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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
- 51
- 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
- 43
- 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
- 46
- 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
- 41
- 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
- 43
- November 2, 2026
【EXPERT Q&A】What exactly are the General Safety and Performance Requirements (GSPR) that medical devices must meet to obtain the EU CE marking?

Drugdu.com expert’s response: When medical device enterprises prepare to enter the EU market, they often come into contact with requirements such as CE marking, MDR regulations, technical documentation and GSPR. Among them, GSPR is a particularly critical part of technical documentation preparation and product conformity assessment. Some enterprises have already obtained the ISO 13485 quality management system certification and completed product performance tests, but when preparing EU MDR technical documents, they find that they still need to explain item by item how their products meet GSPR requirements. So what exactly is GSPR? What is its relationship with CE certification and product standards? GSPR refers to the general safety and performance requirements for medical devices in the EU. Its full English name is General Safety and Performance Requirements, which are specified in Annex I of the EU Medical Device Regulation (EU) 2017/745 (MDR). To put it simply, the EU requires that ...
- Source: drugdu
- 39
- November 2, 2026
【EXPERT Q&A】What issues should the supplier pay attention to when the buyer requests the last three batches of COA?

Drugdu.com expert’s response: When exporting APIs, pharmaceutical intermediates and pharmaceutical excipients, suppliers often encounter situations where overseas buyers request a COA (Certificate of Analysis). Some customers only ask for one COA to gain a preliminary understanding of product quality, while others, after confirming product specifications, further express their wish to review the COAs of the latest three batches. For suppliers, a single COA is usually easy to provide, but consecutive three batches of COAs involve actual test data from different production batches, which requires more careful preparation. Why do buyers want to see three batches? Does it mean their procurement intention is relatively clear? If there are differences in the test results of different batches, will it affect the buyer’s judgment? These problems are very common in overseas procurement of pharmaceutical products such as APIs. Why do buyers request the COAs of the latest three batches? For pharmaceutical enterprises with ...
- Source: drugdu
- 67
- October 30, 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
- 99
- October 29, 2026
Chipscreen’s NW001, the World’s First Epigenetic Immune-Modulating Antibody Conjugate, Approved for Clinical Trials

Chipscreen Biosciences’ investigational NW001 for injection has officially received the Clinical Trial Approval Notice from the National Medical Products Administration (NMPA) for the treatment of advanced malignant tumors, including solid tumors and lymphomas. The news was released by Chengdu Hi-Tech Zone on October 28. NW001 is the world’s first Epigenetic Immune-Modulating Antibody Conjugate (EIMAC). Its antibody moiety is a humanized anti-PD-L1 monoclonal antibody, conjugated through a proprietary design with a newly optimized HDAC inhibitor (HDACi) payload. Mechanistically, NW001 binds to PD-L1 on the cell surface, is internalized, and then cleaves intracellularly to release a highly potent small-molecule HDACi payload, exerting combined epigenetic and immune anti-tumor activity. It may offer a next-generation treatment pathway for tumors refractory to immunotherapy. The program is developed in collaboration with Chengdu Chipscreen Xinyu Biotechnology, an affiliate of Chipscreen. Under the agreement, Chengdu Chipscreen will in principle become the Marketing Authorization Holder (MAH), Chipscreen Biosciences will ...
- Source: drugdu
- 97
- October 29, 2026
Dongyangguang Pharmaceutical aims to be the first generic drug.

According to the CDE website, Dongyangguang Pharmaceutical’s application for generic version of Xinuo amino acid tablets has been accepted as a Class 4 generic drug. So far this year, Dongyangguang Pharmaceutical has six products under review for approval. Sinuosine tablets are used to treat focal seizures (partial seizures) in adults, especially for patients who do not respond to or cannot tolerate conventional antiepileptic drugs (ASM). In recent years, the sales volume of antiepileptic drugs in China’s three major terminals and six major markets (see the end of this article for the statistical scope) has exceeded 7 billion yuan, with a slight year-on-year decline in the first half of 2026. In terms of administration routes, the market share of oral medications continues to expand, accounting for more than 90% in the first half of 2026. Levetiracetam tablets, sodium valproate extended-release tablets (I), and lamotrigine tablets are the top three products. According ...
- Source: drugdu
- 79
- October 29, 2026

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