TIDES Weekly Digest | Global Peptide and Oligonucleotide Therapeutics Highlights (June 6–12, 2025)
NeoCura
RNA Innovative Drug Developer
Recently，The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially approved NeoCura's self-developed mRNA personalized tumor neoantigen vaccine XH001 to commence clinical research.
XH001 is the first personalized tumor neoantigen vaccine developed by NeoCura based on its AI-driven mRNA technology platform. By utilizing the self-developed and proprietary NeoCura AI ALPINE system to screen for highly immunogenic neoantigens, the vaccine integrates the unique mutation profile of a patient’s tumor cells with HLA typing data to customize corresponding encoded personalized treatments.Neoantigen Vaccine: Activating Tumor-Specific T Cells, Precisely Eliminating Residual Tumor Cells, and Reducing Recurrence Risk at the Source.
About NeoCura
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NeoCura is a high-tech enterprise that relies on AI technology to focus on the research and development of innovative RNA drugs. It has built a multi-omics big data collection platform and a multi-dimensional biomics database, using AI and bioinformatics technology for in-depth drug target mining and fully automated drug design for innovative RNA drug research. It has established a leading RNA drug production center in China to support pipeline research and development and clinical needs.
June 5, 2025DayAccording to the ClinicalTrials.gov official website, Novartis has registered a Phase I clinical study of [225Ac]Ac-ETN029 for the treatment of patients with advanced DLL3-expressing solid tumors (Registration Number:NCT07006727）。
This is a Phase I open-label, multi-center study designed to evaluate[225Ac]Ac-ETN029InSafety in Patients with Advanced Solid Tumors Expressing DLL3Sex, tolerance, dosage, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy, as well as the safety, dosage, pharmacokinetics, and imaging characteristics of 111In-ETN029.
About Novartis
Novartis is committed to reimagining medicine to improve people's quality of life and extend human lifespan. By leveraging our technological leadership in research and development along with innovative accessibility initiatives, we deliver high-value medicines that alleviate the greatest disease burdens on society.
June 6, 2025DayShanghai Minwei Biotechnology Co., Ltd. registered the Phase I clinical trial of MWN109 tablets on the Drug Clinical Trial Registration and Information Disclosure Platform website. This is the world's first oral GLP-1/GIP/GCG triple agonist new drug.
The Phase I clinical SAD enrolled overweight or obese patients with a BMI between 24 and 37.5.
This Phase I clinical trial is being conducted at the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, with a planned enrollment of 108 subjects.
About MWN109 Tablets
MWN109 Tablets, developed by Shanghai Minwei Biotechnology Co., Ltd., are a fatty acid chain-modified peptide with GLP-1/GIP/GCG activity and possess global intellectual property rights. MWN109 Tablets are an oral formulation developed based on MWN109 Injection, with a mechanism of action that stimulates insulin secretion from pancreatic β-cells to effectively control blood glucose levels. It also increases satiety by delaying gastric emptying and reducing gastric acid secretion, thereby decreasing energy intake. Additionally, it promotes fat breakdown, enhances energy expenditure, and boosts basal metabolism, effectively reducing body weight.
About Shanghai Minwei Biotechnology Co., Ltd.
Shanghai Minwei Biotechnology Co., Ltd. was established in 2021 and is now controlled by Lepu (Beijing) Medical Device Co., Ltd. It is an innovative biotechnology company focusing on metabolic and cardiovascular disease fields.
June 6, 2025Day，Center for Drug Evaluation, National Medical Products Administration (CDE）Official website announcement,Circular RNA of Yuan BioRNADrugTI-0093Clinical Trial of Injection (IND) Application Accepted (Acceptance No.:CXSL2500461）。TI-0093Injectable solution is clinically intended for treatmentHPV16Positive advanced recurrent or metastatic solid tumors.
About Human Papillomavirus
Human Papillomavirus (HPV) is a common non-enveloped double-strandedDNAVirus, belonging to the Papillomaviridae family and the Papillomavirus genus, persistent high-risk type (16、18、31、33etc.)HPVInfection is a leading cause of various cancers, including cervical cancer, head and neck cancer, anal cancer, etc. Among themHPV16InHPVThe proportions of positive head and neck cancer and cervical cancer are respectively91.2%And52.9%. To date, there are no specific targetedHPV16Drug for Positive Malignant Tumor Approved for Marketing Application.
About TI-0093Injection
TI-0093Injection (abbreviationTI-0093) is a therapeutic vaccine developed by Yuanjin (Beijing) Biotechnology Co., Ltd. using circular RNA (CircRNA) technology. It belongs to the category of therapeutic biological products and is clinically intended for the treatment of HPV16-positive advanced recurrent or metastatic solid tumors.
