Beijing Business News (Reporter Ding Ning) – On the evening of November 25th, Honz Pharmaceutical Co., Ltd. (300086) issued a statement, announcing that recently, the company’s “Cough Suppressant Juhong Granules” has obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration. The announcement shows that Cough Suppressant Juhong Granules is a product that the company has already produced and is currently on sale. It was originally a national second-level protected traditional Chinese medicine variety (with a protection period until September 13, 2016), and its current indications are “clearing the lungs, suppressing cough, and resolving phlegm. It is used for cough with excessive phlegm, chest fullness, shortness of breath, dry throat and itchy throat caused by phlegm heat blocking the lungs.” Based on the latest clinical research and expert consensus, the company submitted a clinical trial application to add a new indication of “acute exacerbation of chronic ...
Novo Nordisk has released the clinical trial data for the new diabetes drug amycretin, showing that the drug not only lowers blood sugar but also has a significant weight loss effect. The trial results indicate that the amycretin injection, administered once a week, can help patients lose up to 14.5% of their weight within 36 weeks; the oral formulation can achieve a weight loss of up to 10.1% per day. This positive news has pushed the stock price of Novo Nordisk’s US shares to rise, recovering most of the losses it suffered previously due to the failure of its Ozempic oral version to slow the progression of Alzheimer’s disease in two clinical trials. Amycretin is a key component of Novo Nordisk’s new drug portfolio, integrating two weight loss mechanisms into a single molecule, aiming to improve the company’s competitive position in the field of obesity treatment. https://finance.eastmoney.com/a/202511263574807587.html
Drugdu.com expert’s response: The handling of medical device business licenses presents certain difficulties, but with systematic preparation and standardized operations, it can be completed successfully. The main challenges lie in complex policies and regulations, stringent technical requirements, cumbersome material preparation, a lengthy approval process, and a scarcity of professional talent. However, enterprises can reduce these difficulties through advance planning, standardized operations, and seeking professional support. The following is a detailed analysis: Difficulties in Handling Complex Policies and Regulations: The handling of medical device business licenses involves numerous regulations such as the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration.” These regulations are complex and frequently updated, requiring enterprises to continuously learn and adapt. Otherwise, they may easily fail in their applications due to non-compliant operations. Stringent Technical Requirements: During the handling process, sufficient technical materials and proofs must be ...
November 25th, Mabwell Biotechnology announced on its official WeChat account that it has developed an innovative CDH17-targeting ADC drug.(Development code: 7MW4911) The first patient was recently dosed in a Phase I/II clinical trial for advanced solid tumors. Preclinical studies showed that 7MW4911 exhibited potent antitumor activity in CDX/PDX models of various gastrointestinal tumors; in multidrug-resistant models, its antitumor effect was significantly superior to MMAE/DXd ADCs, and it could reverse tumor progression after treatment with such ADCs, highlighting its advantages in the treatment of drug-resistant tumors. https://finance.eastmoney.com/a/202511253573547662.html
Jiuzhou PharmaceuticalThe announcement states that Zhejiang Jiuzhou Pharmaceutical Co., Ltd. received chemical raw materials from the National Medical Products Administration.The company recently received the Approval Notice for Marketing Authorization of its chemical active pharmaceutical ingredient, edoxaban tosylate. This oral anticoagulant is primarily used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as to treat or prevent deep vein thrombosis and pulmonary embolism. This approval indicates that the active pharmaceutical ingredient meets the relevant requirements for national drug registration and will further enrich the company’s product portfolio and enhance its market competitiveness. The above matters will not have a significant impact on the company’s performance in the short term. https://finance.eastmoney.com/a/202511243572990379.html
Northeast Pharmaceutical recently stated in an interview with China Securities Journal that in recent years, the company has focused on innovation-driven strategies and deepening its core business, achieving significant results in R&D breakthroughs and business quality improvement. This has established a synergistic development pattern characterized by “breaking new ground in R&D innovation, stabilizing profitability in core business, and enhancing efficiency in asset operations.” Particularly against the backdrop of accelerating innovation and transformation in the pharmaceutical industry, the company has adopted a differentiated strategy of “consolidating the fundamental business through traditional operations while creating new growth drivers through innovative drug development.” This approach has not only safeguarded its profit baseline but also unlocked new growth potential. Recently, the company’s subsidiary, Dingcheng Peiyuan, received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) for its self-developed DCTY0801 Injection. Looking ahead, as the innovative drug pipeline advances and ...
