Twenty Class 1 Innovative Drugs Receive IND Approval in China, Including Candidates from Hengrui Medicine, Kelun Biotech, and CSPC

▎WuXi AppTec Content Team Report

According to the official website of the Center for Drug Evaluation (CDE) under China's National Medical Products Administration and publicly available information, this week (November 11th to November 17th), there are 20 Class 1 innovative drugs...First IND Approval in China.After sorting, these products coverSmall molecules, mRNA therapeutic vaccines, small nucleic acid drugs, TCR-T cell therapy, bispecific antibodies, antibody-drug conjugates (ADC)Such as, the indications under development cover various types of solid tumors, atopic dermatitis, primary hypertension, weight loss, type 2 diabetes, etc. This article will introduce the basic information of some products based on publicly available data.

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Eccogene: AZD5004 Film-Coated Tablets

Mechanism of Action:Small Molecule GLP-1 Receptor Agonist

Indications: Medium- to long-term weight management, Type 2 Diabetes

Eccogene's Class 1 new drug AZD5004 film-coated tablets for two indicationsApproved for Clinical Use, intended for long-term weight management in overweight or obese adults with at least one obesity-related comorbidity, as well as for the treatment of type 2 diabetes.Public information shows that this isOnce Daily Oral AdministrationSmall Molecule GLP-1 Receptor Agonist,Considered by industry media Endpoints News to be an eagerly anticipated potential blockbusterNext-Generation GLP-1 Therapy。

November 2023, AstraZenecaEccogene Inc. has reached a collaboration with a potential total value exceeding $2 billion.AstraZeneca will obtain exclusive rights to the development and commercialization of ECC5004 for any indication in all regions outside of China.In China, Eccogene and AstraZeneca will collaborate to develop and commercialize ECC5004.。

CSPC: SYS6026 Injection

Mechanism of Action: Bivalent Human Papillomavirus mRNA Therapeutic Vaccine

Indications: HPV 16/18-related high-grade squamous intraepithelial lesion (HSIL)

CSPC's subsidiary Jushi Biologics' Class 1 new drug SYS6026 Injection has been approved for clinical trials, intended for development in treatment.Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) Associated with Human Papillomavirus (HPV) Types 16/18According to the public information from CSPC, this isA therapeutic bivalent messenger RNA (mRNA) vaccine that expresses the E6 and E7 antigens of human papillomavirus types 16 or 18 through mRNA.Induce the body to produce a specific T-cell immune response, thereby eliminating cells infected with the human papillomavirus and blocking the carcinogenic process.

Leaderna: LDR2402 Injection

Mechanism of Action: Small Nucleic Acid Drugs Targeting AGT

Indications: Essential Hypertension

Leaderna's Class 1 New Drug LDR2402 Injection Approved for Clinical Trials, Intended for Development in TreatmentPrimary Hypertension. According to public information from Leaderna, this is aA Novel Small Nucleic Acid Drug Targeting Angiotensinogen (AGT), Developed Based on RNA Interference (RNAi) Technology. Existing preclinical studies have shown that the product is effective in clinical treatment.It is possible to improve patient compliance by extending the dosing interval (once per quarter or semi-annually)., and may bring cardiovascular benefits to hypertensive patients by maintaining 24-hour blood pressure and reducing blood pressure variability.

Laien Bio: GZL-016 Injection

Mechanism of Action: TCR-T Cell Therapy

Indications: Hepatocellular Carcinoma Associated with Hepatitis B Virus

Guangzhou Laien Biological Medicine Co., Ltd.'s New Drug GZL-016 Injection Approved for Clinical Trials, Intended for Development in TreatmentHepatocellular Carcinoma Associated with Hepatitis B VirusAccording to the introduction in the press release from Guangzhou Laien Biological Medicine Co., Ltd., GZL-016 Injection isAn autologous T-cell therapy that uses mRNA encoding to express TCR targeting the hepatitis B virus surface antigen, granting T cells the ability to specifically recognize and kill hepatitis B virus-associated hepatocellular carcinoma.GZL-016 injection, by effectively utilizing the transient expression characteristics of mRNA and combining multiple infusion methods, can not only well control safety but also ensure efficacy. Moreover, patients do not need to undergo lymphodepletion before treatment, which is expected to further improve the safety and accessibility of the medication.

Boehringer Ingelheim: BI 765179 for Injection Powder

Mechanism of Action: CD137×FAP Bispecific Agonist Antibody

Indications: Squamous Cell Carcinoma of the Head and Neck

Boehringer Ingelheim's BI 765179 Injectable Powder Approved for Clinical TrialsIn combination with pembrolizumab for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma with positive PD-L1 expressionAccording to the introduction on Boehringer Ingelheim's official website, BI 765179 is a CD137×FAP bispecific agonist antibody.This product is only effective when combined with CD137 (Also known as 4-1BB)Only when combined with FAP can it act as a CD137 agonist, leading to tumor-restricted activation of tumor-specific CD137+ T cells.. This product is currently undergoing a Phase 1 trial internationally to evaluate its efficacy as a monotherapy and in combination with the anti-PD-1 monoclonal antibody ezabenlimab for the treatment of advanced solid tumors.

BlissBio: BB-1712 for Injection

Mechanism of Action: ADC Targeting B7-H3

Indications: Locally advanced or metastatic solid tumors

According to the press release from BlissBio, BB-1712 is aAn innovative ADC targeting B7-H3 and utilizing Eribulin as the toxin, intended for development in the treatment of various solid tumors.The product has been approved for IND in the United States this October. Preclinical study results have shown good efficacy and safety.

