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Sangfor Biotech announced that IN026 has received FDA approval for clinical trials, opening up a new direction for mRNA therapy in the field of chronic metabolic diseases.

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 ...
- Source: drugdu
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- March 23, 2026
【EXPERT Q&A】How to apply for a medical device production license?

Drugdu.com expert’s response: I. Application Requirements 1. Basic Requirements Possess production facilities, environmental conditions, manufacturing equipment, and qualified technical personnel suitable for the medical devices to be produced. Establish a quality inspection department staffed with full-time inspectors and equipped with necessary testing instruments. Develop and implement a quality management system covering production, quality control, and technical documentation to ensure medical device quality. Demonstrate after-sales service capabilities appropriate for the medical devices produced. 2. Personnel Requirements Production, quality, and technical managers must possess professional expertise relevant to the medical devices produced and be familiar with applicable regulations and technical standards. The quality manager shall not concurrently serve as the production manager. The proportion of technical personnel with junior professional titles (or above) or secondary vocational education (or higher) within the enterprise must meet product-specific requirements. For Class III medical device manufacturers, at least two internal auditors compliant with quality management system ...
- Source: drugdu
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- March 23, 2026
Baiyang Pharmaceuticals makes a strategic investment in Sihe Gene, further strengthening its ASO (App Store Optimization) small nucleic acid innovation strategy.

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 ...
- Source: drugdu
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- March 20, 2026
Multi-resistance pipeline outbreak

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 ...
- Source: drugdu
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- March 20, 2026
Qilu Pharmaceutical’s first ophthalmic preparation, cyclosporine ophthalmic emulsion, was exported to the United States.

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 ...
- Source: drugdu
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- March 20, 2026
Novartis’ secukinumab, used to treat hidradenitis suppurativa, has been approved for a new indication

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 ...
- Source: drugdu
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- March 20, 2026
The world’s first prescription for ribevirtadalab (Huayounuo®) has been officially issued

[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 ...
- Source: drugdu
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- March 20, 2026
Novartis’ innovative biologic omalizumab pre-filled auto-injection pen has been approved in the country.

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
- Source: drugdu
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- March 20, 2026
Xuanjing Biotech Completes Over 200 Million Yuan Pre-A Round Financing

On March 20, Rigerna Therapeutics (Suzhou Xuanjing Biotechnology Co., Ltd.) announced the completion of a Pre‑A financing round totaling over 200 million yuan, led by Kangjun Capital. Participating investors include Delian Capital, Huatai‑GenScript Fund, Jinyi Fuxin, Guohai Innovation Capital, Lenovo Capital, and existing shareholder Yuanxi Haihe Fund, Xuanjing Biological. Founded in 2022, Rigerna Therapeutics is innovation‑driven and focuses on nephrology and metabolic diseases, aiming to become a leader and innovator in the small nucleic acid (oligonucleotide) pharmaceutical field Xuanjing Biological. With forward‑looking strategic planning, its lead pipeline has entered Phase II clinical trials and is poised to become the world’s first approved small nucleic acid drug for IgA nephropathy. Addressing unmet clinical needs in renal and metabolic disorders, Rigerna is developing multiple First‑in‑class programs, building a multi‑layered, gradient pipeline matrix. The completion of this financing round and advancement of several BD collaborations have secured substantial cash reserves, laying a solid ...
- Source: drugdu
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- March 20, 2026
Chia Tai Tianqing’s First Class 1 New Drug TQB6457 Approved for Clinical Trials, World’s First CCR8+PD-1 Fixed-Dose Combination

Recently, TQB6457 Injection, a Class 1 innovative drug developed by Chia Tai Tianqing Pharmaceutical Group, a core subsidiary of China Biologic Products Holdings, Inc. (1177.HK), has been granted clinical trial implied approval by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of advanced malignant tumors. As the world’s first fixed-dose combination of a CCR8 monoclonal antibody and a PD‑1 antibody to enter clinical research, this product is designed to replace combination therapy with a single agent, helping to improve medication adherence among patients with advanced tumors and overcome treatment limitations. CCR8 is a promising target specifically and highly expressed on the surface of regulatory T cells (Tregs) in the tumor microenvironment, and plays a key role in recruiting Tregs to tumor sites. PD‑1 is a canonical immune checkpoint protein; tumor cells can trigger immunosuppression by binding PD‑1 via PD‑L1. As a dual-targeted ...
- Source: drugdu
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- March 20, 2026

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