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Harsco Pharmaceutical’s innovative drug HSK50042 tablets receive clinical approval for a new indication

on the evening of March 5th that Harsco Pharmaceutical…(002653) issued an announcement stating that its subsidiary, Shanghai Haishengnuo Pharmaceutical Technology Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, with the indication being respiratory diseases. Harsco Pharmaceuticals stated that HSK50042 tablets are an orally administered, potent, and highly selective small molecule inhibitor independently developed by the company. This latest approval for a new indication in the field of respiratory diseases marks another significant milestone in its clinical trials. Preclinical studies have shown that HSK50042 can effectively improve the pathological symptoms of lung diseases in model mice at relatively low doses, demonstrating good efficacy, good tolerability, and a large safety window. It is a drug with great development potential and is expected to provide patients with respiratory diseases with a highly effective and safe new treatment option. https://finance.eastmoney.com/a/202603053663302749.html
- Source: drugdu
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- March 6, 2026
Clinical trial application for HLX97 approved by the National Medical Products Administration

On March 5th, Henlius Biotech (02696.HK) issued a voluntary announcement stating that its Investigational New Drug (IND) application for HLX97 (a small molecule inhibitor of KAT6A/B), developed independently, in patients with advanced/metastatic solid tumors, has been approved by the National Medical Products Administration (NMPA). HLX97 is a small molecule inhibitor targeting the lysine acetyltransferase KAT6A/B. Non-clinical studies have shown that it has good anti-tumor efficacy and safety characteristics; currently, there are no similar KAT6A/B small molecule inhibitors approved for marketing globally. This progress marks an important milestone in the company’s innovative oncology treatment pipeline, and clinical research will proceed as planned. Given the long development cycle, high investment, and high risk of new drug development, the company cautions that it cannot guarantee the ultimate successful development and commercialization of HLX97, and investors are advised to be aware of the investment risks. 网址：https://finance.eastmoney.com/a/202603053663239623.html
- Source: drugdu
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- March 6, 2026
【EXPERT Q&A】Why is it so difficult to obtain the qualifications for Class II and Class III medical devices?

Drugdu.com expert’s response: The difficulty in obtaining qualifications for Class II and III medical devices lies in high product risks, strict supervision, complex procedures, high professional thresholds, large investment, long cycles, and enterprises often being rejected repeatedly due to insufficient compliance capabilities, non-standard materials, or non-compliance with requirements for premises, personnel, and systems. I. Root Cause: Supervision Intensity Determined by Risk Level Class II (medium risk) e.g., blood glucose meters, electrocardiographs, surgical masks. They contact the human body or carry certain injury risks, requiring registration/filing + strict system management. Class III (high risk) e.g., cardiac stents, artificial joints, ventilators, in vitro diagnostic reagents. Directly related to life safety, requiring strict approval, mandatory clinical trials, and full-chain supervision. II. Process & Approval Difficulty 1. Registration (Most Difficult) Class II: Approved by provincial medical products administrations. Requires product testing + clinical evaluation (some exempt) + system ...
- Source: drugdu
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- March 6, 2026
Eli Lilly wins another victory! Regcizosumab submits its marketing application in China

On March 3, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China showed that Eli Lilly and Company’s application for marketing authorization of its Class 3.1 new drug, Lerechizumab injection, has been accepted.Lebrikizumab is an interleukin-13 (IL-13) inhibitor that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate. The binding site of lebrikizumab to the IL-13 cytokine overlaps with the binding site of the IL-4Rα subunit in the IL-13Rα1/IL-4Rα heterodimer, thereby preventing the formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is a major cytokine in atopic dermatitis, driving type 2 inflammation in the skin, leading to skin barrier dysfunction, itching, skin thickening, and infection.The development of lericizumab has been a long and winding road. Originally developed by Roche, the drug began its first clinical trial in 2008, but its initial indication of asthma ...
- Source: drugdu
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- March 5, 2026
Henlius’s potential best-in-class small molecule drug receives its first clinical trial approval

On March 4, the CDE (Center for Drug Evaluation) website showed that Henlius’ HLX97 clinical trial application was approved for the treatment of advanced/metastatic solid tumors. This is the third domestically produced KAT6A/B inhibitor to receive clinical trial approval. Source: CDE Official Website HLX97 is a novel, potentially best-in-class oral histone acetyltransferase (KAT6A/B) inhibitor . KAT6A/B is a highly promising target for the treatment of solid tumors such as breast cancer, and its abnormalities are closely associated with the development and progression of various hematologic malignancies and solid tumors. HLX97 regulates the proliferation, differentiation, and apoptosis of tumor cells by precisely inhibiting the activity of KAT6A/B. It has pharmacokinetic characteristics of rapid onset and rapid clearance and high selectivity. It aims to maximize the anti-tumor activity of the drug while reducing the blood toxicity of the product, and is expected to bring new treatment options to patients with cancers such ...
- Source: drugdu
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- March 5, 2026
New anti-aging drug approved for clinical trials

