PharmaFocus Today – media

Haixi’s new drug HX9428 receives Fast Track designation from the US FDA.

Forwarding our company’s announcement dated August 17, 2026: The Board of Directors of our Company is pleased to announce that HX9428, a drug candidate molecule of our independently developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the development of a treatment for neovascular age – related macular degeneration ( nAMD, also known as wet age-related macular degeneration, wAMD) . This FTD designation will facilitate closer communication between our Company and the FDA regarding the clinical development of HX9428 and advance its global clinical development process. HX9428 is a novel oral small molecule drug independently developed by Haixi New Drug, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injection into the eye, which may lead to long-term, repeated treatments, resulting in medical ...
- Source: drugdu
- 132
- August 18, 2026
Just now, Fosun Pharma licensed 10 biosimilar drugs for overseas markets!

Just now, Fosun Pharma issued an announcement stating that its holding subsidiary, Henlius Biotech, signed a “Cooperation Framework Agreement” with Sandoz AG , which will allow Henlius Biotech to cooperate with Sandoz AG on the registration, commercialization, development, and production of up to 10 monoclonal antibody ( mAb ) and / or antibody-drug conjugate ( ADC ) biosimilar products or ingredients in relevant overseas regions . The first three collaborative products are HLX05-N , HLX16 , and belimumab biosimilars, with the collaboration scope covering the treatment of all human indications, but limited to indications approved for the original products in the relevant countries / regions of the collaboration area; one potential collaborative product (options have been granted to the collaborators) is HLXTE-HAase1001 . For the first three collaborative products, Henlius may receive up to US$314 million in upfront payments, development milestones and development budget milestones, and sales milestone payments (subject ...
- Source: drugdu
- 66
- August 18, 2026
Lunan Pharmaceutical’s Milrinone Lactate Injection Receives Marketing Approval in Malaysia

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Milrinone Lactate Injection issued by the Malaysian Food and Drug Administration ( NPRA ), marking that the product has officially obtained market access in Malaysia and can be sold and commercialized there. Milrinone lactate injection is a phosphodiesterase inhibitor with both positive inotropic and vasodilatory effects. It is a drug that rapidly improves hemodynamics and is suitable for acute and chronic refractory congestive heart failure caused by ineffective or poorly responded treatment with digitalis, diuretics, and vasodilators. Currently, milrinone lactate injection produced by Lunan Pharmaceutical has been approved for marketing in the United States, Ukraine, Costa Rica, and other countries. Furthermore, marketing applications have been submitted in more than 20 countries and regions, including Vietnam, Saudi Arabia, Brazil, and the United Kingdom. During the product’s marketing application process in Malaysia, the ...
- Source: drugdu
- 55
- August 18, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Pakistan.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate (registration number: 135844) for inhaled isoflurane issued by the Drug Regulatory Authority of Pakistan (DRAP) , marking that the product has officially obtained market access in Pakistan and can be sold and commercialized there. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia. With its advantages of rapid induction, rapid recovery, and low metabolic rate , it is widely used in various surgical procedures. Currently, this product is available in China, the United States, and Japan, and registration applications are underway in several overseas markets. The company is accelerating its global supply strategy to provide patients with a safe and effective anesthetic option. During the registration process in Pakistan, the registration team strictly adhered to local regulations, efficiently prepared technical documentation, and communicated with reviewers, leading to the successful ...
- Source: drugdu
- 59
- August 18, 2026
BMS’s new anti-tumor drug has been approved for marketing; GSK and Acyclovir are advancing clinical trials of their new drugs.

On August 13 local time , Bristol Myers Squibb ( BMS ) announced that the U.S. FDA has approved its innovative drug Iberdomide ( Zenbexus ) for marketing in combination with the standard treatment regimen (daratumumab + dexamethasone) for the treatment of relapsed or refractory multiple myeloma ( MM ) . According to the press release, Iberdomide is the first FDA -approved cereblon E3 ubiquitin ligase modulator ( CELMoD ) therapy. Iberdomide is the first product in BMS’ CELMoD pipeline. Previously, the drug received Breakthrough Therapy Designation and Priority Review designation from the FDA for the treatment of relapsed or refractory multiple myeloma. This approval is based on the results of the Phase III EXCALIBER-RRMM ( NCT04975997 ) study . This was a Phase III , multicenter, two-stage, randomized, open-label study designed to evaluate the efficacy and safety of the Iberdomide plus daratumumab and dexamethasone (ZDd) regimen versus the daratumumab, ...
- Source: drugdu
- 65
- August 18, 2026
Qilu Pharmaceutical’s Vitamin K1 Injection Approved for Marketing; Mixed Micelle Technology Enhances Drug Safety and Stability

