Recently, Zaijing Pharmaceuticals announced that its independently developed Class 1 new drug, gecacitinib hydrochloride tablets (formerly known as jactinib hydrochloride tablets), has met its primary efficacy endpoint in a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial for the treatment of moderate to severe atopic dermatitis in adult patients , demonstrating statistical significance (p<0.0001). This signifies another major breakthrough for Zaijing Pharmaceuticals in the field of autoimmune diseases. Gecacitinib is a novel dual inhibitor of JAK and ACVR1 independently developed by Zaijing Pharmaceuticals , and is classified as a Class 1 new drug. This drug received NMPA approval in May 2025 for the treatment of intermediate- and high-risk myelofibrosis, making it the first domestically produced innovative JAK inhibitor approved for the treatment of myelofibrosis. In addition, the NMPA has accepted the NMPA application for the indication of severe alopecia areata and is currently under review and approval; the three clinical ...
Organiser:Shanxi Medical Device Industry Association Time:May 15 – 17, 2026 Address:No. 6, Changfeng West Street, Taiyuan Exhibition hall:Taiyuan Jinyang Lake International Convention and Exhibition Center Product range: Medical Imaging: 5G remote solutions, precision imaging, intelligent imaging, smart hospital systems, etc. Medical Electronics: critical care medicine equipment, blood transfusion, dialysis, and extracorporeal circulation devices, maternal and child health and tumor treatment equipment, electronic therapeutic devices, etc. In Vitro Diagnostics: molecular diagnostics, point-of-care testing (POCT), immunoassays, cancer screening, biochemical testing, laboratory overall solutions, biological sample storage and transportation, home rapid testing, etc. Medical Optics: 5G technology-based surgical endoscopy solutions, brand-new high-definition endoscopes, capsule endoscopes, laser therapy devices, etc. Medical Consumables: high-value consumables, surgical consumables, nursing consumables, protective consumables, etc. Disinfection and Infection Control: disinfection supply centers, endoscope cleaning centers, infant bathing centers, air disinfection equipment, third-party disinfection outsourcing Rehabilitation Medicine: rehabilitation training equipment, functional assessment devices, training room auxiliary devices, diagnostic ...
On April 14, 2026, Henlius Biotech (2696.HK) announced that its Investigational New Drug (IND) application for HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), a cetuximab biosimilar developed by the company, was approved by the National Medical Products Administration (NMPA) of China for the treatment of metastatic colorectal cancer. Epidermal growth factor receptor (EGFR) belongs to the ErbB family of cell surface erythroleukemia virus oncogene homologs with tyrosine kinase activity. It is a transmembrane glycoprotein widely expressed in normal epithelial cells and tumor tissues such as colorectal cancer and head and neck cancer. EGFR-mediated signaling pathways regulate tumor growth through multiple pathways and play a key regulatory role in the proliferation, differentiation, survival, and metastasis of tumor cells. Therefore, it is considered an important therapeutic target for related tumors. Cetuximab specifically binds to EGFR on the cell surface. On one hand, it competitively inhibits the binding of ligands such as ...
On April 14, 2026, Hangzhou Sino-American Huadong Pharmaceutical Jiangdong Co., Ltd. (hereinafter referred to as “Jiangdong Company”), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”), received the “Acceptance Notice” issued by the National Medical Products Administration (NMPA), in which the marketing authorization application for Smegglutide injection (research code: HDM1702) submitted by Jiangdong Company was accepted. The indication for this application is: This product is suitable for long-term weight management in adult patients based on diet control and increased physical activity, with an initial body mass index (BMI) meeting the following criteria: ≥30kg/m2 ( obese), or ≥27kg/m2 to <30kg/m2 ( overweight) and having at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Regarding Smegglutide injection Smegglutide injection is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with 94% sequence homology to human GLP-1. Clinically, it is mainly used for ...
Recently , Hisun Pharmaceutical surprised the market with two pieces of good news: its net profit for the first quarter of 2026 is expected to increase by 923% to 1095% year-on-year, which is close to twice the net profit of RMB 260 million for the whole of 2025; at the same time, Hisun Pharmaceutical officially announced a licensing cooperation with pharmaceutical giant AbbVie for Nav1.8 inhibitors with a total value of up to US$745 million . >>The Logic Behind the Explosive Growth in Performance Hisun Pharmaceutical expects to achieve a net profit attributable to shareholders of RMB 477 million to RMB 557 million in the first quarter, nearly double its net profit for the entire year of 2025 (RMB 260 million). The core drivers of this surge in performance are twofold: first, the continued strong sales of innovative products such as propofol and cogglitazone, resulting in significant market expansion success; ...
