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Ruikang Trastuzumab’s overseas sales to Indian companies exceed US$1 billion

Hengrui Medicine (600276.SH) this year’s innovative drugsGoing overseas may break the record – today it announced that Ruikang Trastuzumab has been exported to an Indian multinational pharmaceutical company, with the total BD transaction amount exceeding US$1 billion. This is Hengrui Medicine ‘s fifth BD transaction this year, and the cumulative down payment for BD transactions reached this year has exceeded US$800 million. Hengrui Medicine announced today that it has signed a licensing agreement with Glenmark Specialty SA, a subsidiary of India’s Glenmark Pharmaceuticals (hereinafter referred to as GP), to license the development and commercialization rights of its independently developed antibody-drug conjugate (ADC) Ruikang Trastuzumab (SHR-A1811) project to the other party on a paid basis. The authorized area is the global market except Greater China, the United States, Canada, Europe, Japan, Russia and Central Asia. Under the agreement, Hengrui will receive an upfront payment of US$18 million and will be eligible ...
- Source: drugdu
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- September 25, 2025
CPHI Middle East

Organiser: Informa Markets Time：December 8 – December 10, 2025 address：King Abdullah Rd, King Abdullah Dt., Riyadh 11564 (or Riyadh 12451), Saudi Arabia Exhibition hall：Riyadh International Convention & Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracyclines, amino acids and their derivatives, chloramphenicols, digestive system drugs, other anti-infective agents, penicillins, aminoglycosides, lincomycins, cardiovascular drugs, antiparasitic drugs, cephalosporins, macrolides, respiratory drugs, central nervous system drugs, and other Western pharmaceutical ingredients. Pharmaceutical Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, drug production equipment and technology, drug packaging equipment, drug packaging materials, drug production, cleaning, sterilization, and laboratory instrument systems. Pharmaceutical Products: Various traditional Chinese medicines, Western medicines, new drugs, specialty drugs, APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, herbal medicines, botanical and animal extracts, veterinary drugs, food ingredients and additives, etc. About CPHI Middle East： The CPHI Middle East Exhibition in Riyadh, Saudi Arabia, is the most ...
- Source: drugdu
- 102
- September 25, 2025
mRNA cancer vaccines will be put into clinical patient trials in the near future

Since the pandemic, scientists have been working hard to apply mRNA technology to cancer treatment, and now there are new progresses. According to the latest news on Tuesday, Ginzburg, director of the Russian “Gamaleya” National Research Center for Epidemiology and Microbiology, said at a roundtable that Russia’s domestically produced individualized cancer vaccine is ready and will be used to treat the first Russian patients after regulatory approval. “All documents were submitted to the Ministry of Health some time ago, and we hope that in the near future, the Herzen Institute, the Blochin Institute and our institute will be able to obtain permission to produce the first individualized vaccines (for melanoma),” Ginzburg said. Accordingly, the patient population has been formed, their individualized genetic data has been identified, and we are ready to start treating them in a month to a month and a half through joint efforts. ” As an experimental ...
- Source: drugdu
- 103
- September 24, 2025
Semaglutide China’s patent is about to expire, and Novo Nordisk is accelerating the launch of oral weight loss drugs

In 2026, the Danish pharmaceutical giantNovo NordiskThestar weight loss drug semaglutide core molecule patent is about to expire in China, at which time the drug will face a lot of competition from Chinese generics. In this context,Novo NordiskIt is actively promoting the global launch process of oral semaglutide weight loss drugs. recentlyNovo NordiskA recent Phase 3 clinical trial published in the New England Journal of Medicine (NEJM) evaluated the efficacy and safety of an investigational once-daily oral semaglutide tablet (25mg tablet). The results showed that at 64 weeks of medication, the patients in the oral semaglutide tablets 25mg group achieved an average weight loss of 16.6%, and more than one-third (34.4%) of the patients achieved a weight loss of 20% or more, and the weight loss effect was comparable to that of semaglutide injection. Novo Nordisk has submitted a new drug application to the US FDA in February this year ...
- Source: drugdu
- 201
- September 24, 2025
The company’s nine-valent HPV vaccine phase III clinical research is ongoing

Watson Bio（300142. SZ) said on the investor interactive platform on September 24 that the relevant work of the company’s nine-valent HPV vaccine phase III clinical research is continuing, and if there is substantial and phased progress in the research and development of the company’s developing vaccine, the company will disclose it in a timely manner, and please pay attention to the relevant information disclosed by the company for the follow-up progress. https://finance.eastmoney.com/a/202509243522306220.html
- Source: drugdu
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- September 24, 2025
Lincomycin Hydrochloride Injection Passes Generic Drug Consistency Evaluation

On September 23rd, Tianfang Pharmaceutical, a wholly-owned subsidiary of SINOPHARM, announced that it has received notification from the National Medical Products Administration (NMPA) that Lincomycin Hydrochloride Injection has passed the generic drug quality and efficacy consistency evaluation. This drug is primarily used to treat serious infections caused by susceptible strains of Streptococcus, Pneumococcus, and Staphylococcus. Passing the consistency evaluation will provide greater support in areas such as medical insurance payment and procurement by medical institutions, helping to enhance its market competitiveness. However, there is a risk that sales may not meet expectations due to policy and market factors. https://finance.eastmoney.com/a/202509233521233113.html
- Source: drugdu
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- September 24, 2025
【EXPERT Q&A】What regulations should be known for the international registration of medical devices?

