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February 24, 2025
eMedClub News
Recently,A重磅消息 has rekindled the hope of patients with chronic hepatitis B ——GSK announced in its 2024 financial reportWorld's First Functional Cure for Hepatitis B Antisense Oligonucleotide Candidate Drug——GSK3228836 (Bepirovirsen) is expected to be launched next year. This transformative therapy has the potential to end the plight of chronic hepatitis B patients requiring lifelong medication.Clinical trial data shows that，BepirovirsenShowed significant efficacy in patients with chronic hepatitis B. In the early 2b phase clinical trial, after 24 weeks of treatment, nearly one-third of the patients achievedKey Marker of Hepatitis B Virus in the Body [Hepatitis B Surface Antigen (HBSA)g) and the disappearance of hepatitis B virus DNA, which means that the damage of the virus to the liver will be greatly reduced. Moreover, 24 weeks after discontinuation of the drug, about 10% of patients can still maintain this clearance effect.And there are no significant side effects,This indicates that the therapy does not "temporarily suppress" the virus, but rather has the potential to achieve long-term stable therapeutic effects.The Dilemma and Glimmer of Hope in Hepatitis B TreatmentAs a major country with hepatitis B, one out of every three hepatitis B patients globally is in China.According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)", there are approximately 86 million people in China infected with chronic hepatitis B virus, with about 20 to 30 million cases of chronic hepatitis B.Including mother-to-child transmission, blood transmission, and sexual transmission, among other routes, the scope of hepatitis B transmission continues to expand.
However, at this stage, clinically used for hepatitis B treatmentNucleos(t)ide analogues and interferons, onlyCanInhibiting viral replication without complete eradication of the virusCovalently closed circular DNA (cccDNA) is the template for hepatitis B virus replication. ItIt exists in the form of mini-chromosomes within hepatocyte nuclei and is extremely stable. Once treatment is discontinued, cccDNA can restart viral replication, leading to recurrence of the disease. Therefore, patients often require long-term or even lifelong medication.
At this time,The emergence of small nucleic acid drugs has brought new hope for the functional cure of hepatitis B.. Small nucleic acid drugs mainly includeAntisense oligonucleotide (ASO）, small interfering RNA (siRNA), etc.,Highly targeted compared to traditional drugs。They can bind to the mRNA of the hepatitis B virus or other key RNA sequences through the principle of base complementary pairing. Taking ASO drugs as an example, after binding to the target RNA, they recruit nucleases to degrade the target RNA, thereby blocking the synthesis of hepatitis B virus proteins and inhibiting viral replication and spread.
At the same time,Small nucleic acid drugs can also affect the transcription process of cccDNA.，Let cccDNA remain in a "silent" state, thereby achieving functional cure of hepatitis B, that is, in the patient's bloodHBSAgDisappear, undetectable HBV DNA, liver function returns to normal, liver inflammation is alleviated, significantly reducing the risk of complications such as cirrhosis and liver cancer.
Small Nucleic Acid Enterprises in China: A Hundred Boats Racing, Bravely Striving for the LeadBepirovirsenThe progress of the listing process has once again made the small nucleic acid drug field a focal point. In recent years, advancements in chemical modification and delivery technologies have...Breakthrough: Significant Progress Achieved in the Development of Small Nucleic Acid Drugs Produced in China。MedCareer Insight captures industry trends and carefully reviewsNearly a hundred small nucleic acid enterprises in China. These companies each have their own strengths in technological innovation, product development, and market expansion.Take you to the front-line dynamics of the industry (personally organized, if there are omissions, please feel free to add).
