New Stock News | Frontera Therapeutics files for Hong Kong Stock Exchange, dedicated to developing innovative gene therapies based on recombinant adeno-associated viruses (rAAV).

According to a disclosure by the Hong Kong Stock Exchange on December 23, Frontera Therapeutics has submitted its listing application to the main board of the Hong Kong Stock Exchange. UBS Securities Hong Kong Limited and Haitong International Capital Limited are its joint sponsors. The prospectus shows that since its establishment in 2019, the company has been committed to independently developing innovative recombinant adeno-associated virus ("rAAV") gene therapy. The company has developed a differentiated and clinically advanced pipeline with the best global potential for eye and cardiovascular diseases in particular. Company Overview According to the prospectus, Frontera Therapeutics is a clinical-stage gene therapy company focused on the development of innovative therapies, with an international business layout dedicated to providing safe, effective, and affordable gene therapy solutions to patients worldwide. As of the last practical feasibility date (December 16, 2025), Frontera Therapeutics' product pipeline includes eight independently developed rAAV gene therapy candidates, including (i) two core products, FT-002 (a potential best-in-class candidate drug being studied for the treatment of X-linked retinitis pigmentosa) and FT-003 (a potential best-in-class candidate drug being studied for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) through intravitreal injection); (ii) a key product, FT-001 (a gene therapy candidate drug for the treatment of genetic retinal diseases caused by RPE65 gene biallelic mutations); and (iii) five other gene therapy candidate drugs in preclinical and early stages for the treatment of ophthalmic, cardiovascular, and neurological diseases. The competitive advantages of Frontera Therapeutics are as follows: a differentiated gene therapy pipeline supported by robust clinical data with the best global potential; AAVANCETM, the company's Bac/Sf9 production platform, enabling safe, scalable, cost-effective, and high-quality production; leveraging the advantage of its international layout, possessing strong translational medicine and clinical operational capabilities; EXACTETM, the company's proprietary rAAV gene therapy research platform, supporting the development of innovative products protected by global intellectual property rights; and possessing deep gene therapy expertise in research, translation, clinical, and production disciplines. Frontera Therapeutics has built an agile and well-coordinated R&D team. As of September 30, 2025, the company's internal R&D team consists of 37 efficient members located in China and the United States. Early-stage innovation and preclinical research can seamlessly progress to clinical trials, with very few delays. Through collaborations with leading hospitals and research institutions, Frontera Therapeutics has been able to achieve efficient site initiation and protocol deployment. This infrastructure supports faster participant enrollment and more clinical data, which is crucial for accelerating the development speed. The company was able to move a candidate drug from lead identification to IND approval in just 11 months. To date, Frontera Therapeutics has received 12 IND approvals from the National Medical Products Administration and the FDA, making it the leading rAAV gene therapy development company in China in terms of IND approvals, according to Frost & Sullivan data. Since its establishment, the company has successfully advanced three candidate drugs to Phase II clinical trials. As of the last practical feasibility date, Frontera Therapeutics has not yet obtained marketing approval for any candidate drug, nor has it generated any revenue from product sales. Financial Information Research and development expenses The company's research and development expenses for the fiscal years 2023, 2024, and the nine months ended September 30, 2025, were approximately $27.585 million, $20.576 million, and $10.969 million, respectively. Losses for the year/period For the fiscal years 2023, 2024, and the nine months ended September 30, 2025, the company reported losses of approximately $35.86 million, $26.464 million, and $13.311 million, respectively. Industry Overview The global gene therapy market has seen rapid growth in recent years, reaching a market size of $2.8 billion in 2024. From 2020 to 2024, the market experienced exponential growth, with a compound annual growth rate of 312.9%. Looking ahead, the global market is expected to grow at a compound annual growth rate of 24.7% from 2024 to 2035, reaching a market size of $32 billion in 2035. The Chinese gene therapy market is also poised for rapid growth. In 2024, the market size for gene therapy in China was minimal. The market is expected to grow at a compound annual growth rate of 53.4% from 2025 to 2035, reaching a market size of RMB 11.6 billion in 2035. rAAV gene therapy uses rAAV vectors to deliver target genes to target cells, which are then transcribed and translated into functional proteins. As of the last practical feasibility date, there are nine approved rAAV gene therapy drugs globally. These drugs typically focus on rare diseases and have high production and treatment costs. Six of the approved drugs are produced using the HEK293 system, while three are produced using the Bac/Sf9 system. There are over 200 rAAV gene therapy drugs in development worldwide. However, most of these candidate drugs are still in the early stages of clinical exploration, with approximately 57% in combined Phase I/II clinical trials and 22% in standalone Phase I clinical trials. The number of drugs entering the late-stage clinical phase is increasing, but still relatively limited. Around 6% of the pipeline is in Phase II clinical trials, about 10% in Phase III clinical trials, approximately 3% in combined Phase II/III clinical trials, and only four drugs have reached the biologics license application stage. In recent years, rAAV gene therapy has become a promising treatment option for several ophthalmic diseases, especially retinal neovascular diseases. The global ophthalmic drug market grew from $33.5 billion in 2020 to $41.6 billion in 2024, with a compound annual growth rate of 5.6%. It is projected to continue growing at a compound annual growth rate of 4.2% from 2024 to 2035, reaching a size of $65.6 billion in 2035. In comparison, the growth rate of the Chinese ophthalmic drug market is faster and is expected to maintain its growth momentum. The Chinese ophthalmic drug market grew from RMB 18.8 billion in 2020 to RMB 29.5 billion in 2024, with a compound annual growth rate of 11.9% from 2020 to 2024. The market is expected to reach RMB 91.2 billion in 2035, with a compound annual growth rate of 10.8% from 2024 to 2035. Board of Directors Information Frontera Therapeutics' board of directors consists of nine directors, including one executive director, five non-executive directors, and three independent non-executive directors. According to the company's articles of association, the term of office for directors is three years and they may be re-elected. The board of directors is responsible for and has general powers to manage and conduct the company's affairs. Ownership Structure As of the last practical feasibility date, OrbiMed Asia Partners III, L.P.'s general partner is Orbi Med Asia GP III, L.P., and OrbiMed Advisors III Limited is its general partner. As of the last practical feasibility date, OrbiMed Private Investments VII, LP's general partner is OrbiMed Capital GP VII LLC, and OrbiMed Advisors LLC is its managing member. OrbiMed Advisors LLC is the advisor to OrbiMed Asia and has voting rights under its advisory agreement with OrbiMed Asia. OrbiMed Advisors LLC also has controlling voting rights over OrbiMed Private Investments VII, LP. Therefore, OrbiMed Asia and OrbiMed Private Investments VII, LP are jointly controlled by OrbiMed Advisors LLC. Intermediary Team Joint Sponsors: UBS Securities Hong Kong Limited, Haitong International Capital Limited Industry Consultant: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch Joint Sponsors and Legal Advisors: Smithfield & Globe Law Firm Company Legal Advisors: Sidley Austin LLP and Affiliates, Wilson Sonsini Goodrich & Rosati LLP, Zhong Lun Law Firm, Horizons Law Firm Auditors and Reporting Accountants: Deloitte Touche Tohmatsu Compliance Consultant: Tongren Financing Limited Company