage solid tumors with KRAS G12D mutation (pancreatic cancer, colorectal cancer, non-small cell lung cancer, etc.). According to HANSOH PHARMA's press release, this is a highly selective small molecule inhibitor targeting KRAS G12D developed by the company. Preclinical efficacy studies have shown that HS-10529 has good preclinical efficacy, pharmacokinetic characteristics, and safety. In addition, HANSOH PHARMA has also obtained IND approval for two other first-class new drugs in China this week, but the specific mechanisms of action of these products have not been found through public channels. They are: HS-20118 tablets, intended for the treatment of moderate to severe plaque psoriasis; HS-10542 capsules, intended for the treatment of paroxysmal nocturnal hemoglobinuria. Kanghong Biotech (002773.SZ): Injection KH815 Mechanism of action: TROP2-targeted dual-payload ADC Indication: Late-stage solid tumors Chengdu Kanghong Pharmaceutical Group's first-class new drug injection KH815 has been approved for clinical trials, aiming to develop treatments for late-stage solid tumors. Public information shows that this is a novel dual-payload Antibody Drug Conjugate (ADC) targeting TROP2 with potential anti-resistance properties. The ADC is composed of a humanized IgG1 antibody (hRS7) directly targeting TROP2, combined with topoisomerase I inhibitor (TOP1i) and RNA polymerase II inhibitor (RNA POL IIi). The dual payload of KH815 allows it to simultaneously inhibit RNA synthesis and induce DNA double-strand breaks, with a dual synergistic mechanism. In addition, it can reduce the expression of P-gp and HSP70 proteins, overcome resistance, and increase sensitivity to chemotherapy. The product received approval for Phase 1 clinical research in Australia in March of this year. INNOVENT BIO (01801): IBI3020 Mechanism of action: CEACAM5-targeted dual-payload ADC Indication: Late-stage or metastatic solid tumors INNOVENT BIO's first-class new drug IBI3020 has been approved for clinical trials, aiming to develop treatments for unresectable, locally advanced, or metastatic solid tumors. According to INNOVENT BIO's public information, this is a dual-payload ADC targeting CEACAM5. The product has shown efficacy in Dxd-resistant tumor models, and INNOVENT BIO plans to develop the product for the treatment of colorectal cancer and non-squamous non-small cell lung cancer, among other solid tumors. Belief Pharmaceutical: BBM-D101 injection Mechanism of action: AAV gene therapy drug Indication: DMD Belief Pharmaceutical's first-class new drug BBM-D101 injection has been approved for clinical trials, aiming to develop treatments for Duchenne muscular dystrophy (DMD). According to Belief Pharmaceutical's press release, this is an adeno-associated virus (AAV) gene therapy drug. Through a single intravenous infusion, the optimized gene expression cassette delivered to the whole body muscles via engineered AAV vectors aims to achieve "one-time dosing, long-term efficacy" in treating DMD. The product uses engineered capsids, with higher muscle tissue delivery efficiency, lower planned clinical doses, and expected good safety. The approved clinical study aims to evaluate the safety and efficacy of intravenous infusion of BBM-D101 injection in boys aged 4 to 9 with DMD. Zhixin Haozheng: Allogeneic Regenerated Islet Injection (E-islet 01) Mechanism of action: Allogeneic universal regenerated islet product Indication: Type 1 diabetes According to Zhixin Haozheng's press release, E-islet 01 is an allogeneic universal regenerated islet product, which uses cutting-edge technologies such as cell reprogramming and directed differentiation to convert blood cells from healthy donor sources into induced pluripotent stem cells, and then manufactures regenerated islets directed from these cells. It has a consistent structure and function with healthy islets, and can accurately secrete a series of endocrine hormones including insulin, glucagon, somatostatin, etc., in response to real-time changes in blood sugar to maintain blood sugar homeostasis. The indication for this product approved for clinical trials is type 1 diabetes. Shize Biotech: XS228 Cell Injection Mechanism of action: Allogeneic iPSC-derived subtype neural precursor cell injection Indication: Subacute spinal cord injury (SCI) Shize Biotechnology's first-class new drug XS228 cell injection has been approved for clinical trials, aiming to develop treatments for subacute spinal cord injury (SCI). According to Shize Biotech's public information, this is a universal iPSC-derived subtype neural precursor cell injection developed by the company. The drug has already been approved for clinical trials in the United States in February of this year, with the indication of amyotrophic lateral sclerosis (ALS). Baili Pharmaceutical (688506.SH): Injection BL-M09D1 Mechanism of action: ADC Indication: Locally advanced or metastatic solid tumors According to Sichuan Biokin Pharmaceutical's announcement, BL-M09D1 is an ADC drug, which is from the same small molecule technology platform as BL-B01D1 (EGFRHER3 dual-antibody ADC) and shares the same "linker+toxin" platform. Its indication is advancedSolid tumor.Humanwell Innovation Drug Research Center (600079.SH): HWS116 Injection Mechanism of action: Class 1 biopharmaceutical Indication: Late-stage solid tumors Humanwell Healthcare's Class 1 new drug HWS116 injection has been approved for clinical use, intended for the treatment of late-stage solid tumors. The specific mechanism of action of this product has not been found from public sources yet, but it is known from the acceptance number that this is a Class 1 biopharmaceutical new drug. This article is taken from the "Medical Observation" WeChat public account, edited by GMTEight: Song Zhiying.