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Boehringer Ingelheim’s new oral drug “Zonaitinib” has been approved for a new indication in China

On May 21, Boehringer Ingelheim and Sino Biopharmaceutical jointly announced that zongertinib tablets have been approved by the National Medical Products Administration (NMPA) of China for first -line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 ( ERBB2 ) tyrosine kinase domain activating mutations. Zongertinib is an oral HER2 tyrosine kinase inhibitor. This approval follows the NMPA’s Center for Drug Evaluation (CDE) granting the product Breakthrough Therapy designation for first-line indication and its NMPA approval for the treatment of previously treated patients in August 2025. Zonaitinib tablets are an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2) while preserving wild-type EGFR , thereby helping to reduce related toxic reactions. The incidence of HER2 mutations in non-small cell lung cancer is approximately 2%-4%. These mutations are more common in women, non-smokers, patients with lung adenocarcinoma, and younger individuals. These tumors ...
- Source: drugdu
- 37
- May 22, 2026
Class 1 innovative drug Fazanleisen tablets approved

On May 21, the National Medical Products Administration announced on its official website that Fazanleisen tablets (trade name: Mengping), a Class 1 innovative drug applied for by Jiangsu Coast Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yangtze River Pharmaceutical Group, has been officially approved for marketing. It is used to treat adult patients with insomnia who have difficulty falling asleep and/or maintaining sleep.The launch of this first domestically produced dual orexin receptor antagonist not only provides a new option for the huge population suffering from insomnia, but also marks a key milestone in Yangtze River Pharmaceutical’s transformation from a generic drug giant to an innovative drug company, and lays the groundwork for reshaping the domestic insomnia drug market. Insomnia has become a prevalent chronic disease. Data shows that by 2025, more than 500 million people in China will suffer from sleep problems. Long-term insomnia can easily lead to problems in ...
- Source: drugdu
- 37
- May 22, 2026
Shijiazhuang Pharmaceutical Group’s budesonide enteric-coated capsules approved! This poses a challenge to generic drug manufacturers, weakening the original drug’s competitive advantage.

On May 21, CSPC Pharmaceutical Group announced that its budesonide enteric-coated capsules (4mg) have officially received registration approval from the National Medical Products Administration. The approval of this drug for treating primary immunoglobulin A nephropathy (IgAN) may seem like just a generic drug, but it could break through the three-year patent protection barrier of the original drug, Everest Medicines’ “Nexocon,” and completely change the landscape of the domestic IgA nephropathy drug market. Image source: Shijiazhuang Pharmaceutical Group announcement As the world’s first causal treatment drug for IgA nephropathy, Nefucon has performed brilliantly in the Chinese market since its launch in 2024, with sales reaching 353 million yuan that year. After being included in the national medical insurance program, its market size has further expanded, with sales climbing to 1.44 billion yuan in 2025, becoming a core pillar of the company’s revenue. Supporting the exclusive market rights of this drug is ...
- Source: drugdu
- 32
- May 22, 2026
Two world-first drugs from Chipscreen Biosciences have been launched in the Macau market, further improving patient accessibility!

Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as “Chipscreen Biosciences”, stock code: 688321.SH) has officially received approval from the Drug Administration of Macao Special Administrative Region (ISAF) for the marketing of its independently developed original drug, Shuangluoping® ( Sitagliptin tablets). Previously, Epus® ( Chidamide tablets) was approved for marketing in Macao in January this year. Sitagliptin, a blockbuster product in the company’s metabolic field, has received marketing authorization for the first time in a market outside mainland China. This marks the company’s expansion of its internationalization process into the vast metabolic disease market, following the successful export of its oncology products. Macau, as an important bridge between China and Portuguese-speaking countries, will lay a solid foundation for the product’s subsequent entry into emerging markets such as Southeast Asia and South America. The successive approvals of two of Microchip Biotechnology’s first-in-class drugs in Macau not only improve accessibility for local ...
- Source: drugdu
- 36
- May 22, 2026
Beimei Prostol Eye Drops Receives Drug Registration Certificate

Xingqi Eye Drops (300573) announced on the evening of May 21 that it received the Drug Registration Certificate for Bemiprost Eye Drops issued by the National Medical Products Administration (hereinafter referred to as “NMPA”) on the same day. This product is an eye drop formulation with bimeprost as the active ingredient. Two specifications have been approved: a 0.03% (0.4ml: 0.12mg) single-dose eye drop without antibacterial agents and a 0.03% (3ml: 0.9mg) multi-dose eye drop. Both specifications are indicated for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension. The original drug already imported into China is the multi-dose product containing antibacterial agents. To date, in addition to this product, one similar single-dose generic and two multi-dose generic drugs have been approved for marketing in China. Xingqi Eye Drops stated that due to the high-tech, high-risk, and high-value-added characteristics of pharmaceutical products, the future market sales of drugs may ...
- Source: drugdu
- 34
- May 22, 2026
Mörnik® and Zhende Medical have formed a joint venture to expand accessibility of advanced wound care solutions in China.

