PharmaFocus Today – Page 15 – media

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
- 154
- 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
- 192
- 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
- 157
- 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
- 143
- 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
- 228
- August 13, 2026
Subsidiary’s self-developed Class 1 innovative drug, bemosubalimab injection, in combination therapy, has been approved for marketing.

　　On August 7, China Biopharmaceutical (01177) issued an announcement stating that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has independently developed a Class 1 innovative drug.Bemosubalimab injection in combination with chemotherapy followed by anlotinib hydrochloride capsules has been approved for marketing by the National Medical Products Administration of China for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer. 　　The announcement mentioned that this is the 12th approved indication for anlotinib and the 6th approved indication for bemosubib. https://finance.eastmoney.com/a/202608073835411830.html
- Source: drugdu
- 166
- August 13, 2026
Hanyu Pharmaceutical has licensed 3SBio’s Smegglutide injection to commercialize the product, with sales milestones reaching up to 145 million yuan.

On August 12, Hanyu Pharmaceutical(300199) issued an announcement stating that the company has reached an agreement with Zhejiang Sansheng Mandi Pharmaceutical Co., Ltd., and the two parties have reached a cooperation agreement on the development, registration, production and commercialization of Smegglutide injection (for blood glucose control) in China (excluding Taiwan). The company granted 3SBio an exclusive, non-transferable, and sublicensable license in the region, under which 3SBio or its affiliates shall act as the marketing authorization holder for the collaborative products in China and be solely responsible for the commercialization of the collaborative products in the region. The financial terms of this collaboration consist of three parts: an initial payment to 3SBio for signing the agreement, milestone payments for registration and commercialization, and sales royalties. The initial payment is RMB 12 million. The milestone payments for registration and commercialization include RMB 18 million upon approval of the blood glucose indication for ...
- Source: drugdu
- 194
- August 13, 2026
Is Your Product Ready for Global Markets? Drugdu.com 10th Anniversary Overseas Promotion Readiness Program

Helping pharmaceutical and medical device companies better understand their overseas promotion readiness and next growth opportunities Expanding Overseas Markets Requires More Than Having a Good Product For pharmaceutical and medical device companies, entering global markets involves more than simply listing products online or finding potential buyers. Successful overseas promotion requires companies to present their capabilities clearly, communicate product value effectively, identify suitable markets, and build trust with international buyers. However, many companies still face challenges during their overseas expansion journey: They have strong products and manufacturing capabilities but are unsure which products should be prioritized for global promotion. They already have export experience but need clearer direction on which markets and channels to focus on. They have participated in exhibitions or invested in promotion but lack continuous feedback to optimize future strategies. Before investing more resources, companies need a clearer understanding of their current overseas promotion readiness. Drugdu.com 10th Anniversary ...
- Source: drugdu
- 380
- August 13, 2026
Miraberon API Receives FDA Registration Approval

China Securities Intelligent Finance – Tonghe Pharmaceutical(300636) announced on the evening of August 11 that the company recently received Miraberon API issued by the U.S. Food and Drug Administration.The NFC Letter indicates that the FDA has completed its technical review of the company’s DMF file for the Miraberon active pharmaceutical ingredient , which meets the ANDA application requirements of related formulation customers. The announcement indicates that mirabezone is a selective β3-adrenergic receptor agonist that can improve bladder filling and storage capacity by activating β3-adrenergic receptors on the bladder detrusor muscle. Clinically, it is used to treat overactive bladder with symptoms such as urge incontinence, urgency, and frequency. The company stated that the successful technical review of Mirabelon API will facilitate market expansion and customer acquisition, and will play a positive role in further expanding the company’s international business. https://finance.eastmoney.com/a/202608113837991159.html
- Source: drugdu
- 238
- August 12, 2026
Subsidiary’s 9-valent HPV vaccine receives marketing authorization in Thailand

Shanghai Securities News, China Securities Network, August 11 – Wantai Biopharmaceutical…Disclosure regarding the company’s nine-valent HPV vaccineAnnouncement of Marketing Authorization in Thailand. The announcement states that the nine-valent human papillomavirus vaccine (Escherichia coli) independently developed by the company’s wholly-owned subsidiary, Xiamen Wantai Canghai Biotechnology Co., Ltd., has recently received approval from the Thai Food and Drug Administration. The nine-valent HPV vaccine is a preventive biological product independently developed by Wantai Biological Pharmacy Enterprise Co., Ltd.This is my country’s first and the world’s second nine-valent HPV vaccine. It is mainly suitable for women aged 9-45 and covers seven high-risk HPV types (16/18/31/33/45/52/58) and two low-risk HPV types (6/11). It can prevent diseases caused by infection with the above-mentioned human papillomavirus types. The company stated that the approval of the 9-valent HPV vaccine in Thailand marks the first overseas marketing authorization for this product, signifying that it is now qualified for export to ...
- Source: drugdu
- 206
- August 12, 2026

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