PharmaFocus Today – Page 3 – media

First! FDA approves Gilead’s liver therapy

On May 22, 2026, the FDA announced accelerated approval for Gilead ‘s Hepcludex (bulevirtide) injection for the treatment of chronic hepatitis D virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Screenshot source: FDAThis approval not only marks the official birth of the first treatment for chronic HDV infection in the United States, but also fills a long-standing clinical gap in the field.HDV infection occurs only in individuals infected with hepatitis B virus (HBV), and can take the form of co-infection or superinfection. Compared to HBV infection alone, co-infection with HDV accelerates the progression of liver fibrosis and significantly increases the risk of cirrhosis, hepatocellular carcinoma, and liver disease-related death .Hepcludex was approved based on data from a Phase III clinical trial called MYR301. Results showed that at week 48, patients treated with Hepcludex 8.5 mg once daily had a comprehensive response rate (significantly reduced viral load and ...
- Source: drugdu
- 58
- May 25, 2026
Lunan Pharmaceutical’s Lilin® Bortezomib for Injection has been approved for marketing and is considered to have passed the evaluation

Recently, Lilin® Bortezomib for Injection (specifications: 1.0mg, 3.5mg) produced by Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group , was approved for marketing by the National Medical Products Administration and is considered to have passed the consistency evaluation of generic drug quality and efficacy. The approval numbers are: National Drug Approval Number H20264387 and National Drug Approval Number H20264388. The active ingredient in this product is bortezomib, a reversible inhibitor of chymotrypsin-like activity of the 26S proteasome in mammalian cells. It induces tumor cell apoptosis by inhibiting proteasome function, interfering with the ubiquitin-proteasome pathway, and blocking the degradation of key signaling proteins within tumor cells. Preclinical studies have shown its significant inhibitory effect on tumors such as multiple myeloma. When used for multiple myeloma, this product can be combined with melphalan and prednisone (MP regimen) for previously untreated patients who are not suitable for high-dose chemotherapy ...
- Source: drugdu
- 53
- May 25, 2026
its shares surged over 140% at the open, with Northern Light Venture Capital and Gaotejia among its shareholders

Overcoming the challenge of antimicrobial resistance, two world-first products form a dual engine for anti-infection. On May 22, Danuo Pharmaceutical (Suzhou) Co., Ltd. (hereinafter referred to as “Danuo Pharmaceutical”) officially listed on the main board of the Hong Kong Stock Exchange with the stock code 6872.HK. The global offering consisted of 8,856,000 H shares, with an issue price of HK$75.70, raising a total of approximately HK$627 million and net proceeds of approximately HK$558 million. The IPO was jointly sponsored by CITIC Securities (25.870, 0.00, 0.00%) and ABC International. Cornerstone investors included AMR Action Fund, Yuanhe Holdings, Orient Asset Management, and Junsheng Global, who subscribed for a total of approximately 3,082,450 shares, representing 34.81% of the total global offering. The international placement portion of the IPO was oversubscribed by 9.24 times, while the Hong Kong public offering was also highly popular, recording an oversubscription of 9,015 times, ranking second in the ...
- Source: drugdu
- 56
- May 25, 2026
A single-quarter revenue of 4.4 billion! The “King of Nuclear Drugs” ignites precision treatment for prostate cancer

With quarterly sales of $642 million (approximately RMB 4.4 billion), a 70% year-on-year increase, Pluvicto, the “king of nuclear drugs,” is pushing precision treatment for prostate cancer into a new era of explosive growth with an almost overwhelming momentum. Novartis’ Q1 2026 report shows that the sales curve of this prostate cancer radioligand therapy continues to be steep: $280 million in its first year of launch in 2022, $980 million in 2023, $1.392 billion in 2024, and $1.994 billion for the whole of 2025, maintaining a growth rate of over 40% for three consecutive years , officially becoming the world’s first radiopharmaceutical product to break the $1 billion mark. Multinational giants, the “kings of nuclear medicine,” are making great strides in the prostate cancer field, while domestic innovative forces are also accelerating their progress . Hengrui Medicine’s self-developed PSMA-targeted nuclear medicine HRS-4357 has started Phase III clinical trials; Hansoh Pharmaceutical’s ...
- Source: drugdu
- 50
- May 25, 2026
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
- 109
- 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
- 116
- 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
- 82
- 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
- 65
- 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
- 100
- 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
- 90
- May 22, 2026

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