Photo caption: On May 21, 2026, representatives from Mönchengladbach and Zhende Medical attended the signing ceremony. From left to right: Moatassem Bassiouni, Executive Vice President of Global Corporate Strategy, Business Development and Mergers & Acquisitions at Mönchengladbach; Anders Anderson, Executive Vice President of Global Wound Management at Mönchengladbach; Lu Jianguo, Chairman of Zhende Medical; Xu Dasheng, Director, Executive Vice President and CEO of Zhende Medical. Gothenburg, Sweden and Shanghai, China, May 21, 2026 – Mövenpick®, a world-leading provider of medical solutions and advanced wound care solutions, and Zhende Medical, a leading Chinese supplier of medical dressings and infection control solutions, today announced the formation of a joint venture to accelerate the expansion of their advanced wound care product portfolio in China and capitalize on the opportunities presented by one of the world’s fastest-growing markets. The joint venture, majority-owned by Mövenpick, will integrate the two companies’ advanced wound care product portfolios ...
- Source: drugdu
- 32
- May 22, 2026
【EXPERT Q&A】What Are the Specific Requirements for Equivalence Demonstration Under the EU MDR?

Drugdu.com expert’s response: EU MDR stipulates in Annex XIV that if a manufacturer wishes to cite the clinical data of a marketed device (predicate device) to support its own clinical evaluation, it must first prove equivalence between the two devices. MDR assesses this on a dimension-by-dimension basis across technical characteristics, biological characteristics, and clinical characteristics, and the overall requirements are significantly stricter than the old MDD regulation. The core principle is: the two devices must be “used under similar conditions”, meaning there are no significant clinical differences in safety and clinical performance. I. Technical Characteristics MDR requires the manufacturer to prove that the two devices are highly similar in terms of technology, with the core being “used under similar conditions.” The specific items to compare include: Design and specification performance: The design principles and physical/chemical properties should be similar. Key performance parameters such as energy intensity, tensile strength, viscosity, surface characteristics, wavelength, ...
- Source: drugdu
- 32
- May 22, 2026
Akeso Biopharma achieves another milestone! Kaducilinemab enters the colorectal cancer treatment market.

On May 18, 2026, according to the CDE website, Akeso Biopharma’s clinical trial application for cantulimab injection, submitted under registration category 2.2, was implicitly approved. The proposed indication is: neoadjuvant/adjuvant therapy with AK104 monotherapy for resectable, highly microsatellite unstable (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This signifies that this world’s first PD-1/CTLA-4 bispecific antibody drug is officially launching its assault on the perioperative treatment of colorectal cancer. Cartunib is Akeso Biopharma’s first independently developed bispecific antibody drug. It simultaneously blocks the interaction between PD-1 and its ligands PD-L1/PD-L2, and CTLA-4 and its ligands B7.1/B7.2, relieving immunosuppression in both signaling pathways and efficiently activating tumor-specific T cells, thereby exerting a synergistic anti-tumor effect. This “one drug, two targets” design achieves synergistic anti-tumor effects while significantly reducing toxic side effects compared to traditional immunotherapy combinations, achieving an optimized balance between efficacy and safety. Since its initial approval in June 2022, ...
- Source: drugdu
- 48
- May 21, 2026
AstraZeneca reports more good news

The hypertension drug market had been devoid of truly new mechanisms for many years. On May 18th, AstraZeneca’s Baxdrostat was approved for marketing in the United States, breaking this stagnation. As the world’s first aldosterone synthase inhibitor , it is not just a new drug, but a fundamental reshaping of the underlying logic of hypertension treatment. 01 Unraveling the “deadlock” of refractory hypertension Hypertension, as one of the most prevalent chronic diseases globally, has become the leading risk factor for cardiovascular and cerebrovascular diseases. Refractory hypertension, in particular, is the most challenging subtype, long troubling clinical diagnosis and treatment. According to the “Chinese Guidelines for the Prevention and Treatment of Hypertension (2023 Edition),” refractory hypertension refers to a condition where, despite lifestyle modifications, patients regularly take three or more antihypertensive drugs with different mechanisms of action (including diuretics), each at its maximum tolerated dose, and continue treatment for at least ...
- Source: drugdu
- 48
- May 21, 2026
A rising star in innovative drugs has had its product’s marketing application accepted.

According to the official website of the Center for Drug Evaluation of the National Medical Products Administration, the marketing application of Huadao (Shanghai) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Huadao Bio”) for its first Class 1 new drug, Wanji Aolunsai Injection, has been accepted . This drug is used to treat refractory and relapsed non-Hodgkin lymphoma. According to Insight database, Wanji Aolensai Injection was first applied for clinical trials in May 2018, and the first clinical trial results were announced five months later. This is the first marketing application for the drug. Currently, several CAR-T products have been approved for marketing globally. According to publicly available information, the average international price of these marketed products exceeds US$400,000, while the average domestic price is approximately RMB 1.2 million. These prices significantly exceed the out-of-pocket payment capacity and the affordability of medical insurance reimbursement for Chinese patients. Driven by the simple ...
- Source: drugdu
- 39
- May 21, 2026

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