AboutCircleBio
Circle Biotechnology focuses on circularRNAResearch and application of technology in the field of innovative drugs and therapies, committed to building an internationally competitive innovative drug R&D platform.
June 7, 2025Day, the CDE official website shows that Eli Lilly'sGLP-1R/GIPR Dual AgonistThe new indication application for Tirzepatide has been accepted, and it is speculated that the indication applied for this time isObstructive Sleep Apnea.
Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder characterized by the complete or partial collapse of the upper airway during sleep, leading to apnea or hypopnea, and potentially causing reduced blood oxygen saturation and/or arousals from sleep. Obstructive sleep apnea can result in severe cardiometabolic complications, including hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation, and type 2 diabetes.
December 2024,Tirzepatide Receives FDA Approval as the First and Only Treatment forA prescription drug for adult patients with moderate to severe OSA and obesity. While using tirzepatide, a reduced-calorie diet and increased physical exercise should be implemented.
About Tirzepatide
Tirzepatide is a novel therapeutic drug for diabetes, acting as a dual agonist of the GLP-1 receptor and GIP receptor. Administered once weekly, it effectively improves blood glucose control in patients with type 2 diabetes. Tirzepatide increases insulin secretion by activating the GIP receptor, helping the body utilize and store glucose more efficiently, thereby lowering blood sugar levels. Additionally, by activating the GLP-1 receptor, it enhances satiety, reduces appetite, assists patients in controlling their diet, and achieves weight loss effects. Tirzepatide has been approved in China for the treatment of obesity and type 2 diabetes.
About Eli Lilly and Company
Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, production, and sales of medicines, committed to improving human health through innovation.
June 9, 2025DayYinuo Pharmaceutical's Hong Kong IPO application has been accepted, with CITIC Securities and CICC as the sponsors.
Silver诺Pharmaceuticals was founded in 2014. Over the past 11 years, it has established a rich pipeline of metabolic R&D, with its core product being the GLP-1 new drug Ersupagludec, which was approved for marketing in January 2025 to treat type 2 diabetes.
The latest equity structure of Silver诺 Pharma is as follows: Dr. Wang Qinghua, the actual controller, and his concert parties hold36.07% held by Gu, 9.94% by KIP, 6.32% by Cowin, 6.03% by Lan Ting Investment, 5.38% by Guangzhou Industrial Investment, and 4.15% by Tongchuang Venture.
About Yinnuo Pharmaceuticals
Yinuo Pharmaceuticals, founded in 2014, is a science-driven biotechnology company dedicated to providing innovative, accessible, and affordable high-quality medicines for patients with metabolic diseases.
June 9, 2025DayLivzon Pharmaceutical (SZSE: 000513; HKEX: 01513) announced that the clinical trial application (IND) for its Class 1 innovative drug YJH-012 has been officially accepted by the National Medical Products Administration (NMPA) recently. The drug, developed based on small interfering RNA (siRNA) technology, is a potential First-in-class small nucleic acid drug in the global gout treatment field, with the hope of providing patients with a more effective and safer long-acting treatment option for gout.
Gout is a common and complex type of arthritis caused by hyperuricemia. In recent years,The prevalence of hyperuricemia is increasing year by year, and the age of onset shows a significant trend of becoming younger. It has become the second largest metabolic disease, only after diabetes.
Livzon Pharmaceutical (with global rights) and Youjia Bio jointly developed a novel siRNA drug, YJH-012. Its Investigational New Drug application (IND) has been accepted by the National Medical Products Administration. Targeting gout with hyperuricemia, this drug differs from traditional medications that inhibit enzyme activity to block uric acid synthesis, as it achieves long-term suppression at the genetic level.A breakthrough in the mechanism of uric acid production is expected to provide a longer-lasting, safer, and more thorough solution for clinical use.
AboutLivzon Pharmaceutical Group Inc.
Livzon Pharmaceutical Group Inc. was founded in January 1985. It is a comprehensive pharmaceutical group company integrating the research and development, production, and sales of pharmaceutical products. The company regards R&D innovation as the cornerstone of sustainable development, continuously focusing on new molecules and cutting-edge technologies in the global new drug R&D field. Based on clinical value, it strategically plans for innovative drugs and high-barrier complex formulations with differentiation. The company focuses on areas such as gastroenterology, assisted reproduction, psychiatry, and tumor immunology, forming a complete product cluster and a differentiated product pipeline covering the entire R&D cycle.
June 9, 2025DayMerck announced that two Phase III studies (CORALreef HeFH and CORALreef AddOn) of the oral PCSK9 inhibitor Enlicitide (MK-0616) for the treatment of hypercholesterolemia have met their primary endpoints. This is the world's firstPhase III Study SuccessfulOral PCSK9 inhibitors.