On March 2nd, RC017 , an innovative drug developed by Nanjing Ruichu Pharmaceuticals targeting the mechanisms of aging to treat eye diseases , officially received FDA approval for clinical trials in the United States. Notably, this is the first time in FDA history that a Chinese anti-aging innovative drug clinical trial application has been approved. RC017 is one of the core pipelines of Ruichu Pharmaceuticals, focusing on “targeting aging mechanisms.” The company employs a unique “three-platform R&D strategy,” focusing on key biological pathways such as chronic inflammation, clearance of senescent cells, and cell reprogramming. Research shows that with age, the common molecular basis of many degenerative diseases converges on chronic inflammatory pathways, and the RC series of drugs is based on the identification and intervention of emerging first-in-class inflammation-related targets. Founded in June 2021 and headquartered in Nanjing, Ruichu Pharmaceuticals is a leading Chinese company focused on the biology of ...
- Source: drugdu
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- March 5, 2026
First in the world and first in China, Yahong Pharmaceutical’s non-invasive treatment for cervical precancerous lesions, Cervita, has been approved

(China, March 3, 2026) Asarum Pharmaceuticals (stock code: 688176.SH), a global innovative pharmaceutical company focusing on urogenital tumors and women’s health, announced that its core product APL-1702 (trade name: Cevira®, generic name: Hexyl valerate hydrochloride ointment for cervical photodynamic therapy) has received a Drug Registration Certificate issued by the National Medical Products Administration of China, officially approving its market launch. This product is the world’s first non-surgical, non-invasive treatment for patients with cervical intraepithelial neoplasia grade 2 (CIN2), filling a clinical gap in this treatment area and redefining a potentially huge blue ocean market for non-invasive treatments. Currently, cervical cancer remains a major threat to women’s health worldwide. According to a 2023 market survey, the number of patients with high-grade squamous intraepithelial lesions (CIN2) diagnosed by histopathology in my country exceeds 700,000, of which approximately 60% are CIN2. It is projected that the incidence, screening rate, and diagnosis rate will ...
- Source: drugdu
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- March 5, 2026
Its investee company’s PA3-17 injection has received clinical approval for a new indication, expanding the applicable population to children and adolescents

Anke Biotechnology(300009) announced on the evening of March 4 that its investee companies, Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd. and Boshengji Anke Cell Technology Co., Ltd. (collectively referred to as “Boshengji Anke”), received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration. The application for a new indication for its independently developed PA3-17 injection was approved, and it was agreed to conduct clinical trials for the treatment of relapsed/refractory T-lymphoblastic leukemia/lymphoma in children and adolescents. PA3-17 injection is the world’s first CD7-targeting autologous CAR-T cell therapy product independently developed by Boshengji Anke and approved for clinical trials. It has been included in the “Breakthrough Therapy” list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The product is currently undergoing a pivotal Phase II clinical trial for adult patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma. The approval of this clinical trial for PA3-17 injection ...
- Source: drugdu
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- March 5, 2026
Subsidiary’s Imicizumab Injection Receives Clinical Trial Approval

Xin Nuowei(300765) announced on the evening of March 4 that its controlling subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., recently received a “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration for emecizumab injection (SYS6053), agreeing to conduct clinical trials as a biosimilar of emecizumab. SYS6053 is a modified humanized IgG4 monoclonal antibody with a bispecific antibody structure that bridges coagulation factors IXa and X. It is a biosimilar of the original drug, Shuyoule®, and is indicated for patients with hemophilia A. This product is classified as a therapeutic biological product .For Category 3.3 applications, the research and development follows the relevant guidelines for biosimilars. Pharmaceutical and non-clinical research results show that the biosimilar is highly similar to the original reference drug in terms of quality, safety and efficacy, supporting the conduct of subsequent clinical studies. Xin Nuowei notes that after obtaining clinical trial approval, drugs still need ...
- Source: drugdu
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- March 5, 2026
TOKYO INTERPHEX Week

Organiser：Reed Exhibitions Time：May 20 – 22, 2026 Address：3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall：Tokyo Big Sight International Exhibition Center Product range: Biomaterials: Amplification equipment, DNA extraction equipment, proteome extraction and purification, DNA analysis equipment, proteome analysis equipment, nuclear magnetic resonance (NMR), automated workstations, automatic dispensers, cell analysis equipment, incubators, cold storage, nutrient media, stirrers, pipettes, assay kits, regenerative medicine, drug development, biomaterials, biological contracts, pharmaceutical intermediates, cosmetic ingredients, fine chemicals, additives, excipients, plant extracts. Instruments & Equipment: Analytical instruments, laboratory equipment and accessories, chemical reagents. Bioengineering: Bioprocessing, biochemistry, biotechnology and products, analytical methods, nanobiotechnology and products, optics and technology. Bioinformatics & Services: Bioinformatics, biotechnology services. Medical & Pharmaceutical Applications: Medicine and pharmaceuticals, biologics, biosimilars and biobetters. Environmental Applications: Environmental biotechnology, agricultural applications, agricultural products / plant biotechnology, animal husbandry. Pharmaceutical Excipients: Pharmaceutical packaging materials, pharmaceutical excipients, excipient-related equipment; Excipients: antimicrobial preservatives, antioxidants, capsules / encapsulation, coating agents, colors and dispersions, drug delivery systems, emulsifiers / ...
- Source: drugdu
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- March 5, 2026

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