Wanming Saibo Bio: G01 Eye Drops

Mechanism of Action: Novel Human Recombinant Nerve Growth Factor

Indications: Optic nerve damage caused by glaucoma

The IND Application for Wanmingsaibo's First Product, G01 Eye Drops, Receives Clinical Trial Implied Permission for DevelopmentTreatmentOptic Nerve Damage Caused by GlaucomaAccording to the Wanming Saibo press release, the active ingredient in G01 eye dropsNovel Human-derived Recombinant Nerve Growth Factor (rhNGF-V2)It was co-developed with the American company HumanCell, and Wanming Saibo has exclusive commercial development rights for this molecule in Greater China.

Shenzhen Aimi Life Technology Co. Ltd.: AD101 Ointment

Mechanism of Action: Novel Small-Molecule Drug Targeting AhR

Indications: Mild to Moderate Atopic Dermatitis

Shenzhen Aimi Life Technology Co. Ltd. Class 1 New DrugAD101 OintmentApproved for clinical trials in China, intended for development as a treatmentMild to Moderate Atopic Dermatitis。According to the public data from Shenzhen Aimi Life Technology Co. Ltd., AD101 ointmentMainly acts on the clinically proven therapeutic target for inflammatory skin diseases —— aryl hydrocarbon receptor (AhR)., which can efficiently modulate Th2 and Th1 immune responses, and promote the expression of skin barrier function proteins such as FLG. It also acts on other potential targets like the histamine H1 receptor (a traditional target for allergies). In addition, AD101 is derived from the metabolites of human skin commensal microbiota, thus demonstrating good safety and excellent skin compatibility.Has the potential to become a medication for infants and young children.。

Pivot Bio, Jiangsu Nhwa Pharmaceutical Co., Ltd.: NH160030 Tablets

Mechanism of Action: Biased µ-Opioid Receptor Agonist

Indications: Intended for cancer pain

NH160030 Tablets, jointly submitted by Jiangsu Nhwa Pharmaceutical Co., Ltd. and its innovative drug R&D center Shujing Biotech, have been approved for clinical trials and are expected to be developed for cancer pain. According to the announcement by Nhwa Pharmaceutical, NH160030 is aA selective µ-opioid receptor agonist suitable for oral administration, representing a new generation of opioid analgesics.Preclinical studies have shown that, compared to commonly used opioid analgesics such as morphine and oxycodone, it has superior efficacy and fewer side effects.

Kelun-Biotech: MK-6204 for Injection (SKB535), SKB571 for Injection

Mechanism of Action:New Biologics Drug, Bispecific ADC

Indications: Advanced Solid Tumors

Kelun-Biotech’s Two Class 1 New Drugs Granted IND Approval for the First Time in China, Both for TreatmentAdvanced Solid TumorsAmong them, MK-6204 for injection (SKB535) is a Class 1 new biologic drug. The specific mechanism of action of this product has not been found through public channels so far. According to the NMPA official website recently...Public Notice, the product isThe First Clinical Trial Application Approved Under the Pilot Work Program Took Only 21 Days for Review and Approval。

SKB571 is an innovative bispecific antibody-drug conjugate (ADC), primarily targeting various solid tumors such as lung cancer and gastrointestinal tumors.. Through scientifically selected target combinations and a differentiated bispecific antibody molecular design, the product enhances tumor targeting and helps overcome tumor heterogeneity, thereby improving efficacy. By employing a highly hydrophilic toxin-linker strategy, the product demonstrates favorable pharmacokinetic properties. In August this year, Merck exercised its option on the SKB571 project.Exclusive Option, and pay Kelun-Biotech 37.5 million US dollars. Kelun-Biotech will retain the rights to cross-regional development, use, manufacturing, and commercialization of SKB571 in mainland China, Hong Kong, and Macao.

Hengrui Pharma: SHR-3045 Injection

Mechanism of Action:New Biologics Drug

Indications: Rheumatoid Arthritis

Hengrui Pharma's Class 1 New Drug SHR-3045 Injection Approved for Clinical Trials, Intended for Development in TreatmentRheumatoid Arthritis. The mechanism of action of this product has not been found through public channels yet. From the acceptance number, it can be seen that this is a Class 1 biological new drug.

In addition to the aforementioned products, the Class 1 new drugs that received IND approval in China for the first time this week also include:

• Grainstack Biotech's GD-20 Tablets, under development for the treatment of multiple sclerosis;

• CA1001 Injection, filed by Xixiou Ai Bio, is under development for the treatment of acute ischemic stroke.

• AC02 for Injection, filed by Nanjing Hanxin Pharmaceutical Technology, is under development for the treatment of infantile spasms.

• KYHY2302 Cream, jointly filed by Kangyuan Pharmaceutical and Shanghai Institute of Materia Medica, Chinese Academy of Sciences, is under development for the treatment of psoriasis.

• KYHY2303 Tablets, jointly filed by Kangyuan Pharmaceutical and others, are being developed for the treatment of malignant hematological tumors.

• Changtai Pharmaceuticals' PC-0003 Inhalation Solution, intended for development as an adjunctive treatment for asthma patients;

• The NTB-3119M tablet, jointly filed by Qingdao Baiyang Pharmaceutical Co., Ltd. and the Institute of Materia Medica, Chinese Academy of Medical Sciences, is under development for tuberculosis infections, including pulmonary tuberculosis.

• Minghui Pharmaceuticals' MHB118C for Injection, Intended for the Treatment of Advanced Malignant Tumors.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Nov 17，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c