MK-0616 is an oral cyclic peptide PCSK9 inhibitor developed by Merck. PCSK9(PCSK9, Proprotein Convertase Subtilisin/Kexin Type 9) is primarily expressed in the liver and acts as an accomplice in elevating "bad cholesterol" LDL-C. PCSK9 can bind to receptors on the surface of hepatocytes responsible for clearing LDL-C, causing most LDL-C to remain unabsorbed.
AboutMSD
At MSD (the corporate name of Merck & Co., Inc., Kenilworth, N.J., USA), we unite in a common mission: harnessing the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.
June 9, 2025Day，Metsera Positive Data from Phase I Clinical Trial of MET-233i Announced
MET-233i is an ultra-long-acting amylin analog designed to achieve best-in-class durability, efficacy, and the ability to be combined with Metsera's once-monthly, fully biased GLP-1 receptor agonist MET-097i.
The result announced this time is from a randomized, placebo-controlled, double-blind Phase I clinical trial, which aims to evaluate 80Pharmacokinetics, efficacy, and safety of subcutaneous injection of MET-233i in overweight or obese subjects (without type 2 diabetes). The average baseline body mass index (BMI) of the subjects was approximately 32.
About Metsera
Metsera is a clinical-stage biopharmaceutical company dedicated to the treatment of obesity and metabolic diseases. The company's innovative technology platforms, HALO™ and MOMENTUM™, optimize the half-life and oral delivery efficiency of peptide drugs, respectively, supporting multiple potential best-in-class and first-in-class drugs.
June 10, 2025Day，Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company") announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), has received notification from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") that the Investigational New Drug (IND) application for HDM1010 tablets submitted by Zhongmei Huadong has been approved by the U.S. FDA. A Phase I clinical trial can now be conducted in the United States for the indication of type 2 diabetes.
HDM1010 tablets are a fixed-dose combination formulation of HDM1002/SGLT2 inhibitors independently developed by Sinopharm Huadong. HDM1002 is an innovative small molecule drug independently developed by Sinopharm Huadong, which possesses global intellectual property rights. It is an orally active, potent, and highly selective full agonist of the GLP-1 receptor. HDM1002 can strongly activate the GLP-1 receptor, induce the production of cyclic adenosine monophosphate (cAMP), and has potent effects in improving glucose tolerance, lowering blood sugar, and reducing weight.Showed good safety.
About Huadong Medicine
Huadong Medicine Co., Ltd. was established in 1993 and listed on the Shenzhen Stock Exchange in December 1999. After more than 20 years of development, it has become a large comprehensive pharmaceutical listed company integrating pharmaceutical research and development, production, and distribution.
June 11, 2025Day，Boan Biotech Announces Strategic Cooperation Agreement with Shanghai Pharmaceutical Holdings Co., Ltd. (Shanghai Pharma), Granting the Latter Exclusive Rights for Full-Channel Terminal Promotion of Dulaglutide Injection (Product Code: BA5101) in Mainland ChinaNational General Agency Rights. BA5101 is Trulicity.®(English brand name: Trulicity®) Biosimilar, for adult Type 2 diabetesGlucose control for patients, currently under review for marketing application in China and approved for clinical trials in the United States.
Dulaglutide is a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist administered once weekly. Compared with other types of hypoglycemic agents, dulaglutide improves the function of pancreatic β-cells, providing stable and effective reduction of blood glucose and glycated hemoglobin (HbA1c) levels. Additionally, its unique mechanism of action is less likely to cause hypoglycemia, while also reducing body weight, lipid levels, and the long-term risk of cardiovascular diseases, offering protective effects on the kidneys.The once-weekly dosing of dulaglutide can also reduce the inconvenience for patients when taking medication, with low gastrointestinal side effects and good compliance.
About Boan Biologics
Boan Biotech (6955.HK) is a fully integrated biopharmaceutical company specializing in the development, production, and commercialization of biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic disorders.
June 10, 2025Day，Novartis in drugsClinical Trial and Information Disclosure Platform registered oneEvaluation of [177Lu]Lu-DOTA-TATE (Lutetium [177Lu]-Octreotide，Lutathera）In Stage 1 and Stage 2 advancedGastroenteropancreatic Neuroendocrine Tumors (GEP-NET)Phase III Study of Efficacy and Safety in Patients (NETTER-3).
NETTER-3 is a Phase III, international, multicenter, randomized, open-label study designed to evaluate [17 in patients newly diagnosed with somatostatin receptor-positive (SSTR+), well-differentiated Grade 1 and Grade 2 (G1 and G2) (Ki-67<10%) advanced GEP-NET with high tumor burden (examples of high tumor burden are provided in Section 5.1).7Lu]Lu-DOTA-TATE + Octreotide LAR versus Octreotide LAR Monotherapy: Efficacy and Safety.
