HC016 Achieves Dual IND Approvals in the U.S. and China, Accelerating Global Development of Innovative Cancer Immunotherapy

HC016 China-US IND Approved

New Year's Eve, also known as the Chinese Lunar New Year's Eve, is a traditional Chinese festival. It falls on the last night of the 12th month in the lunar calendar, marking the end of the old year.

On March 4, 2025, HC016 Lipid Complex Injection, the world's first TLR9 agonist based on lipid nanoparticle (LNP) delivery technology independently developed by Haichang Biotech, officially received clinical trial (IND) approval from China's National Medical Products Administration (NMPA). Previously, the drug had already obtained IND approval from the U.S. Food and Drug Administration (FDA) on January 18, 2025. Thus, HC016 has become the first LNP-delivered TLR9 agonist project in China to achieve dual IND approvals in both China and the United States, marking the entry of this breakthrough cancer immunotherapy into the global synchronized development phase, providing a novel solution for solid tumor treatment.

Dual Certification from Chinese and U.S. Regulatory Authorities: Innovative Technology Platform Receives International Endorsement

HC016 is based on Haichang Biotech's proprietary QTsome technology.^TMThe small nucleic acid drugs developed through the delivery technology platform are innovative in that they use LNP to target and deliver a novel TLR9 agonist, activating multi-dimensional anti-tumor immune responses involving T cells, macrophages, and NK cells, while leveraging circulating memory-type immune cells to establish a sustained monitoring and elimination mechanism for distant metastases.Previously, the drug became the world's first LNP-delivered TLR9 agonist project to pass FDA review, based on its significant tumor regression rate, metastasis suppression effects, and safety data demonstrated in preclinical studies.This efficient approval by the NMPA not only validates the scientific value of HC016 but also highlights the cutting-edge competitiveness of China's innovative pharmaceutical companies in the global nucleic acid drug sector.

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Breakthrough in Technical Bottleneck: From "Systemic Toxicity" to "Precision Immune Activation"

Traditional TLR9 agonists have long been difficult to develop into drugs due to challenges such as high off-target toxicity, low tumor enrichment, and a monotherapy response rate of less than 10%.HC016 Relying onQTsome^TMThree Breakthrough Improvements in Technical Implementation:

Precision Targeted Delivery:Achieving high-selective enrichment of drugs in tumor tissues through LNP carriers significantly reduces off-target effects on normal tissues, effectively controlling systemic toxicity risks.

Efficient Intracellular Release:QTsome^TMTechnological breakthrough specifically targets the intracellular mechanism of TLR9, significantly enhancing drug delivery efficiency and promoting target activation, achieving an order-of-magnitude optimization in effective dosage compared to traditional therapies. 

Lymphatic System Tracking:QTsome^TMUnique lymphatic tropism can precisely cover tumor metastasis pathwaysPathway, synchronously clearing primary lesions and micro-metastatic lesions, preclinical studies show its broad-spectrum solid tumor treatment potential.

Haichang Biotech: The "Chinese Business Card" in the Nucleic Acid Drug Field

As a national-level specialized and new "little giant" enterprise, Haichang Biotech has built three strategic pipelines covering small nucleic acid drugs, mRNA vaccines, and complex injectables. Injectable paclitaxel (albumin-bound) has been approved for marketing in more than 40 countries, including the EU, China, and the UK. The HC0301 small nucleic acid drug has completed dual IND applications in China and the US and entered global Phase II clinical trials, while the HC016 project received dual IND approval in China and the US. QTsome^TMThe technology has been successfully applied in areas such as the COVID-19 mRNA vaccine (FDA clinical approval) and cancer immunotherapy (HC016), forming a "single platform, multiple pipelines" R&D matrix.

Prospect: From the "Pan-Cancer" Vision to Clinical Translation

With the launch of clinical trials in China and the United States, Haichang Biotech will systematically evaluate the safety and efficacy of HC016 in patients with advanced solid tumors and explore the "pan-tumor" indication expansion pathway. Dr. Zhao Xiaobin, the founder of the company, stated: "The global development of HC016 demonstrates the clinical translation potential of nucleic acid delivery technology. We are actively collaborating with global clinical centers and pharmaceutical enterprise partners to pragmatically advance clinical research, while opening up collaborations to bring in strategic partners, so that this ‘Made in China’ innovative therapy can benefit patients as soon as possible."

About Haichang Biotech

Haichang Biotech, located in China Medical Valley, Hangzhou, is a national-level specialized and innovative "little giant" enterprise that integrates the research, production, and sales of pharmaceuticals, focusing on the technological innovation and development of biopharmaceuticals. The company adheres to its core values of "sharing, progress, truth-seeking, and pragmatism," with a focus 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 approvals from the FDA and NMPA and is undergoing global multi-center Phase II clinical trials. The IND for HC016 Lipid Complex Injection has been approved in both China and the US. The mRNA COVID-19 vaccine booster has received FDA approval for clinical trials, making it the first Chinese-produced mRNA vaccine product to obtain clinical approval in the US. The product pipeline covers areas such as anti-tumor, tumor immunotherapy, analgesia, and infectious disease prevention.