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Ascletis Pharma plans to raise HK$835 million through a share placement to advance Phase III clinical trials of its weight loss drug ASC30

Ascletis Pharma-B announced a proposed placement of 69.256 million shares, representing approximately 6.98% of the enlarged share capital. The placement price is HK$12.18 per share, representing a discount of approximately 4.0% to the closing price of HK$12.69 on February 2. The net proceeds are expected to be approximately HK$835 million. The company’s purpose in this round of financing is very clear: 90% of the funds (approximately HK$750 million) will be directly used for the development of its core pipeline, ASC30. ASC30 is a small-molecule oral GLP-1 receptor agonist for the treatment of obesity. This funding will be specifically used for the preparation, groundwork, and formal initiation of its global Phase III clinical trials. https://finance.eastmoney.com/a/202602033639376910.html
- Source: drugdu
- 56
- February 4, 2026
Midea Biopharma’s SELNP platform advances oral administration of paclitaxel with dual clinical trial approvals in China and the US.

Paclitaxel, a cornerstone drug in the field of cancer chemotherapy, has become a basic treatment for various solid tumors, including breast cancer, ovarian cancer, and lung cancer, since its clinical application in the 1990s, and still maintains a global market size of nearly ten billion US dollars. However, in contrast to its repeatedly verified efficacy, the administration method has stagnated for a long time—for more than 30 years, the clinical application of paclitaxel has still relied heavily on intravenous infusion, and the therapeutic effect has reached a plateau, making it difficult to improve further. This drug delivery route means that patients need to make periodic trips to the hospital for treatment, while also enduring adverse events related to excipients such as allergic reactions and neurotoxicity, and consuming a significant amount of medical resources. Despite the emergence of numerous new therapies, the bottlenecks in the delivery method and user experience of ...
- Source: drugdu
- 53
- February 4, 2026
Huadong Medicine achieves another breakthrough in the autoimmune market! Roflumilast cream 0.05% has been submitted for market approval.

On February 3, 2026, Huadong Medicine (stock code: 000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd., had its marketing authorization application for the innovative topical skin preparation roflumilast cream (ZORYVE®) 0.05% accepted by the National Medical Products Administration (NMPA). The product is indicated for the topical treatment of mild to moderate atopic dermatitis in patients aged 2 to 5 years. This marks an important milestone in the research and development of this series of products and will further consolidate and enhance the company’s core competitiveness in the field of autoimmune skin treatment. The product has significant advantages, building dual barriers in both clinical and commercial applications. The announcement indicates that the active ingredient in ZORYVE® is Roflumilast, a highly active and selective nonsteroidal phosphodiesterase-4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and reduces the production of anti-inflammatory mediators. Inhibiting ...
- Source: drugdu
- 46
- February 4, 2026
A win-win partnership! Jiangsu Weikaier’s Class 1 innovative drug VC005 gel has reached a cooperation agreement with Sunshine Novo.

Recently, Jiangsu Weikaier Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Jiangsu Weikaier”) and Beijing Sunshine Novo Pharmaceutical Research Co., Ltd. (hereinafter referred to as “Sunshine Novo”) officially signed a cooperative research and development agreement. The two parties will give full play to their respective advantages in the field of new drug research and development, and work together to promote the research and development of Jiangsu Weikaier’s Class 1 innovative drug VC005 topical gel (specification: 1%) (hereinafter referred to as “cooperative product”), and accelerate the product’s market launch process so as to benefit the majority of dermatitis patients as soon as possible. The product boasts strong capabilities and demonstrates outstanding clinical potential. VC005 topical gel (1% concentration), a novel, locally applied, second-generation highly selective JAK1 inhibitor, is clinically used to treat mild to moderate atopic dermatitis (AD). In completed Phase II clinical trials, it demonstrated excellent safety and remarkable efficacy—not ...
- Source: drugdu
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- February 4, 2026
【EXPERT Q&A】What are the requirements of the EU medical device regulations for General Safety and Performance Requirements (GSPR)?

Drugdu.com expert’s response: General Safety and Performance Requirements (GSPR) under EU Medical Device Regulations: A Core Framework for Ensuring Safety and Effectiveness The GSPR, outlined in Annex I of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), serves as the cornerstone for ensuring the safety and effectiveness of medical devices in the EU. Its requirements span multiple critical domains, as detailed below: I. Core Components of GSPR GSPR is structured into three chapters in Annex I of the MDR/IVDR: Chapter 1: General Requirements Based on Risk Management Medical devices must function as intended without endangering the health or safety of patients, users, or third parties. Risks must be reduced to an acceptable level without compromising the risk-benefit ratio. For example, design modifications that lower risks but impair device performance or benefits require re-evaluation. Manufacturers must establish, implement, and maintain a risk management system throughout the device lifecycle (e.g., ...
- Source: drugdu
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- February 4, 2026
Its groundbreaking innovative drug, Ruxolitinib Phosphate Cream, has been approved for marketing in China. It is the first and only targeted drug approved in China for the treatment of vitiligo.