About Novartis
Novartis is committed to reimagining medicine to improve people's quality of life and extend human lifespan. By leveraging our technological leadership in research and development, along with innovative accessibility initiatives, we deliver high-value medicines that alleviate the greatest disease burdens on society. In our pursuit of new drugs, we continuously innovate, maintaining a leading position in R&D investment within the global pharmaceutical industry. Novartis has approximately 106,000 employees from over 140 countries and regions worldwide, and nearly 800 million patients globally benefit from Novartis products.
June 10, 2025Day, a wholly-owned subsidiary of Philogen GroupPhilochem AnnouncesWith Bristol-Myers Squibb (BMS)Wholly-owned subsidiary RayzeBio has reached a final agreement to acquire OncoACP3 (a clinical-stage prostate cancer treatment and diagnostic drug).ExclusiveGlobalDevelopment, production, and commercialization rights are granted to the latter.The two parties expect the transaction to be completed in the third quarter of 2025.
According to the terms of the agreement, Philochem will receive an upfront payment of $350 million, as well as up to $1 billion in research and development, regulatory, and commercialization milestone payments. The company also has the opportunity to receive royalties in the mid-single-digit to low-double-digit range based on global net sales of OncoACP3.
OncoACP3 is a small-molecule ligand with high affinity and specificity for the novel prostate cancer target acidic phosphatase 3 (ACP3), which can be used to develop diagnostic and therapeutic radiopharmaceuticals. Philochem has developed four radiopharmaceuticals based on this ligand: 68Ga-OncoACP3 (diagnostic radiopharmaceutical), 177Lu-OncoACP3 (therapeutic radiopharmaceutical), 18F-OncoACP3 (diagnostic radiopharmaceutical), and 225Ac-OncoACP3 (therapeutic radiopharmaceutical).
June 11, 2025DayBowang Pharmaceutical Co., Ltd. (hereinafter referred to as "Bowang Pharmaceutical," or "the Company") announced that its self-developed Class 1 new drug, BW-20507, has received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B virus (HBV) infection. This designation is based on the drug’s significant antiviral activity and favorable safety profile demonstrated in early clinical trials, offering the potential for an improved treatment option for patients.
In May 2025, Bowang Pharmaceutical presented the latest research data on BW-20507 in a poster format at the Late-Breaker session of the European Association for the Study of the Liver (EASL). The study was conducted in Hong Kong, China, and Thailand. At the conference, the company showcased its remarkable efficacy in reducing hepatitis B surface antigen (HBsAg), achieving HBsAg clearance, and lowering hepatitis B virus DNA levels, drawing attention from experts both domestically and internationally. To date, no drug has demonstrated such significant therapeutic activity in clinical trials. The designation as a breakthrough therapy will further accelerate the clinical development process of this drug, promoting the early fulfillment of unmet treatment needs in the field of chronic hepatitis B both in China and globally.Demand.
About Bowang Pharmaceutical
Bowang Pharmaceutical is a clinical-stage biotechnology company dedicated to developing a new generation of RNAi therapies, providing better treatment options for patients worldwide.
June 12, 2025DayNovo Nordisk announced that based on current clinical data, following the EOP2 meeting with the FDA, it has decided to advance both subcutaneous and oral Amycretin into Phase III clinical trials for weight loss. Novo Nordisk plans to initiate the Phase III clinical trial for weight loss with Amycretin in the first quarter of 2026.
Amycretin is a long-acting GLP-1/Amylin dual receptor agonist.
In the Phase 1b/2a clinical trial, subcutaneous injection of 1mg, 5mg, and 20mg Amycretin for 36 weeks resulted in weight loss of up to 9.7%, 16.2%, and 22.0%, respectively.The weight loss percentages after placebo correction reached 12%, 18%, and 24%, respectively. In terms of safety, the side effects of Amycretin are similar to other incretin-based drugs.
AboutAmycretin
Amycretin is a drug developed by Novo Nordisk.Single-molecule long-acting GLP-1 receptor and amylin receptor agonist, aiming to provide efficient and convenient treatment options for overweight or obese adults as well as adult patients with type 2 diabetes.AmylinIt is another hormone related to hunger and satiety, apart from the GLP-1 signaling pathway.Studies show that amylin can reduce energy intake, regulate food choices and preferences, exert glucose regulation effects through co-secretion with insulin, inhibit postprandial glucagon release, and delay gastric emptying.In addition,Amylin receptors are also expected to synergize with GLP-1 receptor agonists.
AboutNovo Nordisk
Novo Nordisk was founded in 1923 and is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes, obesity, rare blood diseases, endocrine disorders, and other serious chronic diseases.