Kelun Pharmaceutical’s oral disintegrating film for sildenafil citrate (50mg/25mg), submitted as a Class 3 chemical drug, has been officially approved for marketing. This not only means that the first company in China to launch this new dosage form of the drug, but also that Kelun Pharmaceutical has become the “first generic manufacturer of sildenafil citrate oral disintegrating film in China” with this approval, and is regarded as the first company to pass the consistency evaluation. In the fiercely competitive market of andrology drugs, sildenafil, a “super product” with its own built-in traffic, has always been a battleground for companies. According to data from PharmNet, the domestic sildenafil market has maintained a high scale in recent years, with total sales reaching 6.6 billion yuan in 2023 and remaining at a massive 6.3 billion yuan in 2024. Faced with such a huge market worth tens of billions of yuan for treating erectile ...
According to recent foreign media reports, GE Healthcare announced that it has completed the previously announced acquisition of Inteleraad for $2.3 billion (approximately RMB 15.87 billion). GE Healthcare officially announced last November that it would acquire Inteleraad for $2.3 billion. Inteleraad, founded in 1999, reportedly possesses imaging software and digital enterprise workflow solutions, and has a significant presence in the outpatient healthcare field. According to data from Yaozhi Medical Devices, Inteleraad currently has several marketed products in the United States. Of particular note is Inteleraad’s ability to provide cloud-first products designed specifically for radiology and cardiology, covering both inpatient and outpatient medical environments. This is a major reason why GE Healthcare was willing to acquire Inteleraad for a hefty sum. With the completion of the transaction, Intelerad will operate as part of GE Healthcare’s medical imaging business, and GE Healthcare expects Intelerad to continue serving enterprise imaging solutions customers in ...
Recently, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, received an “Acceptance Notice” from the National Medical Products Administration. The drug application for marketing authorization of the company’s independently developed Class 1 new drug, Likang Kepan Capsules of Fumarate, has been accepted. The indication is: treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who still have anemia after previous treatment with C5 complement inhibitors. This is expected to bring new options for the treatment of this rare disease. Research on HRS-5965-302 This application for market approval is based on a multicenter, single-arm, open-label phase III clinical trial evaluating the efficacy and safety of Likang Kepan fumarate capsules (development code: HRS-5965) in PNH patients who still have anemia after 6 months of stable treatment with C5 complement inhibitors. The study was jointly led by Professor Shi Jun of the Institute of Hematology and Blood Diseases Hospital of Chinese ...
IN026 is a potential first-in-class mRNA therapy for refractory gout, marking the official entry of DeepBio’s independently developed mRNA-LNP platform into a new treatment category. Hong Kong, Shenzhen, and Boston, USA – March 18, 2026 – Sangfor Biotech, a clinical-stage biotechnology company focused on RNA drug development, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its mRNA drug candidate, IN026, an investigational mRNA therapy for refractory gout. Following this IND approval, the company will systematically evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in a Phase 1 clinical trial in this unmet medical need patient population. IN026 achieves systemic degradation of uric acid in vivo by delivering mRNA encoding uricase (UOX) to the liver. “Refractory gout is a disease that can severely impact patients’ mobility and quality of life. Existing treatments are often limited in their effectiveness due ...
On March 19, Baiyang Pharmaceutical (301015.SZ) announced that it plans to sign an investment agreement with Sihe Gene (Beijing) Biotechnology Co., Ltd. (hereinafter referred to as “Sihe Gene”), agreeing to invest RMB 27 million in cash in Sihe Gene. After the investment, Baiyang Pharmaceutical will hold a 10% stake in Sihe Gene. Through this cooperation, Baiyang Pharmaceutical strategically secures the global priority right to acquire and commercialize all of Sihe Gene’s pipeline projects. This marks Baiyang Pharmaceutical’s official entry into the golden track of small nucleic acid therapy, opening a new chapter in its next-generation innovative therapy layout. Small nucleic acid drugs are hailed as the “third wave of pharmaceutical development” following small molecule drugs and antibody drugs. In recent years, with continuous breakthroughs in core technologies such as delivery systems and chemical modification, China’s nucleic acid drug sector is gradually emerging, becoming another golden track for innovative drugs after ...
