Tongli Biopharma Secures Tens of Millions RMB Financing to Advance Clinical Development of TL-010, a Broad-Spectrum Anti-Zoonotic Infectious Disease Drug

VCBeat (WeChat ID: vcbeat) has learned that Suzhou Tongli Biomedical Co., Ltd. (hereinafter referred to as “Tongli Biomedical”) recently announced the completion of a new round of financing,Exclusively led by Hangzhou Tigermed Equity Investment Partnership, a subsidiary of Tigermed, with Tianchao Capital serving as the financial advisor for this round of financing.The proceeds from the financing will be primarily used to advance the clinical trials and scale-up manufacturing of the company’s candidate drug “TL-010” for combating zoonotic infectious diseases.

Previously, Tongli Biomedical completed its first round of financing in 2017, raising RMB 10 million, with joint investment from Shanghai Jingtong Investment Management Center and Taifu Capital.

Tongli Biomedical is a high-tech enterprise dedicated to innovation in biomedicine, R&D, and the promotion of product commercialization. Since its establishment in 2012, the company has been focused on developing solutions for serious threats to global public healthZoonotic Infectious DiseasesRelated diagnostic and therapeutic products. TL-010, the flagship product independently developed by Tongli Biomedical, has successfully completed preclinical druggability assessment, process optimization for the active pharmaceutical ingredient (API) and tablets, and clinical batch production. The company has filed for and obtained multiple invention patents in China, the United States, and other countries. Tongli Biomedical has sequentially received approval from the U.S. Food and Drug Administration (FDA) and the South African Health Products Regulatory Authority (SAHPRA) for its Investigational New Drug (IND) application for TL-010.Successfully initiated and completed Phase I clinical trials for an international new drug in 2019.Currently, the company plans to actively seek commercial partners and manufacturers for joint development, with the expectation of accelerating the regulatory submission and market launch of TL-010 in the United States, China, and other countries through the FDA’s 505(b)(2) abbreviated clinical development and approval pathway, and ultimately securing its inclusion on the WHO Model List of Essential Medicines.

Tropical infectious diseases generally refer to a range of illnesses caused by parasites, bacteria, or viruses. According to WHO estimates, there are more than 17 common neglected tropical diseases (NTDs) worldwide, including schistosomiasis, foodborne parasitic diseases (such as clonorchiasis, paragonimiasis, and cysticercosis), as well as cestode infections and echinococcosis (hydatid disease). These diseases are prevalent in nearly 100 tropical and subtropical countries globally, affecting approximately 1.4 billion people.

Schistosomiasis is contracted through skin contact with contaminated water sources in endemic areas, such as domestic water supplies and flood-related secondary disaster zones. It can induce chronic anemia and inflammation, severely impairing the physiological development of children and adolescents, potentially leading to physical and mental disabilities. Food-borne trematodiasis includes clonorchiasis and paragonimiasis, among others. Infection occurs through the consumption of raw or underprocessed freshwater fish (e.g., “yusheng” or raw fish dishes) and crabs, making it the most prevalent food-borne zoonotic disease. Globally, there are 20 million infected individuals, primarily distributed across Guangdong and Guangxi provinces in China, as well as Southeast Asian countries including Vietnam, Thailand, South Korea, and the Russian Far East.

It is now well established that liver flukes are Class I biological carcinogens, and chronic infection can lead to cholangiocarcinoma. Additionally, echinococcosis is a zoonotic parasitic disease caused by Echinococcus tapeworms parasitizing humans or animals such as dogs. Dogs serve as the primary source of infection, while humans, cattle, sheep, and other animals act as intermediate hosts. Characterized by a long incubation period and high case-fatality rate, echinococcosis is also known as “parasitic cancer.” Of the 200,000 new cases reported globally each year, more than half occur in various regions of Northwest China. In recent years, with urbanization, changes in modern lifestyles, and recurrent flooding disasters, some urban residents have become infected through easily overlooked transmission routes, such as consuming contaminated raw aquatic products and meat, or coming into contact with pets and contaminated water.

Over the past three decades, innovative drugs for treating the aforementioned diseases have been exceedingly rare. In light of this, the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) have in recent years classified these conditions as neglected tropical infectious diseases, introducing preferential policies and expedited review pathways to encourage pharmaceutical companies to develop innovative therapies for these often-overlooked diseases. Notably, TL-010, a candidate from Tongli Biomedical, received orphan drug designation from the U.S. FDA in June 2017 for the treatment of schistosomiasis.