▲Review of Small Nucleic Acid Enterprises in China (CXO Companies Not Included in This Table)In China, small nucleic acid enterprises have also made significant progress in the field of hepatitis B treatment.20February 2025,Haobo MedicineHepatitis B in ResearchASOThe candidate drug — AHB-137 — has also completed dosing in the Phase 2b clinical trial and officially entered the unblinding phase.November 2024,Starry KunzeaPhase 1b clinical trial data of the investigational hepatitis B siRNA candidate drug, HT-101 injection, showed that all subjects in the HT-101 dosing group who participated in the extension period follow-up maintained a good reduction in HBsAg at 48 weeks.August 2024，RiboBioRBD1016 Injection – A Promising siRNA Candidate for Hepatitis BThe Phase 2 clinical trial was approved by the CDE. Previously, the Phase 1 clinical data also showed good safety and tolerability, with high efficiency in reducing HBsAg in hepatitis B patients, and the efficacy can last nearly half a year.In May 2024,Brii BiosciencesThe siRNA candidate drug for hepatitis B under research —— BRII-835 (Elebsiran) has beenCDEIncluded in the breakthrough therapy category, the drug demonstrated good tolerability and significant HBsAg reduction effects in Phase 2 clinical trials.In addition to the field of hepatitis B treatment, small nucleic acid enterprises in China have also laid out in several other disease areas.RiboBioAs one of the earliest established small nucleic acid enterprises, it has built a rich product pipeline around cardiovascular metabolic diseases, liver diseases, kidney diseases, and rare diseases.SirnaomicsIt focuses relatively on the oncology field while developing peptide nanoparticle delivery systems, with pipelines covering various diseases such as fibrosis and metabolic disorders.2025 IBI EXPO Biopharmaceutical Innovation Industry ConferenceComing soon,In order to help everyone accurately grasp the industry trends!MedCareer delves into the 2024 nucleic acid drug track, covering the latest clinical progress both in China and internationally, major financing deals that are causing ripples in the industry, and favorable new policies that provide a safeguard for industry development. All these are comprehensively captured in their latest release."Leading 2025" Annual Review and Outlook of mRNA and Small Nucleic Acid Drugs, click on the image below to view detailed content and claim it for free~
Below,We will introduce several representative companies that have made the latest progress in 2025.In February 2025, the preclinical data of RBD4059, an anti-coagulation/anti-thrombotic GalNAc-conjugated siRNA candidate drug independently developed by Ribo Biotech, was published in an authoritative cardiovascular journal.The results of the existing Phase 1 clinical trial show that RBD4059 demonstrates sustained FXI activity and protein reduction effects, while also showing good safety. This candidate drug is currently undergoing Phase 2 clinical trials in Europe.In January 2025, Ribo Bio announced the achievement of the first milestone in its collaboration with Boehringer Ingelheim, which began inA year ago, to jointly develop small nucleic acid innovative therapies for the treatment of non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH),Total transaction amount exceeds 2 billion US dollars。▲ Ribo Biotech's R&D PipelineThe technical core of Ribo Biotech isRIBO-GalSTAR™——GalNAc Ligand Liver-Targeted Delivery Technology, RIBO-OncoSTAR™——Tumor-targeted delivery technology andRSC2.0Second-generation modification technology.The company has now entered the rapid development phase for small nucleic acid drug varieties, with 8 clinical varieties, 5 of which are based onLiver-targeted delivery technology。February 2025,HaoBo Pharmaceuticals Announces CompletionCompleted the dosing of all patients in the Phase 2b clinical study of its non-conjugated ASO candidate drug, AHB-137, intended for the treatment of chronic hepatitis B. The candidate drug performed well in the preliminary results of the previously announced Phase 2a study, with serum HBsAg levels rapidly decreasing after treatment in all subjects following at least 12 weeks of treatment. In 2024, Haobo Medicine completed a $73 million Series B financing round in December and a $37 million Series A financing round in July.▲Med-Oligo™ Technology PlatformHaobo MedicineThe core technology isMed-Oligo™—Multi-segment Enhanced and Dual-Action Small Nucleic AcidsThe platform, through innovative chemical modifications with forward-looking properties, has achieved higher efficacy and safety while modulating immune function. At the same timeMed-Oligo™ASO molecules can bind to a variety of ligands, achieving targeted delivery to different tissues and organs.In January 2025, ViaGen announced itsLiver-targeted APOC3The marketing authorization application for the siRNA candidate drug — VSA001 Injection (Pulesiran Sodium) has been officially accepted by the NMPA for the treatment of Familial Chylomicronemia Syndrome (FCS).In December 2024, the drug is proposed to be included in the NMPA's priority review and is also in the application phase for market approval in the United States.Viya Zhen refers to this as the world's first drug targeting the APOC3 site to be submitted for marketing approval.