Recently, Qilu Pharmaceutical’s Vitamin K1 injection (Changshi®) received approval from the National Medical Products Administration for marketing and is considered to have passed the consistency evaluation. This approval further enriches the company’s product pipeline in the field of anticoagulant drugs, providing new domestically produced drug options for clinical use. Qilu Pharmaceutical’s R&D personnel conduct formulation process research Normal blood clotting function is essential for maintaining human life. Vitamin K1 is an essential coenzyme for the liver to synthesize four clotting factors (II, VII, IX, and X), playing an irreplaceable core role in the body’s clotting and hemostasis processes. Clinically, excessive use of oral anticoagulants such as warfarin, obstructive jaundice, bile leakage, chronic diarrhea, or long-term use of broad-spectrum antibiotics can all lead to insufficient vitamin K synthesis or intake, causing abnormal blood clotting function, requiring timely exogenous vitamin K1 supplementation to correct the problem. Currently, there is a large number ...
- Source: drugdu
- 55
- August 18, 2026
A well-known generic drug company recalls 10 types of eye drops.

10 eye drops from Indian generic drug company Sun Pharma (see table below) were recalled “precautionarily” due to contamination risks, covering treatment areas such as glaucoma and postoperative inflammation. This marks the second time in three years that an Indian pharmaceutical company has been involved in a quality incident related to the sterility control of eye drops. In 2023, EzriCare artificial tears produced by the Indian pharmaceutical company Global Pharma Healthcare were contaminated with Pseudomonas aeruginosa, resulting in 81 infections, 4 deaths, and 14 cases of blindness in the United States . 01 “Precautionary” recall Recently, Sun Pharma officially issued a notice to its distributors across India, announcing a complete halt to sales, inventory reporting, and channel recalls of 10 of its eye drop products. These products involve multiple mainstream brands, including Depopred, Brinolar, Lotepred, and Nepalact , covering core clinical indications such as glaucoma treatment, postoperative anti-inflammatory treatment, chronic ...
- Source: drugdu
- 76
- August 13, 2026
Big news! Zhejiang pharmaceutical company targets 500 million yuan lipid-lowering blockbuster drug

Recently, the Center for Drug Evaluation (CDE) announced that the application for generic marketing of probucol tablets by Zhejiang Jiangbei Pharmaceutical Co., Ltd. has been officially accepted. This is one of the few new applications for this product since 2021. Probucol is a lipid-lowering drug with antioxidant properties, originally developed by Merck & Co. in the United States and approved by the FDA in 1977. Its most significant characteristic lies not in its lipid-lowering power, but in its unique multiple mechanisms of action: it can both lower cholesterol and slow the progression of atherosclerosis through antioxidant pathways, giving it an irreplaceable clinical role in niche indications such as familial hypercholesterolemia and xanthomas. According to data from Yaozhi, the domestic market size of probucol tablets has never been less than 400 million yuan since 2022, and reached 480 million yuan in 2025, representing a year-on-year increase of 5%. The competitive landscape ...
- Source: drugdu
- 72
- August 13, 2026
Subsidiary’s Tranexamic Acid Sodium Chloride Injection Receives Drug Registration Certificate

On August 7th, Tianjin Pharmaceutical Co., Ltd.(600488.SH) announced that its subsidiary, Hubei Jinyao, received a Drug Registration Certificate for Tranexamic Acid Sodium Chloride Injection issued by the National Medical Products Administration. This drug is mainly used for various types of bleeding caused by acute or chronic, localized or systemic primary fibrinolysis. It was registered as a Class 3 chemical drug, and its approval is considered as passing the consistency evaluation of generic drug quality and efficacy. The approval of this drug will enrich the company’s pharmaceutical product portfolio and have a positive impact on expanding the domestic pharmaceutical market and improving its performance. https://finance.eastmoney.com/a/202608073835167227.html
- Source: drugdu
- 64
- August 13, 2026
Lenvatinib Mesylate Capsules Receive Drug Registration Certificate

On August 7th, Lu Kang Pharmaceutical(600789) announced that it has obtained a Drug Registration Certificate for Lenvatinib Mesylate Capsules from the National Medical Products Administration. This approval supports the enrichment of the company’s pharmaceutical product pipeline. Lenvatinib mesylate is a tyrosine kinase receptor inhibitor indicated for patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy. Its domestic sales in 2025 and the first quarter of 2026 were RMB 649 million and RMB 419 million, respectively. The company’s R&D investment in this drug was approximately RMB 8.59 million (unaudited). In the first quarter of 2026, Lu Kang Pharmaceutical achieved revenue of 1.616 billion yuan and net profit attributable to the parent company of 53.25 million yuan. https://finance.eastmoney.com/a/202608073835349687.html
- Source: drugdu
- 137
- August 13, 2026

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