Dr. Qian Mingxin, founder of Tongli Biomedical, graduated early in his career from the Department of Clinical Medicine at Chongqing Medical University. In 1988, he earned his M.D. degree at one of China’s first doctoral programs in infectious diseases and at the Ministry of Health’s Clinical Pharmacology Base for Infectious Diseases. During his doctoral studies, he conducted a series of chemical, pharmacological, and clinical trial studies on anti-infective agents, including those for schistosomiasis. He subsequently completed postdoctoral training in pharmaceutical sciences in the United States and held positions in drug discovery, preclinical, and clinical pharmacology departments at multinational pharmaceutical companies such as Bristol-Myers Squibb and Genentech, where he participated in the research, development, and regulatory submission for market approval of various small-molecule and large-molecule drugs.

In 2008, Dr. Qian Mingxin returned to China to help establish the preclinical division of Shanghai WuXi AppTec, serving as Vice President. Recognizing the persistently high global incidence of schistosomiasis, with hundreds of millions of patients still lacking adequate medical care and medications, and in response to the World Health Organization’s call for the development of better drugs to control and eliminate this tropical infectious disease, he founded Tongli Biomedical with the support of angel investors. The company focuses on the development of TL-010, aiming to address the poor medical compliance associated with existing marketed drugs, pollution from manufacturing processes, and global supply shortages through an environmentally friendly biocatalytic-chemical combination technology platform.

Dr. Qian Mingxin“The clinical trial results indicate that TL-010 tablets offer convenient oral administration, a favorable safety profile, and pharmacokinetic behavior of the parent drug and its metabolites consistent with expectations. They demonstrate greater clinical advantages over marketed drugs, marking a significant milestone in the company’s global development journey for TL-010. We will collaborate with domestic and international pharmaceutical companies and CDMOs interested in entering high-standard international markets, adhering to the requirements of expedited regulatory pathways such as the FDA’s Orphan Drug designation and the 505(b)(2) development pathway. Our goal is to complete scale-up manufacturing of pre-commercialization batches, process validation, and necessary streamlined clinical trials within two years. Upon market approval, we aim to secure WHO prequalification, facilitate inclusion in the WHO Model List of Essential Medicines, and enable procurement by multiple countries.”

“We believe that TL-010 can be widely used in the treatment of various forms of schistosomiasis and food-borne trematodiases, addressing the current global shortage of public health medications for these conditions. It has the potential to become the first-line therapy for schistosomiasis and other parasitic diseases in the 21st century, thereby benefiting impoverished patients. Beyond generating certain economic returns, it offers significant social benefits in terms of public health prevention and control, as well as enhancing international brand influence. We are deeply honored to have received recognition and investment from Tigermed’s investment team in this financing round. This underscores Tigermed’s discerning vision, grounded in its industry reputation, experience, and capabilities, as well as its commitment to sustainable development goals and corporate social responsibility. By actively participating in and supporting efforts to address global public health disparities, Tigermed identifies and invests in innovative diagnostic and therapeutic products and enterprises with substantial clinical value.”

Currently, Tongli Biomedical has established a professional R&D team and an academic advisory team with a global perspective. In addition to deepening its presence and strategic layout in the diagnosis, treatment, prevention, and control of zoonotic infectious diseases, and actively seeking partners for the commercial production of active pharmaceutical ingredients (APIs) and tablets post-listing, the company also plans to expand and extend its existing differentiated product pipeline through further financing and business collaborations, while actively exploring and entering other specialized niche sectors such asBiomarkers, Molecular Diagnostics for Infectious Diseases, and Animal Health – Broad-Spectrum Veterinary Anthelminticsdevelopment, etc., providing diagnostic and therapeutic product solutions to address global public health needs and unmet clinical demands in underdeveloped countries.

Tigermed (Stock Code: ChiNext: 300347, H Shares: 03347) is a contract research organization (CRO) dedicated to providing comprehensive professional services for the entire clinical trial process in new drug development. It delivers integrated and thorough clinical research services and solutions to global pharmaceutical and medical device innovators, thereby reducing R&D risks, shortening development cycles, cutting R&D costs, and accelerating product commercialization, so that patients can gain earlier access to newer and better pharmaceutical and medical products.

Tianchao Capital is a boutique investment bank focused on the healthcare and wellness sector, providing investment banking services such as equity financing, mergers and acquisitions, divestitures, licensing and joint ventures, and cross-border transactions. The company is committed to value discovery and creation, focusing on high-quality enterprises with technological or business model breakthroughs, and serving those that embody the spirit of “natural selection and transcending limits.”

Since its establishment, the company has served dozens of clients across fields including new drug R&D, medical devices, medical diagnostics, high-value consumables, healthcare services, and emerging technologies, with total service revenue exceeding billions of yuan or the equivalent in U.S. dollars.

As a bridge connecting capital with high-quality enterprises, as well as linking the domestic and international markets, Tianchao Capital is committed to providing professional, dedicated, high-quality, and efficient services. We strive to secure diverse resources—including funding, technology, and strategic partners—for enterprises on a global scale, thereby accelerating their rapid growth.