Ruxolitinib phosphate cream is the first and only targeted drug approved in China for the treatment of vitiligo, bringing new hope to millions of vitiligo patients in China and marking a significant milestone. Both overseas Phase III clinical trials of the product for the treatment of vitiligo met their primary endpoints: after 24 weeks of treatment, the proportion of patients with F-VASI 75 was 29.9%, significantly higher than the 7.5% and 12.9% in the placebo group. Continued use up to 52 weeks showed sustained repigmentation. Furthermore, real-world studies in China also showed positive efficacy, consistent with the results of pivotal clinical studies abroad; all secondary efficacy endpoints in both domestic and international clinical studies showed a benefit trend consistent with the primary efficacy endpoint, and the treatment effect continued to improve with the extension of treatment duration. This approval will further enrich Demag Pharmaceuticals’ product portfolio and is expected to ...
- Source: drugdu
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- February 3, 2026
Lunan Pharmaceutical’s Bilastin Receives Marketing Approval in Japan

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a GMP compliance inspection notification from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its product Bilastin (MF registration number: 307MF10026), marking its official acquisition of commercial sales qualification in the Japanese market . This active pharmaceutical ingredient received approval for its marketing application in China in April 2025. It is the sixth MF approved in Japan, following miglitol, montelukast sodium, tegafur, isosorbide, and mosapride citrate. This successful acquisition of market access in Japan provides crucial qualifications for its expansion into the international market. Bilastin is used for the symptomatic treatment of urticaria in adults and adolescents (12 years and older). It is a second-generation non-sedating long-acting histamine antagonist with selective peripheral H1 receptor antagonist affinity, no affinity for muscarinic receptors, no sedative effect, no cardiotoxicity, and does not interact with cytochrome P450 enzyme ...
- Source: drugdu
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- February 3, 2026
Sinovac Biotech expects its net profit to increase by 328.83% to 455.89% in 2025

Sinovac recently released its 2025 annual performance forecast. The company expects its net profit attributable to shareholders to be between RMB 135 million and RMB 175 million in 2025, representing a year-on-year increase of 328.83% to 455.89%. The company stated that this performance growth is the result of its long-term implementation of the “innovation + internationalization” dual strategy. the innovative drug pipeline lay the foundation for revenue growth. According to reports, in 2025, Sinovac Biotech focused on the fields of oncology, autoimmune diseases, and metabolism, actively developing both first-in-class (FIC) and best-in-class (BIC) drugs. Among them, GB18 injection, a drug for treating cancer cachexia, has received clinical trial approvals from the US FDA and the Chinese NMPA, and is currently actively advancing its Phase I clinical trial in China, leading the domestic pipeline for the same target and indication. GB24, focusing on inflammatory bowel disease, is expected to address the ...
- Source: drugdu
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- February 3, 2026
Major approval! The world’s first cAMP-biased GLP-1 inhibitor, Synvita’s “Enoglutide,” has been approved for marketing

Enoglutide Injection (formerly known as Enoglutide, code name XW003), independently developed by Hangzhou Xianweida Biotechnology , for the purpose of glycemic control in adults with type 2 diabetes. This is Syntec’s first commercialized product and the world’s first approved cAMP-biased GLP-1 receptor agonist. of enoglutide is its world-first cAMP-biased mechanism of action, which is the key difference between it and existing GLP-1 products. Traditional GLP-1 products are “unbiased,” and when they activate the beneficial cAMP signaling pathway, they recruit β-arrestin, leading to receptor desensitization and affecting long-term efficacy. In contrast, enoglutide, through precise molecular design, can selectively activate the cAMP pathway and minimize β-arrestin recruitment, maintaining continuous therapeutic signals. Its development is based on the biased activating theory/concept derived from the Nobel Prize-winning GPCR research , which has significant scientific implications. This product is a long-acting weekly formulation, administered via subcutaneous injection, and its activity and production capacity are enhanced ...
- Source: drugdu
- 51
- February 3, 2026
Evidence-based breakthrough! Traditional Chinese medicine for anti-fibrosis selected again for the National Science and Technology Major Project

In the field of liver disease, the long-term damage caused by the vast majority of chronic liver diseases leads to the occurrence and development of liver fibrosis. The degree and rate of progression of liver fibrosis directly affect the risk of cirrhosis and liver cancer. Therefore, effective intervention and reversal of the liver fibrosis process are of vital clinical significance. Unlike other disease treatment areas, traditional Chinese medicine (TCM) has shown unique potential in this field. Recently, Ganxianle® , a modern TCM product under Baiyang Pharmaceuticals , which strengthens the body’s resistance and removes blood stasis, participated in the National Science and Technology Major Project led by Beijing Ditan Hospital affiliated to Capital Medical University—”Research on the Comprehensive Evaluation System and Optimization Scheme of the Whole Chain of Integrated Traditional Chinese and Western Medicine Treatment to Reverse Hepatitis B Cirrhosis”. The selection criteria for the National Science and Technology Major ...
- Source: drugdu
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- February 3, 2026

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