PharmaFocus Today – Page 4 – media

Hybio Pharmaceutical’s Subsidiary Obtains Registration Certificate for Carboprost Tromethamine Injection, Deemed Passed Consistency Evaluation | Approval Alert

On September 7, Hybio Pharmaceutical (300199.SZ) announced that its wholly-owned subsidiary Gansu Chengji Biopharmaceutical Co., Ltd. has recently received the “Drug Registration Certificate” for Carboprost Tromethamine Injection (Certificate No.: 2026S03186) issued by China’s National Medical Products Administration (NMPA), with the drug approval number Guo Yao Zhun Zi H20265776 and specification of 1ml:250μg (calculated as C₂₁H₃₆O₅). Carboprost Tromethamine Injection is a prostaglandin prescription drug, classified as chemical drug Class 4, mainly used for the treatment of postpartum hemorrhage caused by uterine atony. According to relevant review principles, the drug is deemed to have passed the generic drug quality and efficacy consistency evaluation upon market approval. Postpartum hemorrhage is the leading cause of maternal death worldwide, and carboprost tromethamine, as a first-line drug for treating atonic postpartum hemorrhage, has stable clinical demand. Hybio Pharmaceutical stated that this certificate enriches the company’s product pipeline in the obstetrics and gynecology field, will enhance the ...
- Source: drugdu
- 93
- September 8, 2026
First in China! Hualan Vaccine’s Novel Influenza mRNA Vaccine Approved for Clinical Trials | Clinical Progress

On September 7, Hualan Vaccine (301207.SZ) announced that it has received the “Drug Clinical Trial Approval Notice” for its novel influenza virus mRNA vaccine from China’s National Medical Products Administration (NMPA). The vaccine is classified as a preventive biological product Class 1.2, and is approved for clinical trials to prevent influenza caused by vaccine-related influenza virus strains. Hualan Vaccine becomes the first company in China to obtain implied clinical trial approval for a novel influenza mRNA vaccine. The vaccine adopts the mRNA technology route, delivering mRNA encoding influenza virus-related antigens to express corresponding antigens in vivo and induce immune responses. From CDE acceptance on June 22 to clinical approval, it took only two and a half months, significantly faster than traditional vaccines. There are currently no influenza mRNA vaccine products on the market in China. As a leading enterprise in China’s influenza vaccine sector, Hualan Vaccine’s quadrivalent influenza vaccine consistently ...
- Source: drugdu
- 99
- September 8, 2026
The “King of Medicine” in Guangdong sold for 56.6 billion yuan.

The period from 2016 to 2025 marks a decade of continuous reform in China’s pharmaceutical industry. Centralized procurement policies are reshaping the industry’s logic, and a wave of innovative drugs is surging forward. In this profound industrial transformation, Guangdong’s pharmaceutical companies have delivered a remarkable performance . the rise of Guangdong’s “King of Medicines” from the perspectives of enterprise and brand dimensions, based on the terminal sales data of Guangdong pharmaceutical companies and drug brands from 2016 to 2025, using data from Yaozhi Data . Note: The drugs mentioned in this article cover various types of drugs, including innovative drugs, generic drugs, and traditional Chinese medicines; sales data comes from Yaozhi Data; the sales figures are based on the sales performance of pharmaceutical companies registered in Guangdong (including 21 prefecture-level cities) across the country in terms of terminal sales (hospitals + retail + e-commerce channels). 01 The King of Pharmaceutical ...
- Source: drugdu
- 93
- September 8, 2026
The snoring of 1 billion people can finally be cured! The FDA has accepted the marketing application for a new oral drug for obstructive sleep apnea.

If all goes well, a new drug for snoring will be approved early next year, potentially becoming the world’s first landmark drug targeting the neuromuscular causes of snoring . In July, Phase III clinical data of AD109 , a new oral drug for obstructive sleep apnea ( OSA ), was published in the American Journal of Respiratory and Critical Care Medicine . The data showed that the apnea-hypopnea index (AHI) decreased by 44.1% after treatment , and the oxygen depletion index and blood oxygen saturation were improved, indicating a significant improvement in the severity of OSA. picture AD109, developed by the US biotechnology company Apnimed , consists of the marketed drug atomoxetine and a novel isomer, R -oxybutynin , derived from the older drug oxybutynin. It works by modulating nerve signals, allowing patients to maintain airway tone during sleep and reducing the occurrence of sleep apnea. Its new drug application ...
- Source: drugdu
- 100
- September 3, 2026
Biosimilar Export Accelerates! Jianyou’s Adalimumab Receives FDA Approval for Additional Manufacturing Site | Overseas Expansion News

On September 1, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. (Jianyou, 603707.SH) announced that its subsidiary, Emerge Bioscience Pte. Ltd., recently received a letter from the U.S. Food and Drug Administration (FDA) approving an additional manufacturing site for adalimumab injection (40 mg/0.8 mL, single-dose) under BLA No. 761216. The approval authorizes production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility. Adalimumab injection, a biosimilar, was first approved by the U.S. FDA on December 17, 2021. Its indications cover multiple autoimmune diseases including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. The approval of the additional Nanjing manufacturing site further strengthens the product’s supply chain capabilities, providing more stable supply assurance for the U.S. market. Jianyou is an integrated pharmaceutical group focusing on R&D, production, and sales, with core business centered on heparin API and formulation supply. It has over 80 ...
- Source: drugdu
- 112
- September 3, 2026
Beyond Glycemic Control! Lilly’s Tirzepatide Receives FDA Approval for Cardiovascular Risk Reduction | Approval Alert