November 24 (NBD AI Express) — According to an update on China National Biotec Group (CNBG)’s official WeChat account, Wuhan Biological Products Institute, its subsidiary, has recently achieved significant progress in the field of pediatric vaccine development. The Sabin strain inactivated poliovirus vaccine (Vero cell) has received market approval from the National Medical Products Administration (NMPA) (Approval No.: S20250060). Simultaneously, the Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, and Haemophilus Influenzae Type b (Conjugate) Combined Vaccine has obtained clinical trial approval (Acceptance No.: CXSL2500756). Reference:https://finance.eastmoney.com/a/202511243572908132.html
In the vast and complex field of chronic kidney disease, IgA nephropathy (IgAN) has long been considered a “silent corner.” However, with a deeper understanding of its pathogenesis and breakthroughs in treatment, this once-neglected disease area is now showing renewed vitality. 01 Changes in the Times The unique aspect of IgA nephropathy lies in its complex pathogenesis. Traditionally, it was considered an autoimmune disease, but recent studies have found that its pathogenesis involves multiple steps, including mucosal immune abnormalities, the production of galactose-deficient IgA1, the formation of autoantibodies, and the deposition of immune complexes, ultimately leading to kidney tissue damage through complement activation. The elucidation of this mechanism provides a clear direction for the development of targeted drugs. Current treatment strategies mainly focus on four pathways: (1) Mucosal immune regulation: targeting the initial stage of the pathogen immune response; (2) Inhibition of the endothelin-1 (ET-1) pathway: improving glomerular hemodynamics and ...
Recently, Pfizer’s Padcev and Merck’s Keytruda (including the intravenous infusion version of Keytruda and the subcutaneous injection version of Keytruda Qlex) received early approval from the U.S. FDA for the perioperative treatment of adult patients with muscle invasive bladder cancer (MIBC). This regimen is suitable for MIBC patients who are ineligible for cisplatin-based chemotherapy, specifically consisting of neoadjuvant therapy (3 cycles) followed by adjuvant therapy (14 or 7 cycles). This is the first and only approved complete perioperative treatment regimen for MIBC patients who are ineligible for cisplatin. This approval is based on the results of the pivotal Keynote-905/EV-303 study. This study enrolled adult MIBC patients who were unsuitable for or actively refused cisplatin therapy and aimed to compare the efficacy of PD-1 inhibitor/ADC combination therapy plus surgery versus surgery alone. Merck presented the results of this study at this year’s ESCO annual meeting. After a median follow-up of 25.6 ...
On November 24th, CSPC (01093) released an announcement stating that the group’s independently developed chemical Class 1 new drug, the double-stranded small interfering RNA drug (SYH2061 injection), has been approved by the US Food and Drug Administration (FDA) and can now conduct clinical trials in the United States. Additionally, this product was approved by the China National Medical Products Administration in October 2025 to conduct clinical trials in China. SYH2061 injection is a siRNA drug that achieves liver-targeted delivery through the conjugation of acetylated galactosamine (GalNAc). It aims to target the complement protein C5 (C5) and effectively reduce its level. Preclinical studies have shown that this product outperforms other similar siRNA products in terms of drug activity and drug efficacy persistence, and has high clinical development value. It is suitable for the treatment of IgA nephropathy and other complement-mediated related diseases. https://finance.eastmoney.com/a/202511243573136076.html
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