Yue Xiang Yue Health Submits IPO Filing in July 2024

Recently, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human GPRC5D-targeted Chimeric Antigen Receptor T-cell (CAR-T cell) injection (research code: RD118) has received tacit approval from the National Medical Products Administration (NMPA) for the proposed treatment of relapsed/refractory multiple myeloma (RRMM).

On July 24, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Equecabtagene Autoleucel Injection) has received tacit approval from the U.S. Food and Drug Administration (FDA) for the proposed treatment of multiple sclerosis. This marks the second autoimmune disease indication for Equecabtagene Autoleucel Injection to successfully gain FDA approval in 2024, following refractory generalized myasthenia gravis (gMG).

On July 25, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human anti-CD19 monoclonal antibody IASO-782 injection has received tacit approval from the National Medical Products Administration (NMPA) for the proposed treatment of Systemic Lupus Erythematosus (SLE).

On July 2, 2024, Biostar announced that the U.S. Phase 2 clinical trial (BG01-2402) of Utidelone Injection for the treatment of HER2-negative breast cancer brain metastases (BCBM), one of its key overseas pipelines, has been approved by the U.S. Food and Drug Administration (FDA).

MingMed Biotechnology Co., Ltd. announced that the first medical indication YY001-002 – adult upper limb muscle spasticity of its self-developed injectable recombinant botulinum toxin type A, which is independently innovated by its holding company Chongqing Yu Yan Pharmaceutical Co., Ltd. and has global intellectual property rights, was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct clinical trials on July 2. This marks an important milestone as the world's first application of recombinant botulinum toxin type A in the medical field.

Bidding data for the first half of 2024 shows that the market share of the Chinese brand InMeDa has further increased to 58%, continuing to rank first in the market; Sonoscape rose to second place with an 18% market share.

On July 23, Shenzhen Chipscreen Biosciences Co., Ltd. (688321.SH) received approval from the National Medical Products Administration (NMPA) for a Phase III clinical trial application of its first-in-class anti-tumor drug Chidamide in combination with Sintilimab and Bevacizumab for the treatment of Colorectal Cancer (CRC).

On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for Chiral Bioscience's PPAR full agonist, Ciglitazar Sodium Tablets, has been approved. According to an earlier announcement by Chiral Bioscience, the newly approved indication for Ciglitazar Sodium is: in combination with metformin for the treatment of patients with type 2 diabetes whose blood glucose levels are not well controlled by metformin monotherapy.

On July 21, Jiangsu Quanxin Biopharmaceutical Co., Ltd. (2509.HK), which focuses on biologic therapies for autoimmune and allergic diseases, and Huadong Medicine Co., Ltd. (000963.SZ), a large comprehensive pharmaceutical listed company, jointly announced that Quanxin Biopharmaceutical and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine, have once again joined hands. The two parties signed a cooperation development and marketing service agreement for Quanxin Biopharmaceutical's self-developed QX005N (recombinant humanized IL-4Rα monoclonal antibody) injection.

Recently, the "China AIDS Diagnosis and Treatment Guidelines (2024 Edition)" (hereinafter referred to as the "Guidelines") was officially released. Frontier Biopharmaceuticals (Nanjing) Co., Ltd. (688221.SH), exclusive product Aikening.^®As the only long-acting HIV-1 fusion inhibitor (FI) produced in China, after being included in the 2018 and 2021 editions of the Guidelines, it has once again received authoritative endorsement. It has been listed again as a recommended medication regimen in the 2024 edition of the Guidelines for use in cases of co-infection with HCV, co-infection with Mycobacterium tuberculosis, treatment failure, methadone maintenance for intravenous drug dependence, and post-exposure prophylaxis, fully demonstrating the value of Aikening.^®Excellent clinical value.

The 25th International AIDS Conference (AIDS 2024) was grandly convened in Munich, Germany. Frontier Biopharma's product, Aikening^®Important research findings on patients with incomplete immune reconstitution, after being presented at the European AIDS Conference (EACS 2023) in October 2023, have once again been included and published at the 25th International AIDS Conference.

On July 8, Ascentage Pharma (6855.HK) announced that its original Class 1 new drug, Olverembatinib (brand name: Nulrex®), has officially been approved for marketing by the Drug Administration of Macao Special Administrative Region (ISAF).

Recently, PrimaTek's 13 products have obtained the NDR CE certificate issued by the EU Notified Body TÜV SÜD. This marks the first time PrimaTek has received the IVDR CE certificate, providing strong support for the global sales of the company’s in vitro diagnostic products.

Recently, HRS-9813 Tablets, developed by Guangdong Hengrui Medicine Co., Ltd., a subsidiary of Hengrui Medicine, have officially received clinical trial approval. As an experienced CRO enterprise, TQ Biotechnology provided comprehensive toxicology testing for the project, leveraging its well-established and mature service system to facilitate the efficient completion of the project, leading to its successful approval.

On July 10-11, Hubei Tianqin Biotechnology Research Institute Co., Ltd. and Hubei Tianqin Xincheng Pharmaceutical Technology Co., Ltd., both wholly-owned subsidiaries of Tianqin Biotech, respectively underwent a double-random inspection and annual review by a team of eight experts from the Provincial Department of Science and Technology. After three hours of on-site inspection and record review by the expert panel, both companies passed with flying colors in one go.

Recently, RelaBio's new product, the Heparin-Binding Protein (HBP) Detection Kit, has passed the review for the Medical Device Registration Certificate of the People's Republic of China (In Vitro Diagnostic Reagent). The approval of this new product not only recognizes RelaBio's R&D capabilities but also marks the rapid development of the company’s products towards diversification.

Harbour BioMed (02142.HK), a global biopharmaceutical company focused on the discovery, development, and commercialization of innovative antibody therapies in the fields of oncology and immunology, has announced a positive profit forecast for the first half of the year ended June 30, 2024 (reporting period).

According to the CDE official website, HBM9027 Injection, a Class 1 new drug developed by Harbour BioMed, has received clinical trial implied permission for the indication of advanced solid tumors. Public information shows that HBM9027 is a PD-L1xCD40 bispecific antibody.

Recently, the National Center for Clinical Laboratories of the National Health Commission announced the results of the 2024 China-wide External Quality Assessment for High-throughput Sequencing Detection of Tumor Circulating DNA Gene Mutations. 3D Medicines achieved a perfect score in this external quality assessment, once again demonstrating that the accuracy, reliability, and standardization of 3D Medicines' detection of solid tumor circulating DNA have been recognized by authoritative institutions in China.

Recently, the European Molecular Genetics Quality Network (EMQN) and the College of American Pathologists (CAP) successively announced the results of the 2023 EMQN DNA Sequencing (Solid Tumors + Control Samples) and the 2024 CAP RNA-A External Quality Assessment programs. Maijing achieved perfect scores in all assessments. Notably, Maijing has consecutively achieved full marks in the CAP RNA-A program for six times (from 2019 to 2024)!

Recently, LY-M003 Injection, independently developed by Lingyi (Hangzhou) Biotechnology Co., Ltd., has been granted the Pediatric Rare Disease Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Wilson's disease, also known as hepatolenticular degeneration.

On the morning of July 14, the interim investigator meeting for the Phase IIb clinical study of ZSP1601 tablets in treating non-alcoholic steatohepatitis, organized by Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd., was successfully held in Guangzhou.