PharmaFocus Today – Page 5 – media

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
- 79
- 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
- 101
- 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
- 77
- 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
- 67
- November 3, 2026
Wolwo Pharma’s S01D Tablet Approved for Clinical Trials, a New-Mechanism Drug for Drug-Resistant Pulmonary Tuberculosis

Zhejiang Wolwo Biotech Co., Ltd. (Wolwo Pharma) recently downloaded a Clinical Trial Approval Notice from the government service portal of the National Medical Products Administration (NMPA), granting approval for the clinical trial application of its self-developed S01D tablet to conduct trials for the treatment of adult drug-resistant pulmonary tuberculosis. According to the announcement, S01D tablet is classified as a Class 1 chemical drug in tablet form with anti-Mycobacterium tuberculosis activity, intended for adult patients with drug-resistant pulmonary tuberculosis. As of the announcement date, no identical chemical drug has been approved in China or abroad. Tuberculosis treatment currently relies mainly on multidrug combination regimens, while drug-resistant tuberculosis has long faced the clinical challenges of lengthy treatment courses, poor efficacy and severe adverse reactions. As a new molecular entity with a novel mechanism of action, S01D showed superior anti-tuberculosis activity in nonclinical studies. The company is a biopharmaceutical enterprise specializing in the ...
- Source: drugdu
- 185
- November 2, 2026
Two specifications of dexketoprofen tromethamine tablets from Keruide Pharmaceuticals have been approved

Recently, Sichuan Keruide Pharmaceutical Co., Ltd. received a Drug Registration Certificate issued by the National Medical Products Administration, approving the registration of the company’s dexketoprofen tromethamine tablets (25mg and 12.5mg specifications). For patients, this means that in common mild to moderate pain scenarios such as musculoskeletal pain, dysmenorrhea, toothache, and arthritis-related pain, there is an additional option for prescription drugs and room for adjustment of dosage in clinical practice. For Keruide, this further completes its pain management product line. Dexketoprofen can be used in conjunction with the already marketed Keruide (tizanidin hydrochloride) to address pain accompanied by muscle spasms from both peripheral anti-inflammatory and central muscle relaxation perspectives, providing orthopedic, rehabilitation, and pain management doctors with a more comprehensive medication combination. I. What are the approved drugs mainly used to treat? Dextrokeprofen tromethamine tablets are primarily used for the symptomatic treatment of mild to moderate pain caused by various etiologies, ...
- Source: drugdu
- 113
- November 2, 2026
Another domestically produced biopharmaceutical has entered the European market; Qilu Pharmaceutical’s bevacizumab has been shipped to the UK.

On October 29, Qilu Pharmaceutical’s bevacizumab injection (trade name: Ankevda) was shipped to the UK, becoming Qilu Pharmaceutical’s second biological agent to enter the UK market after ranibizumab, further expanding the footprint of domestically produced biological drugs in the European market. The product received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February this year, marking Qilu Pharmaceutical’s achievement of stringent standards in high-end regulatory markets for its biopharmaceutical R&D and manufacturing quality system. Upon receiving the first order, Qilu Pharmaceutical’s international business, production, R&D, quality, registration, supply chain, and logistics departments collaborated to ensure the smooth execution of key processes, including batch production, quality release, document preparation, temperature-controlled cold chain, and customs clearance, completing all preparations for overseas commercial delivery and enabling rapid shipment. Once officially launched, the product will provide local cancer patients with new treatment options. Bevacizumab is an anti-angiogenic monoclonal antibody ...
- Source: drugdu
- 120
- November 2, 2026
Nemonoxacin malate has been approved for registration as an active pharmaceutical ingredient in marketed pharmaceutical preparations.

Nanfang Finance News, October 29th – Shijiazhuang Pharmaceutical Group (02005.HK) issued a voluntary announcement stating that the Group’s Apple…Nemonoxacin acid has been approved and registered by the China National Medical Products Administration as an active pharmaceutical ingredient for use in marketed formulations.Nemonoxacin malate is an anti-infective drug primarily used to treat community-acquired pneumonia in adults. Source: https://finance.eastmoney.com/a/202610293914204963.html
- Source: drugdu
- 76
- November 2, 2026
Vitamin B12 injection passes generic drug consistency evaluation

Nancai Intelligence News, October 30th – Haixin Co., Ltd.The announcement states that its controlling subsidiary, Jiangxi Gannan Haixin Pharmaceutical Co., Ltd., received the “Approval Notice for Supplemental Drug Application” issued by the National Medical Products Administration, authorizing the production of vitamins .B12 injection has passed the consistency evaluation for generic drug quality and efficacy. This drug is primarily used for megaloblastic anemia caused by intrinsic factor deficiency, and can also be used as an adjunct treatment for subacute combined degenerative neurological disorders. According to the Moshang Pharmaceutical Database, the sales of this drug in medical institutions and physical pharmacies in 2025 were 84.76 million yuan. Passing this evaluation will help enhance the product’s market competitiveness but will not have a significant impact on the company’s current operating performance. Source: https://finance.eastmoney.com/a/202610303916433870.html
- Source: drugdu
- 75
- November 2, 2026
Pfizer’s TALZENNA Plus XTANDI FDA-Approved for an Earlier Metastatic Prostate Cancer Treatment Setting

On October 26, Pfizer announced that the U.S. FDA has expanded approval of TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC). The approval makes the oral PARP inhibitor TALZENNA plus the androgen receptor pathway inhibitor XTANDI available in an earlier line, providing an opportunity to delay disease progression at a critical stage. The combination was first approved in the U.S. in 2023 for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval is based on the pivotal Phase 3 TALAPRO-3 study, which showed that TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% (HR 0.48; 95% CI 0.36-0.65; p<0.0001), with an estimated 77% of patients remaining progression-free at three ...
- Source: drugdu
- 140
- October 29, 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.