Recently, the multispecific antibody (polyclonal antibody) pipeline has seen explosive growth, with multiple drugs entering the clinical trial stage in quick succession. Akeso Biopharma’s first triple antibody drug AK150 (ILT2/ILT4/CSF1R triple antibody) has received implied approval from the NMPA for clinical trials to treat advanced malignant solid tumors. Henlius’ next-generation TCE quadruple-specific antibody HLX3901 (DLL3 x DLL3 x CD3 x CD28 quadruple-specific antibody) has been approved for IND by the NMPA and is intended for the treatment of advanced or metastatic solid tumors. The evolution from bispecific antibodies to trispecific and quadrispecific antibodies signifies the beginning of another iteration in the antibody field, bringing both challenges and opportunities to the industry. 01 Pipeline numbers explode With the rise of molecular biology, the era of targeted therapies against single targets has arrived. Breakthroughs in monoclonal antibody technology have enabled drugs to precisely target single biological targets. However, due to the complexity ...
As the saying goes, “Good rain knows its season, and falls when spring arrives.” On March 18th, a spring rain arrived as expected, adding a unique touch to Qilu Pharmaceutical’s internationalization process. At its Jinan High-tech Production Base, Qilu Pharmaceutical’s cyclosporine ophthalmic emulsion was officially exported and shipped. This is Qilu Pharmaceutical’s first ophthalmic preparation exported to the United States, and also the company’s 39th pharmaceutical preparation to enter the US market. Cyclosporine ophthalmic emulsion is a calcineurin inhibitor and immunosuppressant. It is indicated for patients with dry eye syndrome whose tear production is suppressed due to ocular inflammation such as keratoconjunctivitis sicca, as well as for patients who have not observed increased tear secretion despite the use of topical anti-inflammatory drugs or punctal occlusion. This product is a complex emulsion ophthalmic medication, composed of multiple components including an aqueous phase and an oil phase, making its formulation and manufacturing ...
On March 18, Novartis announced that secukinumab has received FDA approval for a new indication in the United States for the treatment of moderate to severe hidradenitis suppurativa (HS) in children aged 12 years and older . Screenshot source: Official WeChat account of the company Secukinumab is the world’s first approved fully human interleukin (IL)-17A inhibitor that can specifically neutralize IL-17A from multiple sources and inhibit its pro-inflammatory effects. On December 26, 2014, the drug was first approved globally in Japan, and subsequently approved for marketing in the European Union and the United States in January 2015. It entered the Chinese market for the first time in 2019. Currently, the drug has been approved globally for multiple indications, including hidradenitis suppurativa, juvenile idiopathic arthritis, psoriasis, and psoriatic arthritis. This approval for secukinumab in patients aged 12 years and older with moderate to severe hepatitis B (HS) weighing over 30 kg ...
[Beijing, China – March 18, 2026] Huahui Anjian announced that its independently developed, world’s first-in-class ribevittamab injection (trade name: Huayounuo), targeting PreS1 of hepatitis B and hepatitis D viruses, was successfully prescribed globally on March 16 at Beijing Friendship Hospital affiliated with Capital Medical University. This marks the official entry of my country’s first hepatitis D treatment drug into the clinical application stage. As a domestically developed original drug with independent innovation throughout the entire process from “target mechanism” to “drug creation,” ribevittamab will provide a more effective and accessible treatment option for patients with chronic hepatitis D virus (HDV) infection in my country and more countries along the “Belt and Road” initiative. picture Ribevirtamaab received conditional approval from the National Medical Products Administration (NMPA) on January 20, 2026, for the treatment of adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis. This product is ...
On March 19, 2026, Novartis announced that its innovative biologic, Zorla® ( omalizumab), a pre-filled auto-injector pen, has been approved by the National Medical Products Administration for the treatment of adults and adolescents (12 years and older) with chronic spontaneous urticaria (CSU) and patients diagnosed with IgE (immunoglobulin E)-mediated asthma who still have symptoms after treatment with H1 antihistamines. (This product is indicated for adults and adolescents (12 years and older) with moderate to severe persistent allergic asthma whose symptoms are not effectively controlled after treatment with inhaled corticosteroids and long-acting inhaled β2 – adrenergic receptor agonists.) According to reports, Zorula has been on the global market for over 20 years, with multiple dosage forms and indications, and is widely used in more than 90 countries and regions, including China. https://www.vbdata.cn/1519067858
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