On September 1, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) has officially approved tirzepatide (brand name: Mounjaro) for a new indication to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, in adults with type 2 diabetes at high risk for these events. With this approval, tirzepatide becomes the world’s first GIP/GLP-1 dual receptor agonist approved for this indication. Tirzepatide is an innovative dual-target metabolic drug that simultaneously activates GLP-1 and GIP receptors, offering multiple benefits including potent glycemic control, weight loss, and improvement of metabolic disorders. It was previously approved overseas for type 2 diabetes glycemic control and adult obesity or overweight management, with continuously expanding clinical applications. This cardiovascular protection indication approval is supported by data from the large-scale Phase 3 SURPASS-CVOT study involving over 13,000 participants, fully validating the drug’s cardiovascular benefit in diabetes ...
- Source: drugdu
- 115
- September 3, 2026
First New Therapy in Nearly 30 Years! FDA Approves Besremi for Essential Thrombocythemia | Approval Alert

On September 1, the U.S. Food and Drug Administration (FDA) approved PharmaEssentia’s Besremi (ropeginterferon alfa-2b) for adults with essential thrombocythemia (ET). This marks the first new FDA-approved treatment for ET in nearly 30 years. Essential thrombocythemia is a type of myeloproliferative neoplasm in which the bone marrow produces too many platelets, increasing the risk of potentially serious blood clots, including strokes, heart attacks, and pulmonary embolisms. Some patients may also experience abnormal bleeding or an enlarged spleen. Besremi is a long-acting interferon therapy previously approved for polycythemia vera (PV), another myeloproliferative neoplasm characterized by overproduction of red blood cells. This expanded approval allows use of Besremi in adults with ET regardless of disease status or genetic subtype, including newly diagnosed patients who have not previously received cytoreductive therapy. The approval is based on results from the global Phase 3 SURPASS-ET study, which compared Besremi with anagrelide in ET patients who ...
- Source: drugdu
- 103
- September 3, 2026
Filling Domestic Gap! Hengrui’s First Long-Acting Insulin Ruihengying® Launches Online on Sept 1 | Industry News

On September 1, Hengrui Pharmaceuticals’ self-developed Class 1 innovative biologic, insulin degludec injection (brand name: Ruihengying®), officially launched on the Ali Health platform. This product is the first domestically developed long-acting insulin analog in China, indicated for the treatment of adult type 2 diabetes. From receiving NMPA marketing approval at the end of July to online launch, it took only one month, which industry observers say reflects the accelerating flow of innovative drugs from regulatory approval to patient access in China. Insulin degludec injection (development code: INS068) is a long-acting basal insulin with durable and stable action, with cumulative R&D investment of approximately 544 million yuan. Two pivotal Phase III clinical studies showed that for Chinese type 2 diabetes patients, the drug’s glycemic control is comparable to insulin glargine, with a lower risk of nocturnal hypoglycemia than the comparator, directly addressing a long-standing clinical pain point and better meeting the ...
- Source: drugdu
- 96
- September 3, 2026
Eli Lilly’s new acquisition

Lilly recently announced a definitive agreement to acquire biotechnology company Merida Biosciences for up to $2.875 billion. The transaction includes upfront payments and potential milestone payments and is expected to close in the fourth quarter of 2026. Founded in 2022 and headquartered in the United States, Merida Biosciences completed a $121 million Series A funding round in 2025. The company is developing engineered biologics with a specific antigen at one end of its molecular structure that binds to pathogenic antibodies, and an engineered Fc fragment at the other end that mediates endocytosis and degradation by hepatocytes, thereby selectively clearing pathogenic autoantibodies while preserving normal immune function. This mechanism targets antibody-driven autoimmune diseases and allergic diseases. Merida’s first pipeline product, MER511, is currently in Phase I clinical trials for the treatment of Graves’ disease and thyroid eye disease. Graves’ disease is an autoimmune thyroid disorder affecting approximately 3 million people in ...
- Source: drugdu
- 101
- September 2, 2026
World’s First Oral IL-23R Peptide Drug! Janssen’s Icotrokinra (艾特雅®) Approved in China for Psoriasis | Approval Alert

On August 27, 2026, Johnson & Johnson announced that its interleukin-23 (IL-23) receptor antagonist icotrokinra (艾特雅®, 盐酸伊可白滞素片) has been officially approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older weighing at least 40 kg. Icotrokinra is the first and currently only targeted oral peptide drug that precisely blocks the IL-23 receptor. The Center for Drug Evaluation of the NMPA granted it priority review qualification in November 2025. In four Phase III clinical studies enrolling a total of 2,500 patients, icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile. In the head-to-head superiority study, approximately 70% of patients achieved complete or almost complete skin clearance (IGA 0/1) at Week 16, and 55% achieved a Psoriasis Area and Severity Index improvement of ...
- Source: drugdu
- 135
- September 2, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.