In addition, Viya Zhen has 3 siRNA candidate drugs that have entered the clinical stage:VSA012（Targeting CFB in the Liver）、VSA003 (TargetedANGPTL3 in Hepatocytes) and VSA006 (Targeting HSD17β13 in Hepatocytes). In January 2025, the first healthy subject was dosed with VSA012 to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. In December 2024,VSA003The first patient dosing in the Phase 3 clinical trial has been completed, aiming to evaluate the efficacy and safety of VSA003 injection in Chinese adolescents and adults with homozygous familial hypercholesterolemia. In April 2024, VSA006 completed the first patient dosing in the Phase 2 clinical trial, aiming to evaluate the efficacy and safety of VSA006 in Chinese adult patients with non-alcoholic steatohepatitis (NASH).From the promising listing of GSK's ASO candidate drug to the vigorous efforts of multiple small nucleic acid enterprises in China on their R&D paths, we are witnessing profound transformations in the field of hepatitis B treatment driven by the development of small nucleic acid drugs. At the start of the new year, within less than two months, small nucleic acid enterprises in China have continued to make significant progress, actively...AdvanceClinical,Filing for marketing approval and laying out multiple pipelines demonstrates their respective innovative vitality and R&D strength.However, we must soberly recognize that there are still many challenges for small nucleic acid drugs to move from the laboratory to widespread clinical application. At the technical level, how to further optimize nucleic acid design, improve drug stability and targeting, and reduce off-target effects remain difficult problems that need continuous resolution. In terms of clinical trials, strict trial requirements and lengthy cycles demand that companies possess strong financial capabilities and patience. Market competition is also becoming increasingly fierce; domestic companies not only need to stand out in the local market but also compete with multinational pharmaceutical enterprises on the international stage.In the future, with the continuous advancement of technology and the relentless efforts of companies, it is believed that small nucleic acid drugs will play an even greater role in the treatment of hepatitis B and other diseases. We look forward to China's small nucleic acid enterprises standing out in the global wave of pharmaceutical R&D, bringing good news to more patients, driving China's biopharmaceutical industry to new heights, and writing an innovative chapter for China on the international stage.1.Official websites of various companies and public information2.https://mp.weixin.qq.com/s/xYb55IRTYjqpcMJ1XhAQgwWelcome everyone to register for the 2025 IBI EXPO conference and move forward with the times. Below is the 2024 IBI EXPO.Video Highlights of the Event.Registration and Event Inquiry
IBI EXPO 2025 (3rd) Biologics Innovation ConferenceWill beMarch 1, 2025 to March 2, 2025InSuzhou International Expo CenterGrandly held. The theme of the conference isCollaboratively Build the Entire Chain, Innovate and Transform the New Ecosystem。
The conference will invite300+Guest Speaker, Opening30+Forum events, covering hundreds of hot topics, aroundCell and Gene Therapy, Radiopharmaceuticals, Antibody Innovation Conjugation, Targeted Protein Degradation, Stem Cell Regeneration, mRNA Vaccines and Nucleic Acid Drugs, Exosomesetc.New Molecular Drugs,AI Drug Discovery, Organoids, Novel Delivery Vectorsetc.Cutting-edge Technology，Engage in exchange and discussion, and collaboratePharmaceutical companies, research institutions, clinical resources, supply chain enterprises, investment and financing institutions, park governmentsWith the efforts of multiple parties, cutting-edge innovations are being transformed from scientific research to industrial applications, injecting developmental momentum into the biopharmaceutical market.Free Participation:Teacher Yang 15517201185Free Exhibition:Teacher Yuan 15572286596Speech & Media:Teacher Wang 18717836231Click"Read the original text"Lock in Early Bird DiscountsStatement and Copyright Notice
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