Seven Class 1 Innovative Drugs Receive First-in-China IND Approvals from Companies Including Qilu Pharmaceutical and BeiGene

Jul 21, 2024 08:20 CST Updated 08:20

Qilu Pharmaceutical

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According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China and publicly available information, this week there are7 Products1First-in-class innovative drug receives clinical trial implied permission in China for the first time。These products coverMonoclonal antibodies, trispecific antibodies, antibody-drug conjugates (ADC), mRNA cancer vaccines, cell therapy productsAnd many other types, with indications covering various types of cancers, tetanus, weight management, and more. This article will introduce the information about these products based on publicly available data.

Qilu Pharmaceutical: QLS4131 for Injection

Mechanism of Action: Tri-specific Antibody

Indications:Multiple Myeloma

Qilu Pharmaceutical's Class 1 new drug, QLS4131 for injection, has been approved for clinical trials and is intended for the development of treatment for multiple myeloma.This is the first time that the product has been approved for clinical use in China. According toClinicalTrialsOfficial website information,QLS4131 is a trispecific humanized antibody.Qilu Pharmaceutical has registered a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLS4131 in treating relapsed or refractory multiple myeloma. The study is planned to be conducted in China, with an expected start date of August 30 this year, lasting for 2 years.

Shenzhen Xiling Biopharmaceutical Technology Co., Ltd.: CEL001 Injection

Mechanism of Action: New Biologics

Indications: Advanced Solid Tumors

Shenzhen Xiling Biopharmaceutical Technology Co., Ltd.'s CEL001 Injection Approved for Clinical Use, Intended for the Treatment of Advanced Solid Tumors. According to publicly available information, this is aOff-the-shelf NK cell candidate productPublic information shows that Xiling Bio hopes to develop breakthrough new therapies for malignant solid tumors, and its product pipeline involvesResearch on Tumor and Immune Mechanisms, Efficient Expansion of "Off-the-Shelf" Immune Cell DrugsIn multiple fields. In May this year, the company also announced the completion of a multi-million yuan Pre-A round of financing exclusively invested by Sai Ma Capital.

MaxThink Biotech: Injectable CB-002

Mechanism of Action: Biologics

Indications: Advanced Solid Tumors

MaikeSi Bio's Class 1 new drug, CB-002 for injection, has been approved for clinical trials, intended for the development of treatment for advanced solid tumors. According to the application number (CXSL2400297), this is a therapeutic biological product, and this marks the first time the product has been approved for clinical trials in China.

Lanzhou Institute of Biological Products: Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection

Mechanism of Action:Anti-tetanus Toxin Monoclonal Antibody

Indications: Prevention of tetanus

Lanzhou Institute of Biological Products' Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Product Approved for Clinical TrialsIntended for the prevention of tetanus, especially suitable for patients who have allergic reactions to tetanus antitoxin (TAT).Currently, the passive immunization agents used clinically for the prevention and treatment of tetanus mainly include TAT and human tetanus immunoglobulin (HTIG). TAT often has a higher incidence of allergic reactions, while HTIG has limitations such as associated risks and source shortages. According to the press release from the Lanzhou Institute of Biological Products, the monoclonal antibody product for tetanus passive immunization that has been approved for clinical trials by the company was obtained through genetic engineering technology. It has high purity, low impurity, and is suitable for large-scale production.

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Suzhou Alphamab: KN069 Injection

Mechanism of Action: GLP-1 Variant/GIPR Single-Domain Antibody Fc Fusion Bifunctional Protein

Indications: Weight Management

KN069 Injection, a Class 1 new drug developed by Suzhou Alphamab, has been approved for clinical trials and is suitable forWeight Management for Obese Patients or Overweight Patients with at Least One Comorbidity.According to the press release from Suzhou Alphamab, KN069 is a self-developed product of the company.Recombinant Human GLP-1 Variant/GIPR Humanized Single-Domain Antibody Fc Fusion Bifunctional Protein. The product simultaneously hasGLP-1 Receptor AgonistActivity andGIPR AntagonistActivity, the synergistic effect of which has the function of reducing weight and blood sugar, thus showing broad application potential in the field of metabolic diseases such as obesity and diabetes.

Suzhou Alphamab has previously reached an agreement with Amoytop Biotech for a biologic drug.Authorization Cooperation, granting the rights to develop NASH indications for KN069 and another innovative biologic in mainland China to Amoytop Biotech.

BeiGene: BG-C9074 for Injection

Mechanism of Action:ADC Targeting B7H4

Indications: Advanced Solid Tumors

BeiGene's Category 1 New Drug for InjectionBG-C9074Approved for Clinical Use, Intended to develop treatment forAdvanced Solid Tumors. According to public information, this is aAntibody-Drug Conjugates (ADC) Targeting B7H4BeiGene reached an agreement with Duality Bio in July 2023.Over 1.3 Billion USDThe cooperation, thereby obtaining the ADC productGlobal Development and Commercialization Rights。

AFNA Biotech, Anke Biotech: AFN0328 Injection

Mechanism of Action: mRNA Cancer Vaccine

Indications: HPV16/18 infection

AFN0328 Injection, a Class 1 new drug jointly developed by Afana Bio and Anke Bio, has been approved for clinical trials and is proposed for development to treatHPV16/18 infection-related cervical intraepithelial neoplasia, genital or vaginal intraepithelial lesions, cervical cancer, anal cancer, vulvar cancer, vaginal cancer, penile cancer, and head and neck cancer, etc. Public information shows that this is an mRNA therapeutic vaccine for HPV-related tumors. It adopts a unique adjuvant system and innovative antigen design, which can effectively present antigens in primates.

In addition to the aforementioned products, other Class 1 new drugs have recently received implied permission for clinical trials. Due to space limitations, this article will not introduce them one by one. It is hoped that the subsequent research of these investigational new drugs will proceed smoothly, achieving breakthroughs as soon as possible to bring new treatment options to patients.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved July 21，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Official websites of various companies and publicly available information

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