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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
- 22
- 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
- 25
- 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
- 60
- 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
- 92
- 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
- 92
- 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
- 72
- October 29, 2026
Following a collective trading halt, MicroPort Medical officially announced a change in leadership!

Recently, MicroPort Medical Sciences Co., Ltd. (hereinafter referred to as “MicroPort Medical”) officially announced a series of senior personnel changes. According to the announcement, the company’s founder has stepped down from his position as director and related positions, remaining as Chief Scientific Officer. At the same time, the board of directors has appointed a senior veteran within the company as Executive Director and CEO. Currently, the above-mentioned personnel adjustments have fully taken effect. Trading suspension turmoil New coach takes office The underlying reason for this series of high-level personnel turmoil stems from the suspension of trading of MicroPort Medical Systems Co., Ltd. On September 1st, trading in four Hong Kong-listed companies—MicroPort Medical, MicroPort Robotics, MicroPort CardioFlow, and MicroPort Brain Science—was simultaneously suspended. While the immediate trigger was the failure to disclose their 2026 interim results on schedule, the root cause of the delay pointed to audit and accounting matters related ...
- Source: drugdu
- 82
- October 29, 2026
What new growth signals did Hengrui Medicine release in the third quarter?

In 2026, China’s innovative drug industry continued to enter a new phase of commercializing innovative achievements. Data from the National Medical Products Administration shows that 76 innovative drugs were approved for marketing in China in 2025, a record high; in the first half of 2026, another 38 innovative drugs were approved. As more innovative products enter the market, the focus of industry competition is gradually shifting from the accumulation of R&D pipelines to product commercialization, profitability, and sustainable growth capabilities. For Hengrui Medicine, what’s more noteworthy than its current performance is who will take over the next round of growth. On one hand, some of its earlier-marketed innovative drugs face increasingly fierce market competition; on the other hand, new products, new indications, and global collaborations are making continuous progress. Amidst the transition between old and new growth drivers, can Hengrui unlock new growth opportunities? Significant quarter-on-quarter growth, What new signals ...
- Source: drugdu
- 73
- October 29, 2026
Sorapinib Receives Orphan Drug Designation from the U.S. FDA

Nanfang Daily News, October 29th – Hutchison MediPharma (00013.HK) issued a voluntary announcement stating that its sorbipinib has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary immune thrombocytopenic purpura (PETP). Solepinib is a novel, highly selective oral spleen tyrosine kinase inhibitor. If approved, the drug will be eligible for seven years of market exclusivity in the U.S. from the date of approval, and will be eligible for various development incentives, including tax credits. In addition, two new drug applications for sorbipinib in China, for the treatment of PETP and warm antibody-type autoimmune hemolytic anemia, are currently under review. Source: https://finance.eastmoney.com/a/202610293913017516.html
- Source: drugdu
- 81
- October 29, 2026
Positive topline results from the US Phase II study of ASC30 for the treatment of type 2 diabetes

Ascletis Pharma announced on the 29th that it has achieved positive top-line results in its Phase II US study evaluating the oral small-molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of type 2 diabetes. This Phase II study was a 13-week US study designed to evaluate the efficacy, safety, and tolerability of once-daily oral ASC30 tablets in 100 diabetic subjects. Regarding the primary endpoint, ASC30 achieved a statistically significant and clinically meaningful reduction in glycated hemoglobin (HbA1c) in diabetic subjects compared to placebo (p < 0.0001). Based on the efficacy estimand, at week 12, the placebo-adjusted reduction in HbA1c from baseline (least squares mean) was 1.7%, 1.6%, and 1.7% in the 40 mg (n=20), 60 mg (n=29), and 80 mg (n=28) dose groups, respectively. The baseline mean HbA1c was 8.3%. Source: https://finance.eastmoney.com/a/202610293912992532.html
- Source: drugdu
- 75
- October 29, 2026

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