NewTimeSpace | "The First AAV Gene Therapy Stock", Frontera Therapeutics Files for Hong Kong IPO

Recently, the holding company of Frontera Therapeutics (Shanghai) Co., Ltd. (referred to as "Frontera Therapeutics") filed a prospectus with the HKEX, seeking a listing on the Main Board of Hong Kong under Chapter 18A of the Hong Kong Listing Rules. UBS Group and Guotai Haitong act as joint sponsors.

A Gene Therapy Company with 3 Products in Clinical Stages

Public data shows Frontera Therapeutics was founded in 2019 as a clinical-stage gene therapy company specializing in the development of rAAV gene therapies. It is committed to providing innovative, high-quality, and affordable treatment solutions for patients with major diseases such as ophthalmic and cardiovascular diseases worldwide.

To date, Frontera Therapeutics operates in both China and the United States, having built a complete R&D ecosystem covering R&D centers, GMP production bases, and clinical operations centers. It has assembled a core team with profound backgrounds in new drug R&D and efficient clinical transformation capabilities.

Frontera Therapeutics currently has 8 self-developed rAAV gene therapy candidates, 3 of which have entered clinical stages.

Two core products, FT-002 and FT-003, have made significant progress. FT-002, for the treatment of XLRP, has been granted FDA Orphan Drug Designation and Fast Track Designation. It is currently undergoing Phase II clinical trials in China and has received FDA approval for Phase II studies in the US.

FT-003 is an intravitreal gene therapy for nAMD and DME. It is the only intravitreal gene therapy in Phase II clinical trials for DME and one of seven global therapies in Phase II for nAMD, with Phase II trials approved in both China and the US.

Key product FT-001, for IRD caused by RPE65 mutations, obtained the National Medical Products Administration (NMPA) Breakthrough Therapy Designation in June 2025, and its Phase III clinical trial protocol was approved in September of the same year.

In addition, Frontera Therapeutics has five preclinical and early-stage candidates targeting diseases such as nAMD, diabetic retinopathy, HCM, and ARVC, continuously expanding its layout in ophthalmology, cardiovascular, and neurological fields.

The prospectus shows Frontera Therapeutics has obtained 12 IND approvals from the NMPA and FDA, making it the Chinese company with the most IND approvals for rAAV gene therapies, according to Frost & Sullivan.

No Revenue Yet; Cumulative Losses Exceed US$70 Million in Three Years

As a clinical-stage enterprise, Frontera Therapeutics has not yet generated any revenue.

The prospectus reveals that R&D expenses for 2023, 2024, 2024, and the first nine months of 2025 were US$27.585 million, US$20.576 million, US$17.344 million, and US$10.969 million respectively, with corresponding net losses of US$34.569 million, US$25.594 million, US$21.134 million, and US$14.505 million.

Calculations by NewTimeSpace Research Institute show that R&D expenses accounted for 79.80%, 80.39%, 82.07%, and 75.62% of the period losses during the reporting period. Cumulative losses over the past three years reached US$74.668 million.

Employee expenses accounted for 38.3%, 37.1%, 37.3%, and 30.3% of R&D expenses respectively, according to the prospectus.

As of September 30, 2025, Frontera Therapeutics' internal R&D team consists of 37 members based in China and the US, over 54% of whom hold doctoral or master's degrees, with expertise in medicine, biology, pharmacology, chemistry, and other related fields.

The prospectus indicates Frontera Therapeutics has received multiple government grants in the past, mainly related to the innovative nature of its business and compensation for capital expenditures.

For the years ended December 31, 2023 and 2024, government grants recognized as other income were US$0.8 million and US$0.5 million respectively. For the nine months ended September 30, 2024 and 2025, they were US$0.08 million and US$0.4 million respectively.

