Tides Weekly | Global Peptide and Oligonucleotide Therapeutics News Roundup

On January 18, 2024, the clinical trial application for "Technetium [99mTc] Hydrazinonicotinamide Bis-Ark Peptide Injection," a Class 1 radiodiagnostic drug developed by Guangdong Radiowave Technology Co., Ltd. (hereinafter referred to as Radiowave), was accepted and publicly disclosed by the Center for Drug Evaluation of the National Medical Products Administration. This drug is the second Class 1 radiodiagnostic drug submitted for approval by Radiowave.

The novel specific SPECT/CT tumor imaging agent 99mTc-3PRGD2 (Technetium [99mTc] hydrazinonicotinamide polyethylene glycol bicyclic RGD peptide injection), independently developed by Raydio, is the first self-developed Class 1 innovative drug in China's nuclear medicine field and also the world’s first broad-spectrum tumor imaging agent for SPECT imaging diagnosis. It has transformed the technical status quo where nuclear medicine SPECT/CT imaging technology could not be utilized for tumor diagnosis, staging, and evaluation of therapeutic efficacy.

On January 22, 2024, Ionis Pharmaceuticals announced positive results from the Phase 3 OASIS-HAE study of its investigational antisense oligonucleotide (ASO) therapy, donidalorsen, for the treatment of patients with hereditary angioedema (HAE). The therapy met its primary endpoint, significantly reducing the rate of HAE attacks in patients. Based on these data, Ionis is preparing to submit a New Drug Application (NDA) to the U.S. FDA, while Otsuka, which holds exclusive commercialization rights to donidalorsen in Europe, is also preparing to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Ionis plans to present detailed results of the trial at a medical conference by mid-year.

About Ionis Pharmaceuticals, Inc.

For more than 30 years, Ionis has been a leader in the field of RNA-targeted therapeutics, pioneering new markets and transforming treatment standards. Ionis currently has four marketed drugs and a promising late-stage pipeline, focusing on cardiovascular and neurology franchises. Our scientific innovation began with and will continue as we know that patients rely on us, driving our vision to become a leader in genetic medicine by leveraging a multi-platform approach to discover, develop, and deliver life-changing therapies.

On January 24, 2024, Weierzhen Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as "Weierzhen" or "Visirna") recently announced that the investigational new drug VSA001 Injection (hereinafter referred to as VSA001) has successfully completed the enrollment of over 36 patients in the Phase III clinical trial for familial chylomicronemia syndrome (FCS) in China. The company plans to complete all endpoint evaluations of this clinical trial by the first quarter of 2025, supporting subsequent new drug registration and marketing applications. VSA001 is expected to become the first approved drug for FCS in China.

About Visirna

Visirna is a small nucleic acid drug therapy company based in China with a global outlook, aiming to build a biopharmaceutical enterprise with comprehensive capabilities from research and development, production to commercialization. Established in 2022, Visirna has formed a long-term strategic partnership with Arrowhead Pharmaceuticals (NASDAQ: ARWR), an internationally leading small nucleic acid drug company. Currently, the company's product pipeline includes three small interfering RNA drugs in clinical development, targeting cardiovascular and metabolic diseases.

Recently, "Lutetium Lu-177 dotatate Injection" (a Class 3 radioactive therapeutic drug) and "[64Cu]Cu-XT117 Injection" (a Class 1 radioactive diagnostic drug), developed by Beijing Xiantong International Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Xiantong Pharmaceutical), have respectively received the tacit approval for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration.

About Beijing Xiantong International Pharmaceutical Technology Co., Ltd.

Beijing Xiantong International Pharmaceutical Technology Co., Ltd., abbreviated as "Xiantong Pharma," was founded in 2005. It is an innovative pharmaceutical company specializing in the research and development, production, and clinical academic promotion of radiopharmaceuticals. The company leverages world-leading R&D resources in the fields of radiopharmaceuticals and bio-antibody drugs, with a strategic focus on targeted therapies and precision diagnostic radiopharmaceuticals for cancer, neurodegenerative diseases, and cardiovascular conditions. Through a combination of independent development and external collaboration, Xiantong Pharma has built a product pipeline that balances generic and innovative products while managing risk and return.

On January 23, 2024, EraCal Therapeutics announced a collaboration and licensing agreement with Novo Nordisk to develop and commercialize EraCal's investigational oral small molecule drug for the treatment of obesity.

According to the agreement, Novo Nordisk will obtain exclusive rights to develop and commercialize the project, while EraCal is eligible to receive up to 235 million euros in upfront payments, development and commercial milestones, as well as royalties following the product's market launch.

About Novo 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 conditions.

January 24, 2024DayHangzhou Xianweida Biotechnology Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies for metabolic diseases, today announced positive results from the four completed cohorts of the Phase I clinical trial of oral Ecnoglutide (XW004) tablets. Ecnoglutide is a long-acting glucagon-like peptide-1 (GLP-1) agonist with cAMP bias, currently under development for the treatment of type 2 diabetes and obesity indications. Oral Ecnoglutide is an oral formulation of Ecnoglutide.

About Xianweida

Xianweida is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for metabolic diseases. Its R&D pipeline includes first-in-class and best-in-class drug candidates, such as the long-acting GLP-1 peptide injectable Ecnoglutide (Phase III clinical trials), oral GLP-1 peptide Ecnoglutide (Phase I clinical trials), and the oral small-molecule GLP-1 receptor agonist XW014 (Phase I clinical trials). Xianweida has developed several patented technologies, including an oral peptide delivery platform and an inhaled protein delivery platform, and has established a series of drug candidates based on its core technology platforms.

January 2024On the 25th, the new drug clinical trial application (IND) for ARC01 (A002), a therapeutic cancer vaccine developed by Nanjing Aoluo Biotechnology Co., Ltd. (Aoluo Bio), a subsidiary of Grand Pharmaceutical (0512.HK), targeting human papillomavirus type 16 (HPV-16) positive advanced unresectable or recurrent/metastatic solid tumors, was approved by the National Medical Products Administration.

About OroBio

Visirna is the Group's global innovative mRNA technology platform. Relying on mature mRNA production processes, stable and efficient LNP delivery technology, and safe TriMix® adjuvant technology, it has established a broadly applicable and expandable R&D platform for the development of products related to tumor immunotherapy and infectious disease vaccines. The IND approval of ARC01 marks a significant advancement for the Group in the field of mRNA-based cancer treatment.

January 2, 2024On the 4th, Sirnaomics, an industry-leading biopharmaceutical company focused on exploring and developing RNAi therapies, published a research report on the novel mechanism of action of STP707, an RNAi-based anticancer therapy candidate, in the international academic journal NAR Cancer. STP707 is a peptide nanoparticle (PNP) formulation consisting of two active siRNA (small interfering RNA) inhibitors targeting TGF-β1 and COX-2, respectively, for intravenous therapy in solid tumors. This paper provides empirical support for the company's ongoing clinical research and also offers a solid basis for the combination therapy of STP707 with immune checkpoint inhibitors.

About Sirnaomics Ltd.

Sirnaomics is an RNA therapeutics biopharmaceutical company with candidate products in clinical and preclinical stages, focusing on exploring and developing innovative drugs for the treatment of indications with medical needs and significant market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics biopharmaceutical company to hold a substantial market position in both Asia and the United States.