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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
- 34
- 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
- 35
- 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
- 34
- 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
- 33
- 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
- 33
- 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
- 33
- 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
- 27
- October 29, 2026
【EXPERT Q&A】‌‌What are the mandatory core requirements for NMPA registration materials of Class II active medical devices?

Drugdu.com expert’s response: When enterprises apply for domestic registration of Class II active medical devices, they need to focus on demonstrating the product’s safety, effectiveness and quality controllability. Compared with some passive medical devices, active products usually involve functions such as power supply, circuits, software, control systems and energy output. Therefore, in the registration review process, electrical safety, electromagnetic compatibility (EMC), software verification and product performance are the key areas of concern. In accordance with the Regulations on Administration of Medical Device Registration and Filing of the National Medical Products Administration (NMPA) and Announcement No. 121 of 2021, domestic Class II medical devices are subject to registration review and approval by the provincial drug regulatory department where the enterprise is located, while imported Class II medical devices are reviewed and approved by the NMPA. The registration application materials shall be prepared in accordance with the specified catalogue and format, and the technical ...
- Source: drugdu
- 60
- October 26, 2026
Rotigotine Transdermal Patch Receives Drug Registration Certificate, Expanding Its Parkinson’s Treatment Portfolio

On October 26, Fuyuan Pharmaceutical (601089) announced that it had received a Drug Registration Certificate from the National Medical Products Administration (NMPA) for its rotigotine transdermal patch (strengths: 2 mg/24 hours and 4.5 mg/patch), approving the manufacture of the product. The rotigotine transdermal patch is indicated for monotherapy of the signs and symptoms of early-stage idiopathic Parkinson’s disease, or in combination with levodopa at all stages of the disease. Rotigotine is a non-ergot dopamine receptor agonist. The transdermal patch delivers the drug continuously and steadily through the skin, helping to maintain stable plasma concentrations, reducing the peak-trough fluctuations common with oral dosing and improving morning motor symptoms. It is particularly suitable for patients with dysphagia or those requiring continuous overnight dosing. According to the announcement, the company’s cumulative R&D investment in this product amounted to RMB 15.7779 million. The approval will further enrich the company’s product pipeline and help enhance ...
- Source: drugdu
- 79
- October 26, 2026
Qilu Pharmaceutical’s Changqiping® inhaled spray approved for market launch, adding a new option for maintenance treatment of COPD

Recently, Qilu Pharmaceutical’s tiotropium bromide inhalation spray (Changqiping® ) was approved for marketing by the National Medical Products Administration. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD, including chronic bronchitis and emphysema) and related dyspnea, improving the quality of life of COPD patients and reducing acute exacerbations. This approval represents another breakthrough for the company in the high-barrier drug-device combination field, further enriching its respiratory system product pipeline and providing new treatment options for clinical practice. COPD is a heterogeneous lung disease characterized by persistent airflow limitation and corresponding respiratory symptoms. Its core pathological changes include small airway lesions and lung parenchymal destruction. The main symptoms include chronic cough, sputum production, shortness of breath, or dyspnea. In my country, the prevalence of COPD is severe, becoming one of the major chronic diseases seriously endangering national health, alongside hypertension and diabetes. The prevalence of COPD in ...
- Source: drugdu
- 81
- October 26, 2026

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