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Apr 24, 2026 Leave a message

On March 18, 2026, Zhongxin Biotechnology announced that the US Food and Drug Administration (FDA) has approved its clinical trial (IND) application for its mRNA candidate drug IN026. INO26 is an under development mRNA therapy for refractory gout. After the IND approval, the company will systematically evaluate the safety, tolerability, pharmacokinetics, and pharmacological characteristics of IN026 in a patient population with unmet treatment needs in Phase 1 clinical trials.

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INO26 achieves systemic degradation of uric acid in vivo by delivering mRNA encoding uric acid oxidase (UOX) to the liver. INO26 is an under development mRNA therapy aimed at treating refractory gout. It delivers mRNA encoding uric acid oxidase (UOX) to the liver and utilizes the expressed UOX to promote systemic degradation of uric acid in the body. Relying on the mRNA LNP (messenger ribonucleic acid lipid nanoparticle) technology platform independently developed by Zhongxin Biotechnology and designed for repeated administration and long-term disease control, INO26 is expected to become a potential first in class mRNA protein replacement therapy for refractory gout and other chronic metabolic diseases.

 

Johnson&Johnson's global first oral IL-23R targeted peptide Icotrokinra approved for market by FDA

On March 18, 2026, Johnson&Johnson announced that lcotrokinra (trade name: Icotyde) has been approved by the FDA for the treatment of moderate to severe plaque psoriasis (PsO) in adolescents and adults aged 12 years and older. icotrokinra is an oral peptide drug that can target the blockade of the iL23 receptor (IL-23R), with a single digit pM level binding affinity to IL-23R in children. This receptor is a key mechanism in the inflammatory response of plaque psoriasis and has potential applications in other IL-23-mediated diseases.

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Original research on IcotrokinraProtagonist Therapeutics. In 2017, Johnson&Johnson reached a licensing and collaboration agreement with Protagonist Therapeutics to develop a first generation IL-23R drug. The two parties expanded their cooperation scope in 2019 to include the second-generation IL-23R drug, with a total transaction amount of up to 1.025 billion US dollars. In 2021, Johnson&Johnson revised its cooperation agreement again and obtained global rights to two second-generation Er-23R drugs (Icotrokinra and JNJ-5186), with a maximum transaction value of up to 980 million US dollars.

 

Baiyang Pharmaceutical strategically invests in Sihe Gene and strengthens its AS0 small nucleic acid innovation layout

 

On March 19, 2026, Baiyang Pharmaceutical (301015. SZ) announced that the company plans to sign an "Investment Agreement" with Sihegen (Beijing) Biotechnology Co., Ltd. (hereinafter referred to as "Sihegen"), agreeing to invest 27 million yuan in cash in Sihegen. After the investment, the company will hold 10% equity of Sihegen. Through this cooperation, Baiyang Pharmaceutical strategically locks in the global first refusal and commercialization rights of all research pipelines of Sihegen.

Anti sense oligonucleotides (ASO) and small interfering RNA (siRNA) are currently the two mainstream technological pathways for small nucleic acid drugs, both of which regulate gene expression by targeting mRNA, achieving precise treatment of diseases. The Sihe Gene invested by Baiyang Pharmaceutical this time is a representative enterprise in China that focuses on the research and development of new generation ASO drugs. It has built the first ASO research and development platform in China with complete original capabilities, forming a unique competitive advantage compared to the siRNA route, and striving to promote the source innovation and clinical translation of domestic ASO drugs.

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Based on the first AI algorithm platform, innovative chemical modification platform, and fertilizer delivery platform designed efficiently for ASO sequences in China, Sihe Gene has formed a core technology matrix that drives innovative research and development. Recently, its independently developed Class 1 ASO new drug "SG12 Injection" for the treatment of chronic hepatitis B has been approved for IND clinical trials due to its excellent virus clearance ability and long-lasting inhibitory effect demonstrated in animal experimental models. At the same time, its innovative nucleic acid drug "SG13 product" for treating chronic heart failure has been successfully selected for the National Science and Technology Major Special Project for Innovative Drug Research and Development during the 15th Five Year Plan period. It is currently in the preclinical research stage and plans to apply for clinical trials in 2027.

 

NovoNordisk Smeaglutide 7.2mg approved for market launch

On March 19, 2026, Novo Nordisk announced that the high-dose version of Wegovy HD, 7.2mg of semaglutide, has been approved by the FDA for long-term weight control in combination with a low calorie diet and increased exercise.

The FDA has awarded Wegowy HD a Director level National Priority Review Certificate, accelerating the product's review process and highlighting its significant potential in meeting critical patient needs and national health strategies in the United States.
This accelerated approval is based on data from the STEPUP clinical trial project. In the STEPUP study, administering 7.2mg of semaglutide injection once a week resulted in an average weight loss of 20.7% in obese subjects, with approximately one-third of the subjects experiencing a weight loss of 25% or more. In Hejing Research on Obese People with Type 2 diabetes (STEP UP T2D), 7.2mg smeglutide achieved an average weight loss of 14.1%.

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Both trials once again confirmed the known safety and tolerability characteristics of semaglutide, and the overall performance at a dose of 7.2mg was consistent with previous clinical trials related to semaglutide weight management. Novo Nordisk expects the Wegovy HD single dose pen to be launched in the United States in April 2026.

Wegowy's once daily oral tablets (Megvii 25mg) and once weekly injections (Smeaglutide 1.7mg, 2.4mg, and 7.2mg) have been approved for marketing by the US FDA. Wegow's weekly injection has been approved by the European Medicines Agency (EMA) and multiple regulatory agencies worldwide. Wegowy oral tablets are currently awaiting market approval from EMA and other regulatory agencies.

Wegovy is suitable for obese or overweight adult patients to reduce excess weight and achieve long-term weight loss effects. Patients must also have at least one weight related complication. This product has also been approved by the FDA for use in obese or overweight adult patients with defined cardiovascular disease, reducing their risk of major adverse cardiovascular events, including death, myocardial infarction, or stroke. In addition, Wegow injection is suitable for adolescents aged 12 and above who are foolish, and is used to reduce excess weight and maintain long-term weight loss effects. This product has also been approved by the DA for the treatment of adult metabolic dysfunction associated steatohepatitis (MASH) with moderate to severe liver fibrosis (liver scar formation), but is not suitable for patients with cirrhosis.

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