IPO News | FronteraTherapeutics once again submitted to the Hong Kong Stock Exchange to further develop the RAAV ophthalmology gene therapy race

The Zhitong Finance App learned that according to the Hong Kong Stock Exchange's disclosure on August 28, FronteraTherapeutics (Frontera for short) submitted a listing application to the main board of the Hong Kong Stock Exchange, with UBS Group and Haitong International as co-sponsors. The company first submitted a statement on December 23, 2025.

Company profile

According to the prospectus, the company was incorporated in 2019. It is a clinical-stage gene therapy company dedicated to independently developing recombinant adeno-associated virus (rAAV) gene therapy. Frontera's pipeline is particularly focused on ophthalmology and cardiovascular diseases.

As of the last practical date, the company's product pipeline includes six self-developed rAAV gene therapy candidates, including (i) two core products, FT‑002 (a drug candidate currently being studied to treat X-linked retinitis pigmentosa (“XLRP”)) and FT‑003 (a drug candidate, which is being studied to treat neovasculous senile macular degeneration (“NaMD”) and diabetic macular edema (“DME”) through intravitreal injections; (ii) a key product, FT‑001 (one for the treatment of treatment of X-linked retinitis pigmentosa (“XLRP”) gene therapy candidates for hereditary retinal diseases (“IRD”) (“RPE65 related IRD”) due to double allele mutations in the RPE65 gene); and (iii) three other pre-clinical and early-stage gene therapy candidates for the treatment of ophthalmology and cardiovascular diseases.

The image below shows the gene therapy pipeline the company is developing:

FronteraTherapeutics stated that its competitive advantages are as follows: differentiated gene therapy pipeline, leading in clinical progress in China; AAVANCE™, the company's Bac/Sf9 production platform to achieve safe, scalable and cost-effective high-quality production; using the company's layout in China and the US, it has strong translational medicine and clinical operation capabilities; EXACTE™, the company's rAAV gene therapy R&D platform, supports product development protected by global intellectual property rights; in research and transformation We have deep expertise in gene therapy in clinical and production disciplines.

FronteraTherapeutics has established an internal R&D team. As of June 30, 2026, it consists of 37 members, spread across China and the US. More than 56% of them have doctorate or master's degrees. The main fields of expertise are medicine, biology, pharmacology and chemistry, and other related fields. The average R&D team of the company has more than ten years of industry experience. The members of the R&D team have deep scientific talents and rich experience in multinational pharmaceutical companies. Notably, the company's research leadership team has rich past experience in gene therapy research and has a good track record in promoting the development of gene therapy drugs.

As of the last practical date, FronteraTherapeutics has not obtained marketing approval for any drug candidates, nor has it generated any revenue from product sales.

Financial data

R & D expenses

For the year ended 2024 and December 31, 2025, the company's R&D expenses were US$20.6 million and US$13.9 million respectively, accounting for 74.6% and 73.1% of the company's total operating expenses (defined as the sum of R&D expenses and general and administrative expenses for the corresponding year), respectively. For the six months ended 2025 and June 30, 2026, the company's R&D expenses were USD 7.1 million and USD 5.3 million respectively, accounting for 72.4% and 68.6% of the company's total operating expenses, respectively. For the year ended 2024 and December 31, 2025, and for the six months ending June 30, 2026, the company recorded R&D expenses of US$8.4 million, US$5.1 million and US$1.1 million respectively in the US, which together accounted for 36.5% of the company's total R&D expenditure during the track record period.

Loss for the year/period

For the year ended 2024 and December 31, 2025, the company recorded net losses of $26.5 million and $19.5 million, respectively, while net losses of $8.2 million and $4.7 million were recorded for the six months ended 2025 and June 30, 2026, respectively. The change in net loss was mainly due to a reduction in R&D expenses.

Industry Overview

The global gene therapy market has recorded rapid growth over the past few years, reaching a market size of 3.6 billion dollars in 2025. From 2020 to 2025, the market experienced a period of exponential growth, with a compound annual growth rate of 226.6%. Looking ahead, the global market is expected to grow at a CAGR of 28.1% from 2025 to 2030, and reach a market size of $12.5 billion by 2030. The market is expected to grow further to $32 billion in 2035, with a compound annual growth rate of 20.8% from 2030 to 2035.