Drugdu.com expert’s response: International Regulatory Framework and Core Requirements for Medical Device Registration I. Regulatory Systems in Major Target Markets United States (FDA) Legal Basis: Federal Food, Drug, and Cosmetic Act (FD&C Act). Risk-Based Classification: Class I (Low Risk): Examples include surgical blades and bandages. Typically requires enterprise registration and product listing; some products are exempt from 510(k). Class II (Moderate Risk): Examples include ultrasound devices and infusion pumps. Requires 510(k) submission (demonstrating substantial equivalence to a predicate device) or De Novo classification request. Class III (High Risk): Examples include cardiac pacemakers and artificial joints. Requires Pre-Market Approval (PMA) with clinical trial data and production facility inspection reports. Quality System: Must comply with FDA QSR (21 CFR Part 820), covering design controls and production process validation. Special Requirements: High-risk products require clinical trials to verify safety and efficacy; some products need animal testing data. European Union (MDR/IVDR) Legal Basis: Medical Devices Regulation (MDR ...
- Source: drugdu
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- September 24, 2025
the legendary story of ketamine

1. Ketamine, once known as a “party drug,” is now reshaping the mental health field as a “miracle antidepressant.” Its core advantage lies in its rapid onset, relieving symptoms of severe depression within hours. This drug is particularly revolutionary for patients with treatment-resistant depression (TRD) who are resistant to traditional medications and those experiencing acute suicidal ideation. 2. Johnson & Johnson’s Spravato (esketamine nasal spray), a market pioneer, is expected to surpass $1.1 billion in sales in 2024, making it a blockbuster drug. However, its commercialization still faces three major challenges: strict regulation, high costs, and the risk of abuse. 3. In China, companies like Enhua Pharmaceutical and Hengrui Medicine are fiercely competing for the potentially safer and more effective R-ketamine. Beyond nasal sprays, companies around the world are also innovating in dosage forms like extended-release tablets. In clinical research, a team led by Dr. Wang Gang, President of Beijing ...
- Source: drugdu
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- September 23, 2025
Clinical trial of combination therapy with new weight loss drug ASC47 achieves positive results

Ascletis Pharmaceuticals-B (01672) announced on the morning of September 22nd that its weight-loss without muscle-loss drug candidate, ASC47, combined with semaglutide, achieved positive results in a clinical trial in obese subjects. On day 29, the 30mg ASC47 plus semaglutide group demonstrated a 56.2% improvement in weight loss compared to semaglutide alone. The study, conducted in the United States, enrolled 28 obese subjects. Results showed that the combination of ASC47 and semaglutide significantly improved gastrointestinal tolerability compared to semaglutide alone, with a 6.7% incidence of vomiting in the combination group compared to 57.1% in the semaglutide alone group. Furthermore, the ultra-long-acting subcutaneous depot formulation of ASC47 resulted in less weight regain after discontinuation, supporting the potential use of once-monthly ASC47 as a maintenance therapy for weight loss. The study also showed that the 30mg and 60mg ASC47 groups significantly reduced low-density lipoprotein cholesterol compared to the semaglutide monotherapy group. ASC47 has ...
- Source: drugdu
- 119
- September 23, 2025
Huadong Medicine：Subsidiary ADC innovative drugClinical trial approved by the US FDA

On September 22, Huadong Medicine announced that its wholly-owned subsidiary, Zhongmei Huadong, received notification from the U.S. Food and Drug Administration (FDA) that Zhongmei Huadong’s clinical trial application for HDM2017 for injection has been approved by the FDA for Phase I clinical trials in the United States for the treatment of advanced malignant solid tumors. HDM2017 for injection is a novel antibody-drug conjugate (ADC) targeting cadherin 17 (LI-cadherin). Comment: The approval of the US clinical trial application for HDM2017 for injection marks another important step forward in the product’s development and will further enhance Huadong Medicine ‘s core competitiveness in oncology treatment. However, clinical trials inherently carry risks and uncertainties, and investors should carefully monitor subsequent results. https://finance.eastmoney.com/a/202509233520253862.html
- Source: drugdu
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- September 23, 2025

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