Fukang Pharma Submits Hong Kong IPO Application with Nationwide Rollout of Lead Drug Within Three Months

The Hong Kong Stock Exchange has accepted the listing application of another biopharmaceutical company.

On August 31, Fukang (Shanghai) Health Technology Co., Ltd. (“Fukang Pharma”) had its initial public offering (IPO) application accepted by the Hong Kong Stock Exchange, with ABC International, CMB International Capital, and Fosun International Capital serving as joint sponsors.

Fukang Pharma was established in 2015 and is a novel drug R&D enterprise that has entered the commercialization stage. Its core team boasts backgrounds from renowned domestic and international pharmaceutical companies such as Novartis and Huahai, and maintains collaborations with research institutions including the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.

Since its establishment, Fukang Pharma has completed multiple rounds of financing. In March 2025, the company secured RMB 98 million in its Series C financing round, reaching a post-money valuation of RMB 3.098 billion; in August 2025, it completed its Series C2 financing round of RMB 90 million, with a post-money valuation of RMB 3.188 billion, bringing the cumulative financing to approximately RMB 416 million. Major investors include prominent industry investors such as WuXi Biologics, Jointown Venture Capital, and Yingke Capital, as well as institutions including Beijing Xicheng, Wuhan Optics Valley, and Chongqing Pengshui.

Fukang Pharma focuses on the field of cancer treatment, while also laying out innovative drug development and commercialization in the fields of viral and aging-related diseases. The company is committed to meeting unmet clinical needs in the field of cancer treatment and reducing R&D risks through a diversified strategy.

Fukang Pharma has established a diverse portfolio of drug modalities, with its R&D pipeline covering small-molecule inhibitors targeting EGFR/HER2/HER4, PARP inhibitors, PD-L1/VEGF bispecific antibodies, PI3K inhibitors, CDK4/6 inhibitors, CFB inhibitors, THR-β agonists, and multiple bispecific antibody-drug conjugates (ADCs).

The prospectus reveals that Fukang Pharma has established a diversified product portfolio comprising one commercialized product, two core products, two key products, and twelve other investigational candidate drugs. Among the 16 candidate drugs, five are in Phase I/II clinical development, seven are in preclinical development, and four are generic drug candidates. Its research and development projects primarily focus on oncology, antiviral therapy, and anti-aging. While its core products are centered on oncology, they specifically emphasize broad-spectrum antineoplastic agents.

Among these, the company’s first commercialized product, Han Nai Jia® (neratinib maleate), is an orally administered tyrosine kinase inhibitor that effectively blocks the growth and proliferation of tumor cells. The product was launched on June 28, 2024, and achieved nationwide market coverage within three months. Its primary indication is for first-line intensified adjuvant therapy of HER2-positive breast cancer; when administered sequentially with trastuzumab, it more comprehensively blocks the HER2 signaling pathway, significantly reducing the risk of recurrence in HER2-positive patients.

Fukang Pharma’s oncology product pipeline covers solid tumors and hematologic malignancies with urgent unmet needs for innovative therapies both domestically and internationally, including breast cancer, lung cancer, cholangiocarcinoma, prostate cancer, pancreatic cancer, and gastric cancer. Its core products include CVL218, a second-generation highly selective PARP inhibitor with “Best-in-Class” potential for the treatment of advanced solid tumors, which has been granted Orphan Drug Designation by the FDA for cholangiocarcinoma and pancreatic cancer; CVL237, a dual highly selective PI3Kβ/δ inhibitor for PTEN-deficient solid tumors, which received approval for Phase II clinical trials in May 2025; as well as other “First-in-Class” innovative bispecific antibodies targeting solid tumors.

The company’s other core product, CVL009, is classified as a Class 2.4 improved new drug and is currently undergoing Phase II clinical trials in patients with non-small cell lung cancer harboring rare HER1 mutations, patients with HER2-positive gastric cancer and brain metastases, and in combination with capecitabine.

Fukang Pharma’s viral product pipeline includes drug development for various infectious diseases, such as COVID-19, respiratory syncytial virus (RSV), monkeypox virus, and yellow fever virus.。

Unlike pure R&D-focused biotech companies, Fukang Pharma adopts a dual-track strategy that equally emphasizes commercialization and clinical development. The company efficiently advances the commercialization of its products through collaborations with partners such as Henlius and Sinovac.

The Company adopts a “one drug, multiple indications” R&D model, covering multiple indications with a single drug and integrating the functions of the entire product pipeline into a single product. For example, based on Hannaijia®, the Company is developing CVL009 and expanding its new indications. Other candidate drugs adopting this model include CVL006 (a PD-L1/VEGF bispecific antibody) and CVL237 (a highly selective dual PI3Kβ/δ inhibitor for PTEN-deficient solid tumors).

According to the prospectus, the Company generated revenues of RMB 0, RMB 17.825 million, and RMB 34.675 million in 2023, 2024, and the first half of 2025, respectively, demonstrating a significant growth trend. The revenue was primarily derived from Han Nai Jia®, the Company’s first commercialized product.

The rapid commercialization of Han Nai Jia® marks the company’s successful transformation from a pure R&D enterprise into a commercial entity. However, as an innovation-driven enterprise, Fukang Pharmaceutical remains in a loss-making position. In 2023, 2024, and the first half of 2025, the company incurred losses of RMB 94.655 million, RMB 74.525 million, and RMB 35.934 million, respectively. This is primarily attributable to high R&D expenditures, a common characteristic among biotechnology companies. According to the prospectus, the company’s R&D investments amounted to RMB 54.43 million and RMB 24.42 million in 2024 and the first half of 2025, respectively.

Benefiting from the optimization of product sales structure and cost control, the company’s gross profit margin was approximately 58.4% in 2024, rising to 61.1% in the first half of 2025. However, due to continued investment, the net profit margin was approximately -418.1% in 2024 and improved to approximately -103.6% in the first half of 2025.

Overall, Fukang Pharmaceutical has achieved rapid revenue growth driven by the successful commercialization of its first product. However, as most of its drug candidates remain in preclinical or clinical stages, the company’s future sustainability will depend on the clinical progress, regulatory approvals, and competitive landscape surrounding its core products, CVL009 and CVL218.

With its upcoming listing in Hong Kong, Fukang Pharma is poised to leverage the capital markets to further accelerate its R&D and commercialization efforts. As a biopharmaceutical company that has already achieved commercialization and generated revenue, Fukang Pharma’s market performance is worth anticipating.