In 2025, China's gene therapy market is still at a very early stage, with a total market size of about RMB 40 billion. The market is expected to grow at a CAGR of 143.8% from 2025 to 2030, and reach a market size of RMB 3.2 billion by 2030. The market is expected to grow further to RMB 22.8 billion in 2035, with a CAGR of 90.1% from 2030 to 2035.

AAV is a single-stranded DNA virus, and both ends of its genomic DNA are reverse terminal repetition (“ITR”) sequences required for the initiation of DNA replication and packaging of recombinant AAV virus particles. Between the ITR sequences is the virus coding region, which contains the two genes Rep and Cap. Among them, the Rep gene is mainly responsible for the replication of the viral genome and its integration with the host genome, while the Cap gene is mainly responsible for the packaging of the viral genome and its secretion from host cells.

As of the last practical date, there are over 250 rAAV gene therapy drugs under investigation, five of which are in the BLA phase. Development is still focused on early clinical exploration: approximately 53% are in phase I/II trials to verify safety, initial efficacy, and dose exploration. Independent phase I studies accounted for another 27%, reflecting a steady influx of drug candidates for first-time human trials. Late-stage activities are emerging but are still moderate — Phase III projects account for 10% of the pipeline, Phase II accounts for 6%, and Phase II/III accounts for 3%. Rare diseases and ophthalmic diseases account for the majority of the global rAAV gene therapy pipeline. Treatment for rare diseases accounts for more than half of all rAAV gene therapy drugs under study. Meanwhile, as far as treatment is concerned, ophthalmic diseases are the most important target field. Other promising fields include neuromuscular, cardiovascular, and hematologic diseases.

In recent years, rAAV gene therapy has become a promising treatment option for several ophthalmic diseases (especially fundus neovascularization diseases). Compared to other treatment options, rAAV gene therapy has several key advantages, making it possible to meet existing unmet medical needs.

The global ophthalmic drug market has maintained steady growth over the past 5 years, from US$33.5 billion in 2020 to US$44.1 billion in 2025, with a compound annual growth rate of 5.7%. The global ophthalmic drug market is expected to approach $49.4 billion by 2030 and reach $65.5 billion by 2035, with a compound annual growth rate of 2.3% from 2025 to 2030, and 5.8% CAGR from 2030 to 2035.

Currently, there are no rAAV-based gene therapy products approved for the same indications as the company's core products.

Board Information

FronteraTherapeutics's board of directors consists of nine directors, including one executive director, five non-executive directors, and three independent non-executive directors. According to the Articles of Association, the term of office of the company's directors is three years and they can be re-elected. The company's board of directors is responsible for and has general powers to manage and conduct the company's business.

Shareholding structure

As of the last practical date, the general partner of OrbiMed Asia Partners III, L.P. (“Aobo Asia”) is OrbiMed Asia GP III, L.P., and OrbiMed Advisors III Limited is its general partner. As of the last practical date, the general partner of OrbiMed Private Investments VII, LP (“Aobo America”) is OrbiMed Capital GP VII LLC, and OrbiMed Advisors LLC is its managing member. OrbiMed Advisors LLC is Aobo Asia's consulting company and has voting rights under its advisory agreement with Aobo Asia. OrbiMed Advisors LLC also has controlling voting rights over Aobo America. As a result, Aobo Asia and Aobo America are jointly controlled by OrbiMed Advisors LLC.

Intermediary team

Co-sponsors: UBS Securities Hong Kong Limited, Haitong International Capital Limited

Company Legal Advisors: Shida International Law Firm and Affiliates, Wilson Sanzini Gucci Rosaldi Law Firm, Zhong Lun Law Firm, Hengli Law Firm

Co-sponsor legal advisors: Smith & Phil Kemer & Global Law Offices

Reporting accountant and auditor: Deloitte Guan Huang Chen Fang

Industry Advisor: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch