TIDES Weekly | Global Peptide and Oligonucleotide Therapeutics Highlights (Nov 8–15)

November 2024Day 7，Radella Pharmac, Focused on Developing Innovative Therapies for Cardiometabolic Disorderseuticals Announces Top-Line Results of Phase Ⅰa Clinical Study of MD-18 for Obesity Treatment.

MD-18 was shown to be safe and well-tolerated at all dose levels, with no serious adverse events or discontinuations. The only treatment-related effects were mild and transient injection site reactions, establishing a favorable safety profile in humans. Notably, subjects receiving MD-18 exhibited consistent improvements in several metabolic parameters after 7 days, including reduced leptin levels, improved insulin sensitivity, and decreases in alanine aminotransferase (ALT), low-density lipoprotein cholesterol, and total cholesterol, none of which were observed in placebo patients. Meanwhile, subjects receiving MD-18Patients also reported a decrease in appetite.

About Radella Pharmaceuticals

RadeLLA Pharmaceuticals is a privately-backed clinical-stage biopharmaceutical company developing transformative therapies for cardiometabolic diseases and other conditions. The company focuses on providing curative solutions for patients and improving human health, successfully advancing its lead asset MD-18 into clinical trials while developing a series of follow-up assets to address other major therapeutic areas, including neurodegenerative diseases and fatty liver disease.

On November 8, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that SirnaomicsThe IND (Investigational New Drug) application for the Respiratory Syncytial Virus (RSV) mRNA vaccine, co-developed by the non-wholly owned subsidiary Dalin Bio – Dalin Vaccine (Guangzhou) Co., Ltd. ("Dalin Bio") and Hualan Biological Vaccine Co., Ltd. ("Hualan Vaccine"), has been accepted by the CDE.

AboutDami Bio

RNAimmune is a clinical-stage biotechnology company dedicated to the development of mRNA vaccines and therapeutics. Headquartered in Guangzhou International Bio Island, China, the company is committed to leveraging mRNA technology to provide innovative solutions for infectious diseases, cancer, and other health challenges to meet medical needs. RNAimmune possesses an AI-driven innovative technology platform and has filed 34 global patents, holding complete independent intellectual property rights. Its innovative technologies include novel lipid nanoparticles, replicon platforms, advanced delivery systems, and proprietary circular RNA platforms.

November 2024Day 8Hepa Thera announces positive updates from the clinical trial of its chronic hepatitis B siRNA new drug, HT-101. The latest 48-week follow-up data reveal the drug’s significant effect in reducing hepatitis B surface antigen (HBsAg) levels, with particularly remarkable performance observed under low-dose administration.

Trial data show that most subjects in the HT-101 dosing group who participated in the extended follow-up maintained a good reduction in HBsAg at 48 weeks. Particularly noteworthy is that in the 400mg dose group, one subject achieved an undetectable level of HBsAg by week 48 after receiving only two doses, with HBsAg levels continuing to decline.Clearance of g.

About Hepa Thera

Suzhou Hepa Thera Biotech Co., Ltd. was established in May 2021. It is a biotechnology company incubated by Fosun Pharma's New Drug Fund, focusing on the development of innovative drugs in the field of liver disease treatment. Hepa Thera leverages technologies such as RNA interference, antibodies, fusion proteins, and gene editing to address unmet needs in the treatment of liver diseases, including hepatitis B, non-alcoholic fatty liver disease, liver fibrosis, cirrhosis, and autoimmune liver diseases. The company collaborates with universities, research institutes, and biotechnology enterprises, adopting models such as co-development, contract research, licensing, and independent research for product development. It is expected to grow into an influential innovative enterprise in China's liver disease treatment sector.

On November 12, 2024, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that the investigational new drug SYS6026 injection, submitted by Jushi Biologics of CSPC Group, was approved for clinical trials. It is intended for the treatment of patients with high-grade squamous intraepithelial lesions (HSIL) related to human papillomavirus (HPV) types 16 and 18. This marks the first time the product has received IND approval in China.

According to publicly available data from CSPC Pharmaceutical Group, SYS6026 Injection is an mRNA therapeutic candidate vaccine targeting the early protein antigens E6 and E7 of human papillomavirus (HPV) subtypes 16 and 18. It is intended for the treatment of HPV16 and HPV18 subtype-positive solid tumors, including cervical cancer, cervical intraepithelial neoplasia, anal cancer, head and neck cancer, etc.

About CSPC

CSPC Holding Group Co., Ltd. was established in 1997. Through global innovation engagement, CSPC continuously delivers better innovative outcomes for human health. The company has built a diversified product portfolio, focusing on three major sectors: finished drugs, active pharmaceutical ingredients (APIs), and functional foods. It is also actively involved in the prevention and treatment of the coronavirus. The group’s mRNA COVID-19 vaccine is China’s first self-developed vaccine to receive emergency use authorization, with two other novel global therapeutic drugs approved for clinical trials.

November 2024December 12，Apollo Therapeutics Announces Exclusive Licensing Agreement with Sunshine Lake for the Development of APL-18881 (HEC88473). APL-18881 is a bispecific fusion protein targeting FGF21 and GLP-1 receptors, developed by Sunshine Lake.

According to the terms of the agreement, Dongyang Guangya Pharmaceuticals will retain the rights to develop, manufacture, and commercialize APL-18881 in China, while granting Apollo Therapeutics the rights to develop, manufacture, and commercialize the drug for all current and future indications in regions outside of China. In return, Dongyang Guangya Pharmaceuticals will receive an upfront payment of $12 million and up to $926 million in development, regulatory, and commercial milestone payments. The commercial milestone payments are contingent upon reaching specified annual sales thresholds in key markets. Additionally, Dongyang Guangya...The drug will receive tiered royalties ranging from high single-digit to low double-digit percentages of net sales.

Apollo Therapeutics is building a large and diversified pipeline of novel drug candidates, and APL-18881 will be the fifth project to advance to the clinical development stage. An Investigational New Drug (IND) application for APL-18881 has been submitted in the United States. Apollo Therapeutics will explore the drug's therapeutic potential across a range of potential indications in the cardiometabolic, liver, and related disease areas in clinical trials, with specific indications yet to be disclosed.

November 2024December 12Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as "Gan & Lee Pharmaceuticals," stock code: 603087.SH) announced that the company's independently developed oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) GZR18 Tablets Achieve Positive Results in Phase I Clinical Trial Among Healthy Chinese Subjects.

This Phase I clinical trial (CTR20240663) is a randomized, open-label, first-in-human study that enrolled a total of 92 subjects. It aims to evaluate the relative bioavailability, pharmacokinetics, pharmacodynamics, safety, and tolerability of GZR18 tablets in healthy adult Chinese subjects, as well as to assess the impact of food timing on the pharmacokinetics and pharmacodynamics of GZR18 tablets.Study, Safety, Tolerability Impact.

About GZR18

GZR18, developed by Gan & Lee Pharmaceuticals, is a long-acting GLP-1 RA that functions through a glucose concentration-dependent mechanism to enhance insulin secretion and effectively reduce blood glucose levels. GZR18 is available in two administration methods: injection and oral. The GZR18 injection is a GLP-1RA designed based on fatty acid acylation, with 94% homology to the human GLP-1 molecule. It is intended for glycemic control in adult patients with type 2 diabetes and weight management in obese or overweight individuals. Currently, it is undergoing Phase II clinical trials in China, and the first subject has completed dosing.

About Gan & Lee Pharmaceuticals

Gan & Lee Pharmaceuticals Co., Ltd. (Abbreviation: Gan & Lee Pharmaceuticals, Stock Code: 603087.SH), as the first high-tech biopharmaceutical company in China to master the technology for industrial-scale production of recombinant insulin analogs, possesses a complete insulin R&D pipeline.

November 2024Day 13，The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced that Novartis' Lutetium [177Lu] Texiveptide Injection has been submitted for new drug approval.The city's application has been accepted. The drug has been included in the priority review by the CDE and is intended for the treatment of metastatic castration-resistant prostate cancer with positive prostate-specific membrane antigen (PSMA).Metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have received androgen receptor pathway inhibitors and taxane-based chemotherapy.This drug is the first targeted radioligand therapy approved by the FDA for patients with castration-resistant prostate cancer, and this is the first time it has been submitted for marketing in China.

Lutetium [177Lu] Texivepitide (177Lu-PSMA-617) is a PSMA-targeted radioligand therapy that links PSMA-617 with the beta-emitting 177Lu, binding to prostate cancer cells expressing PSMA.The radiation energy released by 177Lu will radiate and kill tumor cells.

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 and innovative accessibility initiatives, we deliver high-value medicines that alleviate the greatest disease burdens on society. In the pursuit of new drugs, we persistently innovate, with our R&D investments consistently ranking among the top in 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.

November 202413Recently, Metsera announced the completion of a $215 million Series B financing to further advance its highly differentiated, clinical-stage portfolio of Nutrient-Stimulated Hormone (NuSH) analog peptides. Nutrient-Stimulated Hormones (NuSH), such as GLP-1, GIP, and GCG, which are secreted in response to food intake and influence appetite and metabolism by acting on the brain, represent a novel therapeutic approach targeting the pathogenesis of obesity with high efficacy against obesity. These hormones play a key regulatory role in maintaining the body's energy balance, controlling appetite, and influencing body weight.

Metsera Recently Announced Significant and Sustained Weight Loss Effects of Its GLP-1 Receptor Agonist MET-097i in Phase 1/2 Clinical Trials

On November 13, 2024, Eli Lilly announced the latest follow-up data from the Phase III clinical trial SURMOUNT-1 of tirzepatide for the treatment of prediabetes in individuals with obesity or overweight. The follow-up duration was up to 3 years (176 weeks), and the data was simultaneously published in the New England Journal of Medicine.

After 176 weeks of treatment, the proportions of patients progressing to type 2 diabetes in the tirzepatide treatment group and placebo control group were 1.2% and 12.6%, respectively, representing a 94% reduction in the risk of progression to type 2 diabetes. After discontinuation of treatment for 17 weeks, the proportions progressing to type 2 diabetes were 2.4% and 13.7%, respectively, indicating an 88% reduction in the risk of progression to type 2 diabetes. Following discontinuation, the proportion of patients progressing to type 2 diabetes increased more rapidly, suggesting that the treatment delayed disease progression but may not have fundamentally reversed the disease process. Nonetheless, it still played a significant role in delaying...Slowing the progression of type 2 diabetes remains highly significant.

AboutTirzepatide

Tirzepatide is a dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, capable of simultaneously activating signaling pathways mediated by both GLP-1 and GIP receptors. GIP and GLP-1 are natural incretin hormones that regulate blood glucose. Tirzepatide was approved by the U.S. FDA in May 2022.(Product name: Mounjaro), used in conjunction with diet and exercise control to improve blood sugar control in adult patients with type 2 diabetes. In November last year, tirzepatide receivedFDA Approval(Product name: Zepbound), used to help obese or overweight adult patients lose weight and maintain stable weight.

About Eli Lilly and Company

Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, production, and sale of medicines, committed to improving human health through innovation. Eli Lilly was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876, with the founder's dedication to producing high-quality medicines to meet real medical needs.