Alloy Therapeutics recently announced a collaboration and licensing agreement with Biogen, authorizing Biogen to use Alloy’s novel and proprietary AntiClastic™ antisense oligonucleotide (ASO) platform to advance antisense therapies targeting multiple undisclosed targets. Alloy will receive an upfront payment and will be eligible for additional milestone payments and tiered royalties based on any products generated from the collaboration. It is worth noting that Biogen has been deeply involved in the ASO field for many years and has the blockbuster ASO drug Spinraza in hand. This time, choosing to use an external platform to promote the development of the next-generation ASO pipeline is both an endorsement of the Alloy technology platform and an expectation for the next generation of ASO drugs. 01 Biogen’s anxiety In 2025, Boquan’s annual revenue was $9.9 billion, failing to break the $10 billion mark for the third consecutive year, and far from its peak of $14.38 billion ...
Drugdu.com expert’s response: Process and Key Points for the Registration of Class II Medical Device Products I. Eligibility Requirements 1. Corporate Qualifications The applicant must be a legally registered enterprise within China, with a business license covering medical device production or operation. The enterprise must have passed GMP certification and possess a quality management system, production facilities, and testing equipment commensurate with its production scale. For imported products, the applicant must provide an Import Medical Device Registration Certificate and information about the authorized agent. 2. Product Requirements The product must comply with national mandatory standards and not be listed on prohibited production or sales lists. Clinical trial conclusions (issued by at least three medical institutions, stating “satisfactory safety and efficacy”) are required. Information such as indications and scope of use must align with the product instructions and regulatory requirements. 3. Personnel and Facilities The enterprise must employ full-time quality management personnel with ...
Recently, Wanbangde Pharmaceutical released its performance forecast, showing that it expects to achieve a net profit attributable to the parent company of 165 million yuan in the first quarter of 2026, an increase of 985.40% compared with 15.2018 million yuan in the same period last year ; even more impressive is the net profit excluding non-recurring items, which reached 164 million yuan, while the same period last year was a loss of 7.9053 million yuan, a year-on-year increase of 2174.55% . This performance stands in stark contrast to the company’s 2025 results. According to the company’s previously disclosed preliminary 2025 financial report, Wanbangde’s revenue for the entire year was 1.145 billion yuan, a year-on-year decrease of 20.69%; net profit attributable to the parent company was a loss of 199 million yuan, a significant decrease of 458.54% compared to 55.441 million yuan in the same period of the previous year. The ...
Roxadustat capsules from FibroGen (China) . In terms of specific sales figures, Ametinib Mesylate tablets topped the list with sales of 5.53 billion yuan , far ahead of the competition, followed by Vometinib Mesylate tablets with 3.757 billion yuan . The threshold for the top ten has risen to 1.7 billion yuan, with total sales exceeding 26.5 billion yuan. Domestic companies such as Hengrui Medicine, BeiGene, Hansoh Pharmaceutical, Allis, Simcere Pharmaceutical, and Akeso Biopharma are the main players on the list, demonstrating the vigorous vitality of pharmaceutical innovation in China. Note: The products listed in this article are Class 1 innovative drugs approved for marketing in 2016 for chemical drugs and 2020 for traditional Chinese medicine and biological products. Sales data cover the three major terminal markets of domestic hospitals, retail and e-commerce. 01 Domestic innovative drugs account for 9 seats The 2025 list of the top 10 innovative drugs ...
Low-density lipoprotein cholesterol (LDL-C) is also known as “bad cholesterol.” Elevated LDL-C levels can lead to hypercholesterolemia, a condition that often further contributes to the formation of arterial plaques. Data from the New England Journal of Medicine (NEJM) shows that excessively high LDL-C levels increase the global risk of death from chronic diseases by 6.4 times, making it arguably the “most insidious threat to life.” On April 8, 2026, Merck officially announced that it had presented detailed Phase III data for its oral PCSK9 inhibitor Enlicitide (MK-0616) CORALreef AddOn at the 2026 American College of Cardiology (ACC) Annual Meeting. The results were simultaneously published in the *Journal of the American College of Cardiology* ( JACC ) . As the world’s first oral PCSK9 inhibitor to enter Phase III clinical trials, this drug demonstrated overwhelming superiority in head-to-head trials, potentially ending the “injection era” for this target . picture According to ...
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