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Hengrui’s breakthrough hepatitis B therapy arrives

On September 15, the CDE official website announced that Hengrui Medicine’s new generation of liver-targeted hepatitis B virus siRNA drug HRS-5635 injection is planned to be included in the breakthrough therapy variety for the treatment of chronic hepatitis B. Chronic hepatitis B (CHB) is a chronic inflammatory liver disease caused by persistent infection with the hepatitis B virus (HBV). According to the World Health Organization, 254 million people worldwide were living with chronic HBV infection in 2022, with approximately 1.2 million new infections. In China, a major country with a high incidence of CHB, epidemiological data from 2020 estimated that there were approximately 75 million HBV carriers, of whom approximately 30 million were infected but unaware. Of those diagnosed, 17 million required antiviral treatment, but only 3 million received it. In addition, HBV infection significantly increases the risk of developing cirrhosis and liver cancer. The proportion of cirrhosis and liver ...
- Source: drugdu
- 39
- September 17, 2025
Progress in ASC30 Research

On September 17, Ascletis Pharma-B (01672) issued an announcement, announcing that it reported the results of a 28-day multiple-dose escalation study of its ASC30 oral small molecule GLP-1R agonist at the 61st European Association for the Study of Diabetes Annual Meeting held in Vienna, Austria on September 16, 2025. In MAD Cohort 2, once-daily oral administration of ASC30 demonstrated a placebo-adjusted mean weight loss of 6.5% from baseline after 28 days of treatment, compared to a mean weight loss of 4.5% in MAD Cohort 1. The study was well-safe and well-tolerated, with only mild to moderate gastrointestinal adverse events and no serious adverse events. https://finance.eastmoney.com/a/202509173515879467.html
- Source: drugdu
- 33
- September 17, 2025
Sabin strain inactivated polio vaccine approved for marketing, enriching product portfolio

　　China Securities Intelligence Financial News Kangtai Biological(300601) announced on the evening of September 15 that its wholly-owned subsidiary Beijing Minhai Biotechnology Co., Ltd. received the “Drug Registration Certificate” issued by the State Food and Drug Administration, and its developed Sabin strain inactivated polio vaccine (Vero cell) was officially approved for marketing. 　　According to the announcement, the vaccine is used to prevent acute infectious diseases caused by polio virus. After vaccination, it can stimulate the body to produce immunity against polio virus and is used to prevent poliomyelitis caused by polio type I, II and III virus infection. 　　According to the website of the National Medical Products Administration, the manufacturers of the vaccine currently on the market in China include Beijing Sinovac BiotechProducts Co., Ltd., Beijing Biological ProductsInstitute Co., Ltd., Institute of Medical Biology, Chinese Academy of Medical Sciences. 　　The announcement stated that the approval of the above-mentioned vaccines for marketing ...
- Source: drugdu
- 32
- September 17, 2025
Borrui Pharmaceuticals’ application for clinical trial of BGM0504 tablets in overweight/obese adults has been approved.

Borrui Pharmaceuticals(688166) announced on the evening of September 15th that its wholly-owned subsidiary, Borrui Pharmaceutical, recently received a “Notice of Approval for Drug Clinical Trial” from the National Medical Products Administration (NMPA), authorizing the clinical trial of Borrui Pharmaceutical’s BGM0504 tablets in overweight/obese adults. BGM0504 is a dual agonist of the GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors independently developed by the company. It activates the downstream pathways of GIP and GLP-1, resulting in biological effects such as blood sugar control, weight loss, and the treatment of non-alcoholic steatohepatitis (NASH), demonstrating potential for the treatment of various metabolic diseases. BGM0504 injection is currently in Phase III clinical trials in China for both type 2 diabetes and weight loss. BGM0504 tablets are the oral formulation of BGM0504. As of the date of this announcement, no oral formulations targeting this target have been approved for marketing globally. https://finance.eastmoney.com/a/202509153513828386.html
- Source: drugdu
- 32
- September 17, 2025
Novo Nordisk’s Rybelsus Becomes First EU Approved Oral GLP-1 Reducing Severe Cardiovascular Events

Novo Nordisk announced the European Medicines Agency’s Committee for Medicinal Products for Human Use approved an update for Rybelsus’ label now displaying its cardiovascular benefits discovered in the Phase 3b SOUL trial. “Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life, and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, international operations at Novo Nordisk. Larsen continued, saying,“This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.” Rybelsus’ next steps Novo Nordisk is planning on sharing the full results from the GLP-1’s Phase 3b SOUL trial later this week at the European Association for the Study of Diabetes’ (EASD) 2025 Annual Meeting, running from ...
- Source: drugdu
- 40
- September 17, 2025
Triple Dose Of Ozempic Safe, More Effective For Weight Loss