Growing Industry Scale; Post-Money Valuation Nearing RMB 4 Billion Three Years Ago

Frost & Sullivan reports that the global gene therapy market has experienced rapid growth in recent years, reaching a market size of US$2.8 billion in 2024. From 2020 to 2024, the market underwent an exponential growth phase with a CAGR of 312.9%. Looking ahead, the global market is expected to grow at a CAGR of 24.7% from 2024 to 2035, reaching US$32 billion by 2035.

China's gene therapy market is also poised for rapid growth. In 2024, the market size was minimal, but it is projected to grow at a CAGR of 53.4% from 2025 to 2035, reaching RMB11.6 billion by 2035.

Furthermore, public-private partnerships in China have promoted the development of commercial insurance covering gene therapy drugs, which is expected to further drive market growth. In December 2025, the National Healthcare Security Administration released the "Commercial Health Insurance Innovative Drug Catalog," covering 19 innovative drugs with significant clinical benefits not covered by public medical insurance, including several gene therapy drugs. Drugs included in the catalog are expected to supplement public medical insurance and be covered by commercial health insurance, including people-benefiting insurance supervised by the government and operated by private institutions.

The prospectus shows Frontera Therapeutics has completed Series A, Series B-1, and Series B-2 financings, with investors including renowned institutions such as Boyu Capital, HSG Growth, OrbiMed Asia, OrbiMed US, Hongyuan Capital, and Hongling Capital.

It raised US$35 million in Series A financing in 2021 and US$163 million in Series B financing in 2022, totaling US$198 million in funding. The post-money valuation after the 2022 Series B financing was US$528 million, approximately RMB3.702 billion.

Prior to the IPO, OrbiMed Capital and Hongyuan Capital are founding shareholders, holding approximately 32.58% and 27.71% of the shares respectively. Other shareholders include Boyu Capital, Sequoia Capital, Zhengxinggu Capital, Denoma, Starr International, and Hongling Capital.

The proceeds from Frontera Therapeutics' Hong Kong IPO are intended to fund the ongoing clinical R&D activities of core products FT-002 and FT-003; cover preparation costs for the commercialization of candidate drugs in China, including regulatory filings and the establishment of sales and marketing capabilities; support R&D of early-stage pipeline projects and other R&D-related costs; invest in production capacity to prepare for the market approval and commercialization of candidate drugs, including any necessary facility upgrades in the future; and be used for working capital and other general corporate purposes.

A Gene Therapy Company with 3 Products in Clinical Stages

Public data shows Frontera Therapeutics was founded in 2019 as a clinical-stage gene therapy company specializing in the development of rAAV gene therapies. It is committed to providing innovative, high-quality, and affordable treatment solutions for patients with major diseases such as ophthalmic and cardiovascular diseases worldwide.

To date, Frontera Therapeutics operates in both China and the United States, having built a complete R&D ecosystem covering R&D centers, GMP production bases, and clinical operations centers. It has assembled a core team with profound backgrounds in new drug R&D and efficient clinical transformation capabilities.

Frontera Therapeutics currently has 8 self-developed rAAV gene therapy candidates, 3 of which have entered clinical stages.

Two core products, FT-002 and FT-003, have made significant progress. FT-002, for the treatment of XLRP, has been granted FDA Orphan Drug Designation and Fast Track Designation. It is currently undergoing Phase II clinical trials in China and has received FDA approval for Phase II studies in the US.

FT-003 is an intravitreal gene therapy for nAMD and DME. It is the only intravitreal gene therapy in Phase II clinical trials for DME and one of seven global therapies in Phase II for nAMD, with Phase II trials approved in both China and the US.

Key product FT-001, for IRD caused by RPE65 mutations, obtained the National Medical Products Administration (NMPA) Breakthrough Therapy Designation in June 2025, and its Phase III clinical trial protocol was approved in September of the same year.

In addition, Frontera Therapeutics has five preclinical and early-stage candidates targeting diseases such as nAMD, diabetic retinopathy, HCM, and ARVC, continuously expanding its layout in ophthalmology, cardiovascular, and neurological fields.

