Joinn Laboratories Supports HC Bioscience's HC016 Lipid Complex Injection in Securing FDA IND Approval

Jan 23, 2025 17:06 CST Updated 17:06

JOINN

Contract Research Organization (CRO)

Haichang Biotech

Innovative Formulation Developer

January 18, 2025, Haichang Biotech (hereinafter referred to as: Haichang Biotech)Haichang Biotech's Self-Developed HC016 Lipid Complex Injection Receives FDA IND Approval. This drug isThe First Lipid Nanoparticle (LNP)-Delivered Toll-Like Receptor 9 (TLR9) Small Nucleic Acid Immunostimulant,AdoptedQTsome^TMCore technology, self-developed lipid nanoparticle (LNP) delivery system, used for the treatment of various solid tumors including melanoma, head and neck cancer, and osteosarcoma. The approval of HC016 fully demonstrates the competitiveness and potential of China's self-developed core drug innovation technology on the international stage.

Image Source: Haichang Biotech Official Website

About TLR9 Agonists

The TLR family in the human body consists of 10 members (TLR1-10). Among them, TLR9 is located in intracellular vesicles and participates in recognizing nucleic acid components of microorganisms. It can recognize specific nucleotide motifs—CpG ODN—in bacterial and viral DNA, inducing inflammatory responses and Th1-type immune responses in the body. Currently, three types of CpG ODN have been validated: types A, B, and C. Type A primarily induces type I interferons IFNα/β; type B can activate B cells to produce antibodies; type C possesses characteristics of both types A and B, meaning it can activate B cells and also stimulate pDCs to produce IFNα, promoting the activation and maturation of APCs and NK cells.

HC016, an innovative TLR9 agonist developed by Haichang Biotech, demonstrates enhanced activation effects on core components of anti-tumor immunity, including T cells, macrophages, and NK cells. Circulating memory-type immune cells effectively monitor and eliminate distant metastases and circulating tumor cells.

JOINN Supports Clients in FDA IND Submission

JOINN participates in the innovative R&D process of HC016 small nucleic acid and undertakes thePreclinical Pharmacokinetics and Safety EvaluationPreclinical data shows,QTsome^TMThe delivery system enables the drug to effectively accumulate at the tumor site, with almost no significant upregulation of cytokines in the blood. This addresses the safety issues that traditional TLR9 agonists have struggled to overcome, while significantly reducing the effective dosage, alleviating the medication burden on patients in later stages, and minimizing the risk of adverse reactions.

JOINN Has Significant Advantages in FDA IND Applications. The company possesses comprehensive international qualifications, including GLP certifications from the FDA, NMPA, OECD, etc., with industry-leading qualification completeness. Equipped with advanced facilities and multiple experimental sites, JOINN can conduct a large number of experiments simultaneously. With rich industry experience and professional expertise, JOINN has extensive experience in evaluating innovative biotechnology applications, providing high-quality preclinical research services to clients, and offering strong support for FDA IND applications.

About Haichang Biotech

Haichang Biotech, located in China Medical Valley, Hangzhou, is a national specialized and innovative "little giant" enterprise that integrates the research, production, and sales of pharmaceuticals, with a primary focus on the technological innovation and development of biopharmaceuticals. The company adheres to its core values of "sharing, progress, truth-seeking, and pragmatism," centering on the development and industrialization of drug delivery systems. It specializes in the development of nucleic acid innovative drugs such as small nucleic acid drugs, mRNA vaccines, and complex injectables. Currently, injectable paclitaxel (albumin-bound) has been approved in nearly 40 countries, including China, the UK, and the EU, with ongoing registration in multiple Belt and Road countries. HC0301, a novel class 1 small nucleic acid drug, has received dual clinical trial approval from the FDA and NMPA and is undergoing global multi-center Phase II clinical trials. The mRNA COVID-19 vaccine booster has been approved for clinical trials by the FDA, marking it as the first Chinese-produced mRNA vaccine product to receive U.S. clinical approval. The product pipeline covers areas such as anti-tumor treatments, tumor immunotherapy, pain relief, and infectious disease prevention.

JOINN Laboratories (Stock Code: 603127.SH/6127.HK) is one of the earliest Contract Research Organizations (CROs) in China specializing in non-clinical drug evaluation. Since its establishment in 1995, JOINN has built a professional technical team of nearly 2,500 people. The company operates under an internationally compliant quality management system (CNAS/ILAC-MRA certification) and holds GLP qualifications from China’s NMPA, the U.S. FDA, OECD, Korea’s MFDS, Japan’s PMDA, as well as international AAALAC (animal welfare) accreditation, ensuring its evaluation reports meet global drug registration requirements. JOINN provides clients with comprehensive services including non-clinical pharmacology and toxicology research and evaluation, particularly non-clinical safety evaluation, clinical trials, and pharmacovigilance. It also offers evaluation services for veterinary drugs, pesticides, and medical devices. JOINN has subsidiaries in Beijing, Suzhou, Chongqing, Guangzhou, Shanghai, Wuzhou, Nanning, Yunnan, as well as in California and Boston in the United States.

JOINN adheres to the mission of "serving drug innovation, focusing on safety evaluation and monitoring throughout the drug lifecycle" to ensure patient medication safety and care for human health!

Serving drug innovation, focusing on safety evaluation and monitoring throughout the drug lifecycle, ensuring patient medication safety, and caring for human health!

Website：http://www.joinnlabs.com

E-mail：info@joinnlaboratories.com