According to the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China and public information, this week (April 14 ~ April 19), 10 Class 1 innovative drugs have obtained implied approval (IND) for clinical trials in China for the first time. These products cover small molecules, antibody-drug conjugates (ADCs), gene therapies, cell therapies and other types, and the proposed indications cover advanced solid tumors, type 1 diabetes, spinal cord injury, as well as Duchenne muscular dystrophy (DMD), paroxysmal nocturnal hemoglobinuria, etc.

Hansoh Pharmaceutical (03692): HS-10529 tablets

Mechanism of action: KRAS G12D small molecule inhibitor

Indications: Advanced solid tumors with KRAS G12D mutations

Hansoh Pharmaceutical's Class 1 new drug HS-10529 tablets was approved for clinical trial, and it is planned to develop and treat advanced solid tumors with KRAS G12D mutation (pancreatic cancer, colorectal cancer, non-small cell lung cancer, etc.). According to a press release from Hansoh Pharmaceuticals, this is a small molecule inhibitor developed by the company targeting KRAS G12D, which is highly selective. Preclinical efficacy trials have shown that HS-10529 has good preclinical pharmacodynamic activity, pharmacokinetic profile and safety profile.

In addition, Hansoh Pharmaceuticals has two other Category 1 new drugs approved for IND in China for the first time this week, but the specific mechanism of action of the product has not yet been inquired from public channels. They are: HS-20118 tablets, which are intended to be developed for the treatment of moderate to severe plaque psoriasis; HS-10542 capsules, to be developed for the treatment of paroxysmal nocturnal hemoglobinuria.

Kanghong Biotechnology (002773.SZ): KH815 for injection

Mechanism of action: TROP2 targets dual-payload ADCs

Indications: Advanced solid tumors

Kanghong Pharmaceutical's Class 1 new drug KH815 for injection was approved for clinical trial, and it is planned to develop for the treatment of advanced solid tumors. According to public information, this is a novel dual-payload antibody drug conjugate (ADC) targeting TROP2 with anti-drug resistance potential, consisting of a humanized IgG1 antibody (hRS7) that directly targets TROP2 and binds topoisomerase I inhibitor (TOP1i) and RNA polymerase II inhibitor (RNA POL IIi). The double payload of KH815 enables it to simultaneously inhibit RNA synthesis and induce DNA double-strand breaks, with a dual-effect synergistic mechanism. In addition, it can also reduce the expression of P-gp and HSP70 proteins, overcome drug resistance, and increase the sensitivity of cells to chemotherapy drugs. The product was approved for a Phase 1 clinical study in Australia in March this year.

Innovent (01801): IBI3020

Mechanism of action: CEACAM5 targeting dual-payload ADCs

Indications: Advanced or metastatic solid tumors

Innovent Biologics' Category 1 new drug IBI3020 approved for clinical trial and is intended to be developed for the treatment of unresectable, locally advanced or metastatic solid tumors. According to Innovent Biologics, this is a dual-payload ADC targeting CEACAM5. The product has already shown efficacy in Dxd-resistant tumor models, and Innovent intends to develop the product for the treatment of solid tumors such as bowel cancer and non-squamous non-small cell lung cancer.

Belief Pharmaceutical: BBM-D101 injection

Mechanism of action: AAV gene therapy drugs

Indications: DMD

Belief BioMed's Category 1 new drug BBM-D101 injection has been approved for clinical trial to develop the treatment of Duchenne muscular dystrophy (DMD). According to a press release from Belief BioMed, this is an adeno-associated virus (AAV) gene therapy drug. Through a single intravenous infusion, the optimized gene expression cassette is delivered to the muscles of the whole body based on the engineered AAV vector, in order to achieve "one-dose, long-term efficacy" for the treatment of DMD. The product uses an engineered capsid with higher muscle tissue delivery efficiency and lower clinically intended dose, which is expected to have a good safety profile. The approved clinical study aims to evaluate the safety and efficacy of intravenous infusion of BBM-D101 injection in 4~9-year-old boys with DMD.

Zhixin Haozheng: Allogeneic human regeneration islet injection (E-islet 01).

Mechanism of action: allogeneic universal regenerative islet product

Indications: Type 1 diabetes mellitus

According to the press release of Zhixin Haozheng, E-islet 01 is an allogeneic universal regenerative islet product, which is a regenerative islet that uses cutting-edge technologies such as cell reprogramming and directional differentiation to transform healthy donor-derived blood cells into endoderm stem cells, and then uses endoderm stem cells as raw materials to prepare regenerated islets, which has the same structure and function as healthy islets, and can accurately secrete a series of endocrine hormones including insulin, glucagon, somatostatin and a series of endocrine hormones through real-time perception of blood sugar changes, so as to maintain blood sugar homeostasis. The indication of this product approved for clinical trial is type 1 diabetes.

XellBio: XS228 cell injection

Mechanism of action: Universal iPSC-derived subtype neural progenitor cell injection

Indications: Subacute spinal cord injury (SCI).

XellBio's Class 1 new drug XS228 Cell Injection was approved for clinical trial and is planned to be developed for the treatment of subacute spinal cord injury (SCI). According to the public information of XellBio, this is a general-purpose iPSC-derived subtype neural precursor cell injection developed by XellBio. The drug has been approved for clinical trials in the United States in February this year for the indication of "ALS" (amyotrophic lateral sclerosis/ALS).

Baili Pharmaceutical (688506.SH): BL-M09D1 for injection

Mechanism of action: ADC

Indications: Locally advanced or metastatic solid tumors

According to the announcement of Baili Tianheng, BL-M09D1 is an ADC drug, which is derived from the same small molecule technology platform as BL-B01D1 (EGFR×HER3 bispecific antibody ADC) and shares the same "linker + toxin" platform, and its indication is advanced solid tumors.

Humanwell Innovative Drug R&D Center (600079.SH): HWS116 injection

Mechanism of action: Class 1 new drug of biological products

Indications: Advanced solid tumors

HWS116 injection, a Class 1 new drug of Humanwell Pharmaceutical, was approved for clinical trial and is planned to be developed for the treatment of advanced solid tumors. At present, the specific mechanism of action of this product has not been inquired from public channels, and it can be seen from the acceptance number that this is a class 1 new drug of biological products.

This article is transferred from the WeChat public account of "Pharmaceutical Guanlan", edited by Zhitong Finance and Economics: Song Zhiying.