By Dennis Thompson HealthDay ReporterTUESDAY, Sept. 16, 2025 (HealthDay News) — A triple-sized weekly dose of Ozempic works better to help people with obesity shed excess pounds without significant side effects, new clinical trial results show. Obese folks lost more weight taking 7.2 mg of semaglutide (Ozempic/Wegovy) a week than those taking either the currently approved dose of 2.4 mg or a placebo, researchers reported Sept. 14 in The Lancet Diabetes & Endocrinology. The results “suggest that a higher dose of semaglutide up to 7.2 mg per week could be used to achieve greater clinical benefits in people not reaching therapeutic goals with once-weekly semaglutide 2.4 mg,” concluded a team led by Dr. Sean Wharton, leader of the Wharton Medical Clinic for Weight and Diabetes Management in Ontario, Canada. Researchers tested the triple-dose of semaglutide in two clinical trials, one involving people with obesity and the other in people with ...
- Source: drugdu
- 40
- September 17, 2025
【EXPERT Q&A】Specifically, what are Class II medical devices?

Drugdu.com expert’s response: Class II medical devices refer to medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness. Below is a detailed explanation of Class II medical devices: I. Definition and Risk Level Definition: Class II medical devices are those whose safety and effectiveness should be controlled. These devices are typically used for the prevention, diagnosis, monitoring, treatment, or alleviation of diseases in human organs, tissues, or body fluids outside the body, employing various technological means and potentially posing a moderate risk to humans. Risk Level: The risk level of Class II medical devices falls between that of Class I low-risk medical devices and Class III high-risk medical devices. Class I medical devices have a low degree of risk and can be managed through routine measures to ensure their safety and effectiveness. In contrast, Class III medical devices carry a higher risk ...
- Source: drugdu
- 33
- September 17, 2025
The birth of the youngest pharmaceutical company worth hundreds of billions of yuan

The World Lung Cancer Conference (WCLC), a leading global conference in the field of lung cancer treatment, has always been a central arena for innovative pharmaceutical companies to compete. At this year’s WCLC, several innovative Chinese pharmaceutical companies made their mark, with Baili Tianheng undoubtedly the most prominent. Its core product, the world’s first EGFR×HER3 bispecific ADC drug BL-B01D1 (Iza-bren) combined with osimertinib in the treatment of EGFR-mutated non-small cell lung cancer, has achieved an objective response rate (ORR) of 100%, with far-leading efficacy data. It has also achieved a historic breakthrough of a median progression-free survival (mPFS) of over 12 months in monotherapy. As of the close of September 12, the share price of Baili Tianheng’s A shares closed at 349.79 yuan per share, and the company’s total market value exceeded 140 billion yuan, making it the third innovative pharmaceutical company in the A-share market to join the “100 ...
- Source: drugdu
- 52
- September 16, 2025
Kexing Pharma partners with Thousand Oaks Biopharmaceuticals to enter the European and American biosimilar markets

Recently, Kexing Pharma have reached a strategic cooperation with Shanghai Thousand Oaks Biopharmaceutical Co., Ltd. (hereinafter referred to as “Thousand Oaks Bio”) to jointly develop the KXBS001 biosimilar, officially entering the European and American biosimilars market. The European Medicines Agency (EMA) recently released a draft plan to streamline the review process for biosimilar drug development, potentially opening a “fast track” to the EU market for domestic pharmaceutical companies. According to an IQVIA research report, the EU, as the world’s leading biosimilar market (accounting for approximately 40% of its value), will have no corresponding biosimilars in development for approximately 71% of original biosimilars whose patents expire between 2024 and 2030, presenting a significant market opportunity. Kexing Pharma adheres to the “innovation + internationalization” strategy and has formed full-chain innovation capabilities for its antibody technology platform, with a portfolio of more than ten new drugs in the fields of antiviral, tumor, and ...
- Source: drugdu
- 44
- September 16, 2025
Zhengda Tianqing’s new drug Qinglishu approved for marketing

　　Xinhua Finance, Nanjing, September 15 (Reporter Zhu Cheng) Recently, the official website of the National Medical Products Administration showed that the injectable degarelix acetate (trademark name: Qinglishu) independently developed by China Biopharmaceutical ‘s core enterprise, Zhengda Tianqing Pharmaceutical Group, has been approved for marketing for prostate cancer patients who need androgen deprivation therapy. 　　Zhengda Tianqing’s degarelix acetate has been approved in the EU market, becoming the world’s first generic drug, and has also received provisional approval in the US. During the domestic review process, Zhengda Tianqing also launched a patent challenge, successfully invalidating two core claims of the original drug. This product also became the first drug to receive a 12-month exclusivity period since the implementation of my country’s early resolution mechanism for pharmaceutical patent disputes. 　　The early resolution mechanism for drug patent disputes, also known as the drug patent linkage system, is a mechanism to balance the development of ...
- Source: drugdu
- 40
- September 16, 2025

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