On March 16, 2026, Structure Therapeutics announced that Alenigliffon, which is used to treat patients with obesity/overweight and at least one weight related complication, has achieved positive top line data in the ACCESS clinical program.
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The data includes 44 week data from the Phase II ACCESS I1 study, mid-term data from ongoing body composition studies, and mid-term data from the ACCESS Open Label Extension (OLE) study. Aleniglipron (GSBR-1290) is an investigational oral small molecule glucagon like peptide-1 (GLP-1) receptor agonist. GLP-1 receptor is a mature drug target for obesity and type 2 diabetes (T2DM). Based on the structure based drug discovery platform of Structure Therapeutics, aleniglipron is designed as a biased G protein coupled receptor (GPCR) agonist that can selectively activate the G protein signaling pathway.
Rhythm's first MC4R weight loss drug phase III clinical failure
On March 16, 2026, Rhythm Pharmaceuticals released the main data of its Phase 3 global clinical trial EMANATE for its anti drug drugs. This experiment evaluated the efficacy of setmelanotide in four rare subgroups of inherited obesity. The results showed that all sub studies did not meet the predetermined primary endpoint.
Setmelanotide is a pioneering MC4R (melanocortin 4 receptor) agonist that targets the repair of the damaged MC4R pathway in the hypothalamus, regulates appetite and energy balance, and directly acts on the fundamental mechanism of genetic obesity.
The drug (trade name IMCIVREE @) has been approved by the US FDA for the treatment of rare obesity caused by specific genetic defects, such as Bardet Biedl syndrome and genetic obesity caused by POMC, PCSK1, LEPR, etc. It is suitable for children and adults aged 2 years and above.
To further validate the clinical efficacy of Setmelanotide, its global multicenter EMANATE study has been officially launched. This study adopts a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Setmelanotide in rare obese patients with MC4R pathway gene mutations.
Bo Wang Pharmaceutical's siRNA therapy BW-20805 has been granted fast track qualification by the FDA for the treatment of hereditary angioedema (HAE)
On March 16, 2026, Borgward Pharmaceuticals Co., Ltd. (referred to as Borgward Pharmaceuticals), a clinical stage biotechnology company, announced that its siRNA therapy BW-20805 has been granted Fast Track Design (FTD) by the US Food and Drug Administration (FDA) for the treatment of hereditary angioedema (HAE). BW-20805 is an siRNA therapy targeting prekalikrein (PKK), which inhibits PKK expression by targeting PKK mRNA and is expected to provide long-lasting seizure prevention for HAE patients. PKK is a recently validated target in the field of HAE therapy. Qianwang Pharmaceutical is currently conducting Phase I clinical trials in adult HAE patients, and is expected to complete the Phase I clinical trials in the second half of 2026 and subsequently initiate Phase I clinical trials.
GSK's first new hepatitis B drug is proposed to be included in the priority review, which is expected to achieve functional cure
On March 17, 2026, CDE official website showed that GSK's new chronic hepatitis B drug Bepirovirsen injection was proposed to be included in the priority review for the limited course treatment of patients with chronic hepatitis B virus infection, which was applicable to the following populations: nucleoside (acid) analogues under treatment HBsAg≤3000U/mlL, Adult chronic hepatitis B virus infected individuals without cirrhosis. GSK previously said in a press release that the drug is expected to become the first drug to achieve functional cure of chronic hepatitis B.
Beproveisen is an antisense oligonucleotide (ASO) therapy introduced by GSK from Ionis, aimed at inhibiting the replication of hepatitis B virus DNA, thereby suppressing the level of hepatitis B surface antigen (HBsAg) in the blood and stimulating the immune system to produce a persistent response. This drug is the first small nucleic acid drug in the field of chronic hepatitis B that has completed Phase II research.
Two registered phase II clinical trials (B-Well1 and B-Wel 2) evaluated the functional cure efficacy, safety, pharmacokinetic characteristics, and efficacy persistence of bevacizumab compared to placebo in patients with chronic hepatitis B who had previously received nucleoside (acid) analog therapy and baseline HBsAg ≤ 3000IU/ml. The primary endpoint of the study is the functional cure rate of patients with baseline HBsAg ≤ 3000IU/ml, and the key secondary endpoint is the functional cure rate of patients with baseline HBsAg ≤ 1000IU/ml.
Frontier biological siRNA new drug approved for clinical use, targeting IgA nephropathy
On March 16, 2026, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that FB7013 Injection, a Class 1 new drug of Frontier Biotech, has been approved for clinical use in the treatment of primary 1gA nephropathy.
According to public information, FB7013 injection is a GaINAc conjugated siRNA drug targeting MASP-2, and inhibiting MASP-2 may have a protective effect on both the glomerulus and tubulointerstitial of lgA nephropathy. L9A nephropathy is one of the common primary glomerular nephropathy, characterized by abnormal deposition of immune complexes of immunoglobulin A (19A, mainly lactose deficient 19A1, Gd-1gA1) in the mesangial area of the glomerulus, leading to pathological changes such as mesangial cell proliferation and matrix expansion, ultimately resulting in chronic renal failure/end-stage renal disease (ESRD).
FB7013 injection is an siRNA drug that targets the key protein MASP-2 in the complement system lectin pathway. This product specifically inhibits MASP-2 activity and blocks abnormal activation of the lectin pathway, reducing complement mediated kidney tissue damage; Based on the mechanism of action, it can be extended to membrane nephropathy, diabetes nephropathy and other diseases related to abnormal complement activation in the future.