Enkang Pharma Submits IPO Prospectus: Pioneering DRIP Inhibitor Platform and Inhaled Liposomal Therapies for Oncology
Enkang Pharmaceutical Technology is a spin-off company of the Hong Kong University of Science and Technology, focusing on the research and development of innovative oncology drug platforms and new drugs. The company possesses an inhaled liposomal formulation platform and a DRIP (DNA Replication Initiation Protein) inhibitor-based targeted oncology drug screening platform. The company’s first inhaled liposomal drug, ILC (inhaled liposomal cisplatin), for the treatment of small cell lung cancer, is about to enter Phase II clinical trials (multicenter international clinical trials in China and the United States). Another indication for this product, pulmonary metastasis of osteosarcoma in children, is also approaching Phase III clinical trials (multicenter international clinical trials in China and the United States). In addition, the company’s first-in-class small-molecule anti-tumor drug, CM2, is currently in the preclinical research stage, with various studies demonstrating that CM2 features broad-spectrum activity, high efficacy, and low toxicity.
In August 2018, the FDA approved the first liposomal inhalation formulation, ALIS (amikacin liposome inhalation suspension), for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). NTM lung disease is a rare and serious condition with increasing incidence and mortality rates year by year. ALIS is the first and only therapy approved by the U.S. FDA specifically for the treatment of NTM lung disease caused by MAC.
Liposomes, as a type of nanodrug carrier, have gained widespread recognition. Currently, dozens of nanocarrier-based drugs have been marketed. Nanocarrier drugs are particularly prominent in the research and development of treatments for tumors, autoimmune diseases, and viral diseases due to their targeted delivery and sustained-release properties. Notably, the development of inhalable liposomal formulations by Enkang Pharmaceutical is extremely rare. “Inhalable liposomal formulations present exceptionally high technical barriers. On one hand, because the drug is directly inhaled into the pulmonary capillaries, there are stricter requirements for particle size and materials,” said Zou Lan, Co-founder and CEO of Enkang Pharmaceutical Technology, in an interview with VCBeat.
Enkang Pharmaceutical was established in July 2017, with its subsidiaries, Intero Medicine and Enzhi Medicine, founded in 2014. “The company’s core technology originated from the translation of collaborative research achievements among universities,” stated Zou Lan. The core team at Enkang Pharmaceutical comprises research groups from the Hong Kong University of Science and Technology (HKUST), Hong Kong Baptist University (HKBU), and Macau University of Science and Technology (MUST). Among them, Professor Chun Liang, co-founder of the company, holds a Ph.D. in Biology from Brown University in the United States and conducted postdoctoral research at Cold Spring Harbor Laboratory. He is a tenured professor at HKUST and the Director of its Cancer Research Center. Professor Liang has been engaged in DNA replication-related research since 1988. As an internationally renowned scientist in the field of DNA replication, he has dedicated 30 years to studying the mechanisms of DNA replication and tumorigenesis. His research papers have been published multiple times in prestigious international journals such as Cell, Cancer Research, and Genes & Development.
Zou Lan, CEO and Co-founder of Enkang Pharmaceutical, brings over a decade of experience in managing R&D teams. She excels in communication, coordination, and resource integration, and has overseen major corporate initiatives including mergers, restructuring, and intellectual property transfers. The company’s other co-founder, Professor Jiang Zhihong, serves as Vice President of Macau University of Science and Technology and Director of the Institute for Applied Medicine and Health. Formerly a professor at Hong Kong Baptist University, he has conducted more than ten years of research in natural medicinal chemistry, molecular pharmacology, and anti-tumor antibiotics, publishing over 100 SCI-indexed papers in international academic journals. Additionally, the company’s scientific advisory team comprises experts and professors specializing in liposomal formulations, pharmacology and toxicology, drug regulatory review, and renowned oncology hospitals.
“Initially, Professor Liang Chun and Professor Jiang Zhihong led their respective university teams in conducting research on different modules. They shared findings on an irregular basis, discussed them online, and held face-to-face meetings when necessary,” said Zou Lan. “Although the teams were based in different locations, they maintained close communication, a model that has persisted to this day.” Subsequently, as scientific achievements progressed step by step, Inter Pharma and Enzhi Pharma were established in succession. Inter Pharma secured the rights to the inhalable liposomal drug ILC for the China region, while Enzhi Pharma completed the transfer of intellectual property rights for its independently developed novel anti-tumor drug CM2 from the Hong Kong University of Science and Technology (HKUST) to the company. The company also secured angel financing from investors including Xinghui Holdings.
In 2017, the team established an inhaled liposome platform and a DRIP inhibitor-based targeted tumor drug screening platform, leading to the discovery of several inhaled liposomal drugs. In the same year, the team completed its Series A financing with Yuexiu Financial Holdings and Guangzhou Fund, while Intellipharmaceutics and Enzhi Pharma completed their restructuring, resulting in the establishment of Enkang Pharmaceutical.