The prospectus shows Frontera Therapeutics has obtained 12 IND approvals from the NMPA and FDA, making it the Chinese company with the most IND approvals for rAAV gene therapies, according to Frost & Sullivan.

No Revenue Yet; Cumulative Losses Exceed US$70 Million in Three Years

As a clinical-stage enterprise, Frontera Therapeutics has not yet generated any revenue.

The prospectus reveals that R&D expenses for 2023, 2024, 2024, and the first nine months of 2025 were US$27.585 million, US$20.576 million, US$17.344 million, and US$10.969 million respectively, with corresponding net losses of US$34.569 million, US$25.594 million, US$21.134 million, and US$14.505 million.

Calculations by NewTimeSpace Research Institute show that R&D expenses accounted for 79.80%, 80.39%, 82.07%, and 75.62% of the period losses during the reporting period. Cumulative losses over the past three years reached US$74.668 million.

Employee expenses accounted for 38.3%, 37.1%, 37.3%, and 30.3% of R&D expenses respectively, according to the prospectus.

As of September 30, 2025, Frontera Therapeutics' internal R&D team consists of 37 members based in China and the US, over 54% of whom hold doctoral or master's degrees, with expertise in medicine, biology, pharmacology, chemistry, and other related fields.

The prospectus indicates Frontera Therapeutics has received multiple government grants in the past, mainly related to the innovative nature of its business and compensation for capital expenditures.

For the years ended December 31, 2023 and 2024, government grants recognized as other income were US$0.8 million and US$0.5 million respectively. For the nine months ended September 30, 2024 and 2025, they were US$0.08 million and US$0.4 million respectively.

Growing Industry Scale; Post-Money Valuation Nearing RMB 4 Billion Three Years Ago

Frost & Sullivan reports that the global gene therapy market has experienced rapid growth in recent years, reaching a market size of US$2.8 billion in 2024. From 2020 to 2024, the market underwent an exponential growth phase with a CAGR of 312.9%. Looking ahead, the global market is expected to grow at a CAGR of 24.7% from 2024 to 2035, reaching US$32 billion by 2035.

China's gene therapy market is also poised for rapid growth. In 2024, the market size was minimal, but it is projected to grow at a CAGR of 53.4% from 2025 to 2035, reaching RMB11.6 billion by 2035.

Furthermore, public-private partnerships in China have promoted the development of commercial insurance covering gene therapy drugs, which is expected to further drive market growth. In December 2025, the National Healthcare Security Administration released the "Commercial Health Insurance Innovative Drug Catalog," covering 19 innovative drugs with significant clinical benefits not covered by public medical insurance, including several gene therapy drugs. Drugs included in the catalog are expected to supplement public medical insurance and be covered by commercial health insurance, including people-benefiting insurance supervised by the government and operated by private institutions.

The prospectus shows Frontera Therapeutics has completed Series A, Series B-1, and Series B-2 financings, with investors including renowned institutions such as Boyu Capital, HSG Growth, OrbiMed Asia, OrbiMed US, Hongyuan Capital, and Hongling Capital.

It raised US$35 million in Series A financing in 2021 and US$163 million in Series B financing in 2022, totaling US$198 million in funding. The post-money valuation after the 2022 Series B financing was US$528 million, approximately RMB3.702 billion.

Prior to the IPO, OrbiMed Capital and Hongyuan Capital are founding shareholders, holding approximately 32.58% and 27.71% of the shares respectively. Other shareholders include Boyu Capital, Sequoia Capital, Zhengxinggu Capital, Denoma, Starr International, and Hongling Capital.

The proceeds from Frontera Therapeutics' Hong Kong IPO are intended to fund the ongoing clinical R&D activities of core products FT-002 and FT-003; cover preparation costs for the commercialization of candidate drugs in China, including regulatory filings and the establishment of sales and marketing capabilities; support R&D of early-stage pipeline projects and other R&D-related costs; invest in production capacity to prepare for the market approval and commercialization of candidate drugs, including any necessary facility upgrades in the future; and be used for working capital and other general corporate purposes.

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