media – Page 5 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

ST Humanwell Secures German BfArM Marketing Authorization for Fentanyl Citrate Injection

News summary: On November 3, ST Humanwell reported that its 80%-owned subsidiary Yichang Humanwell had obtained German BfArM authorization for fentanyl citrate injection. Approved uses include adjunctive analgesia during anaesthesia, combination with neuroleptics, premedication and intensive-care pain management. Filed through the DCP in July 2023, the application involved approximately RMB 4 million in German registration expenditure. Authorization is valid for five years. IQVIA and Cortellis put combined 2025 sales in France, Germany, Italy, Spain and the UK at approximately USD 16 million; major manufacturers include Pfizer and Hikma. Humanwell expects the approval to support its international expansion. Source: URL: https://finance.eastmoney.com/a/202611033919644738.html
- Source: drugdu
- 119
- November 4, 2026
China Resources Double-Crane Receives Drug Registration Certificates for Injectable Isavuconazonium Sulfate and Other Products

News summary: On November 3, China Resources Double-Crane announced that it and its subsidiaries, Xi’an Jingxi Double-Crane and CR Double-Crane Xiangzhong Pharmaceutical, had received three drug registration certificates from China’s NMPA. Injectable isavuconazonium sulfate treats invasive aspergillosis, mucormycosis and related infections in adults and children aged one year or older. Sorbitol–mannitol irrigation solution is used during transurethral prostate resection and other urological procedures. Brexpiprazole tablets treat schizophrenia in adults. Source: URL: https://finance.eastmoney.com/a/202611033920320477.html
- Source: drugdu
- 72
- November 4, 2026
【EXPERT Q&A】What regulatory requirements should be noted when applying for an IVDRCE certificate for self-tested in vitro diagnostic reagents in the European Union?

Drugdu.com expert’s response: For enterprises preparing to export products such as pregnancy test strips, urine test strips, and infectious disease self-test kits to the EU, IVDR CE conformity assessment is a critical step to enter the EU market. Compared with in vitro diagnostic reagents mainly used by laboratory professionals, self-test products also need to consider whether ordinary consumers can correctly operate and interpret test results, as well as the health risks that may arise from improper use. The EU Regulation on In Vitro Diagnostic Medical Devices (EU) 2017/746, known as IVDR, has been applicable since May 26, 2022. This regulation sets requirements for the classification, performance evaluation, technical documentation, quality management system and post-market surveillance of IVD products. When enterprises apply for IVDR CE-related certificates, they need to pay special attention to the following aspects. First, it is necessary to confirm whether the product is a self-testing IVD and its ...
- Source: drugdu
- 80
- November 4, 2026
ST Nuotai’s Fulvestrant Injection ANDA Receives FDA Approval, Its First Formulation Approved in the U.S

Jiangsu Sinopep-Allsino Biopharmaceutical Co., Ltd. (stock abbreviation: ST Nuotai, 688076) recently received notice from the U.S. Food and Drug Administration (FDA) that the Abbreviated New Drug Application (ANDA) it submitted for fulvestrant injection has been granted marketing approval. Following a full technical review of the application, the FDA determined that the company’s product is bioequivalent and therapeutically equivalent to the reference listed drug. The ANDA number is 216722. The product is an injectable formulation with a strength of 250 mg/5 mL (50 mg/mL). The approved indication is for estrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women (including natural and artificial menopause) with disease recurrence during or after anti-estrogen adjuvant therapy or progression during anti-estrogen therapy; and in combination with abemaciclib for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in patients whose disease progressed following prior endocrine therapy. Fulvestrant ...
- Source: drugdu
- 118
- November 3, 2026
Another Step in Completing the Bone Metabolism Injection Puzzle

On October 29, 2026, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (603707.SH) received an ANDA approval letter (ANDA No.: 216996) from the U.S. Food and Drug Administration (FDA) for its salmon calcitonin injection, officially approving the product for marketing in the U.S. market. This marks another significant step in Jianyou’s international expansion of sterile injectable drugs and signifies the continued expansion of the company’s product portfolio targeting the high-end markets of Europe and the United States. What is salmon calcitonin injection ? Salmon calcitonin is a peptide hormone with an activity approximately 40–50 times stronger than human calcitonin. It inhibits osteoclast activity, reduces bone resorption, and regulates renal excretion of calcium and phosphorus. Its injection is mainly used clinically for: Symptomatic osteitis deformans (Paget’s disease): relieves bone pain and improves bone metabolism disorders; Hypercalcemia: Used for early intervention in critical hypercalcemia; Postmenopausal osteoporosis: For postmenopausal women who are not suitable for ...
- Source: drugdu
- 114
- November 3, 2026
A blockbuster new flu drug developed by Simcere Pharmaceutical failed to go public!

On October 28, according to the official website of the National Medical Products Administration, the Class 1 anti-influenza innovative drug, Madenoxavir tablets, jointly developed by Jiaxing Andicon Biotechnology and Simcere Pharmaceutical , received a drug notification notice that it had failed to be approved for marketing. Screenshot source: NMPA official website Madenoxavir is one of the most promising innovative anti-influenza drugs in China. Originally developed independently by Antcon Biotech, in October 2023, Simcere Pharmaceutical Group entered into an exclusive collaboration with Antcon, acquiring exclusive commercialization rights for its influenza indication in China. The failure to successfully advance its market application has once again brought this domestically produced anti-influenza drug, which was once highly anticipated, into the spotlight. The course of treatment for madenoxavir is short, requiring a single oral dose of one tablet. Madenoxavir is an innovative anti-influenza drug with global independent intellectual property rights. It belongs to the Cap-dependent ...
- Source: drugdu
- 80
- November 3, 2026
A new hepatitis B drug has terminated its clinical trials.

Recently, the U.S. FDA approved GSK’s new drug application for Hibsago (bepirovirsen), a new drug for chronic hepatitis B. This is the world’s first approved antisense oligonucleotide (ASO) drug for chronic hepatitis B. updated the status of its Phase 1 clinical trial for another hepatitis B candidate, GSK3965193 , to ” terminated ,” citing “strategic decision” as the reason. The U.S. Clinical Trials Registry also marked the project as terminated. One pipeline reached market approval, while another drug candidate abruptly halted its first human trial. What kind of R&D choices does GSK make in the hepatitis B drug race? The experiment was terminated. According to publicly available information in the clinical trial registry, this study, numbered NCT05330455 , is a phase I/IIa, multipart, randomized, double-blind, placebo-controlled first-in-human trial (FTIH) that was initiated on April 14, 2022, and enrolled 74 participants at 14 centers in 6 countries around the world. The ...
- Source: drugdu
- 76
- November 3, 2026
Tebo Biotech’s 10mg formulation receives approval, intensifying competition in the long-acting growth hormone market

Recently, Tebo Bio’s independently developed Yipei Growth Hormone Injection (trade name: Yipeisheng) 10mg specification was officially approved for marketing by the National Medical Products Administration. This is another expansion of Yipeisheng’s product portfolio, following the availability of four specifications: 2.5mg, 3.0mg, 3.5mg, and 5.0mg. On the surface, this might seem like just a routine specification update. But for long-acting growth hormone, going from 5mg to 10mg is not simply adding another line to the instructions. In recent years, with the approval of several long-acting growth hormones, “once-a-week” dosing is no longer a label exclusive to any one company. As “long-acting” gradually becomes the industry standard, the focus of competition is quietly shifting downwards—clinical evidence, dosage accuracy, specification compatibility, and the underlying formulation technology barriers. The approval of the 10mg specification has brought this change to the forefront. From 5mg to 10mg To understand the value of 10mg, we need to ...
- Source: drugdu
- 94
- November 3, 2026
CSPC Reports Positive Phase III Results for Prusogliptin Combination Therapy in Type 2 Diabetes

Southern Finance reported on November 2 that CSPC Pharmaceutical Group (01093.HK) disclosed positive topline results in a voluntary announcement for a phase III trial of its prusogliptin tablets combined with dapagliflozin and metformin in patients with type 2 diabetes. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at week 24. The triple regimen produced a significantly greater reduction than the two-drug regimen. Safety was favorable, with a comparable overall incidence of adverse events and no increase in safety risk reported. Source: URL: https://finance.eastmoney.com/a/202611023918878276.html
- Source: drugdu
- 75
- November 3, 2026
Fangsheng Pharmaceutical Receives Clinical Trial Approval for Shuangzao Anshen Granules

Fangsheng Pharmaceutical (603998) announced on November 2 that its internally developed innovative traditional Chinese medicine, Shuangzao Anshen Granules, received clinical trial approval from China’s National Medical Products Administration on October 30, 2026. The proposed indication is chronic insomnia with liver–kidney yin deficiency syndrome. Cumulative R&D spending was approximately RMB 4.61 million at disclosure, on an unaudited basis. The product has not been marketed in China or overseas. Citing the 2025 China Sleep Health Survey Report, the news article states that 48.5% of Chinese adults experience sleep problems, with a higher rate among women. For the first nine months of 2026, the company reported revenue of RMB 1.384 billion and net profit attributable to shareholders of the parent of RMB 289 million. Source: URL: https://finance.eastmoney.com/a/202611023918868557.html
- Source: drugdu
- 64
- November 3, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.