Enkang Pharmaceutical’s core R&D platforms include an inhaled liposomal formulation platform and a DRIP inhibitor-based innovative targeted oncology drug screening platform. The inhaled liposomal formulation platform was established based on inhaled liposomal cisplatin, which the company introduced from the United States through technology licensing-in (“License in”). To date, the company has developed eight new inhaled liposomal drugs using this platform and holds eight invention patents. “In contrast, conventional injectable or oral medications for pulmonary diseases reach the lungs via the pulmonary capillaries. However, pulmonary vascular distribution is not uniform; consequently, a portion of the drug fails to reach and act on the lesion sites through systemic circulation. Moreover, most conventional inhaled powders or aerosols are largely deposited in the upper respiratory tract and cannot penetrate deeply into the lower respiratory tract,” explained Zou Lan.
Inhaled liposomal formulations effectively address the challenge of pulmonary drug delivery accessibility. Taking ILC, a core inhaled liposomal drug developed by Enkang Pharmaceutical, as an example, this formulation distributes evenly throughout the lungs after nebulized inhalation. Compared with the renal concentration of cisplatin following intravenous injection, the lung concentration achieved with the ILC formulation is several times higher than its concentration in the kidneys. Furthermore, regarding safety, inhaled liposomal formulations encapsulate drugs within biodegradable, non-toxic biomaterials, thereby causing less damage to lung tissue. “Compared with conventional injectable cisplatin, the safety profile of ILC is improved by more than fourfold,” disclosed Zou Lan. This formulation can fuse with alveolar membranes, delivering the drug into cells and enabling slow, sustained release, which allows the dosing interval to be extended to two weeks.
“The DRIP Inhibitor-Based Innovative Targeted Oncology Drug Screening Platform is an independently developed innovative cancer drug screening platform by Enkang Pharmaceutical. ‘In simple terms, DRIP is a novel target that plays a crucial role in distinguishing tumor cells from non-tumor cells. Drugs identified through the DRIP inhibitor platform can effectively attack tumor cells while sparing the vast majority of normal cells. This is the true unique advantage of the DRIP platform,’ explained Zou Lan.”
Anticancer cell cycle agents inhibit tumor cell proliferation or induce apoptosis by affecting nucleic acid biosynthesis, disrupting DNA structure and function, or interfering with protein synthesis. However, these drugs also cause apoptosis in normal proliferating cells. DRIP inhibitors have addressed this challenge. Furthermore, according to Zou Lan, anticancer drugs screened using the DRIP inhibitor platform have demonstrated inhibition rates exceeding 90% against various human-derived tumors in animal models. CM2, an anticancer drug identified through this platform, has already filed more than ten patents domestically and internationally and is currently undergoing preclinical studies for multiple tumor indications.
“DRIP inhibitor platform drugs will represent a new class of oncology therapeutics,” stated Zou Lan. “As combination therapy emerges as a new trend in cancer treatment, cell cycle–targeting agents hold significant potential for use in combination with other antineoplastic modalities, such as cell therapy and immunotherapy. The DRIP inhibitor platform confers target specificity and selective activity against cancer cells to cell cycle–targeting agents, thereby enhancing efficacy while reducing adverse effects.”
In advancing its core technology platforms and products, Enkang Pharmaceutical has engaged in basic research collaborations with institutions such as the First Affiliated Hospital of Guangzhou Medical University, Sun Yat-sen University Cancer Center, Guangzhou University of Chinese Medicine, Peking University Health Science Center, and the First Affiliated Hospital of Sun Yat-sen University. Meanwhile, the company has commissioned international CRO firms to assist with clinical drug trials. Enkang is also seeking international strategic partnerships to jointly advance the global multi-center development of CM2.
Currently, Enkang Pharma is undergoing its Series B financing round. The funds will be used to advance the global multicenter clinical trials of its first-in-class drug candidate CM2, support the simultaneous global R&D of ILC for small cell lung cancer and pulmonary metastasis in pediatric osteosarcoma, and drive the development of multiple pipelines across its two core platforms. Additionally, the funds will be allocated to recruiting talent with international clinical project management experience.
Yuexiu Fund stated, “As research into innovative oncology drugs deepens, new drugs categorized as ‘me-too,’ ‘me-better,’ or ‘fast-follow-on’ are gradually losing their appeal. Among existing oncology therapeutics, immune-oncology agents and kinase inhibitors dominate the market. Although research into cell cycle-related drugs is less active, breakthroughs in this area hold significant potential. Enkang Pharmaceutical’s independently developed DRIP inhibitor-based innovative targeted oncology drug screening platform can identify First-in-class candidates with high tumor inhibition rates, demonstrating excellent potential for combination therapies and positioning it as a leader in cell cycle-related oncology drug research. The company’s inhaled liposome novel formulation platform features substantial barriers to entry and holds a leading position both domestically and globally. Compared with inhaled powders, dry powder inhalers, and injectable liposomal formulations, it offers superior safety and efficacy in the treatment of pulmonary diseases. The company’s founding follows a typical American biotech startup trajectory. From its EU-standard laboratories to its low-profile, pragmatic core team deeply engaged in innovative oncology drug development, we are highly optimistic about Enkang Pharmaceutical and the growth potential of its sector.”