Based on the disclosure to the Hong Kong Stock Exchange on August 28, Exegenesis Bio Inc. has submitted a listing application for the Main Board, with CCB International serving as its sole sponsor. The company initially filed its application on January 14, 2026.

Company Overview

According to its prospectus, Exegenesis Bio Inc. is a biopharmaceutical firm dedicated to discovering and developing gene therapies for neurological and ophthalmic disorders. Its pipeline also encompasses oligonucleotide-based therapies. Founded in 2019, the company has leveraged its fully integrated internal R&D platform to build a pipeline of nine candidate products. Through this platform, it has internally developed two core products (EXG102-031 and EXG001-307 (SMA Type 1)) and one key product (EXG202).

EXG102-031 is a candidate for treating wet age-related macular degeneration (wAMD), while EXG001-307 (SMA Type 1) targets spinal muscular atrophy (SMA) Type 1. EXG202 is designed to address fundus neovascular diseases, including wAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO).

Regarding EXG102-031, two clinical trials have been conducted in China and the United States. In China, all subjects completed the 52-week follow-up of the Phase IIa trial in May 2026, with the Phase IIb/III trial expected to commence in the second half of 2026. In the United States, the Phase I trial has been completed, and the clinical database has been locked since March 20, 2026.

For EXG001-307 (SMA Type 1), all Phase I/II clinical trials involving SMA Type 1 patients have been finished. The company plans to initiate discussions with regulatory authorities regarding the design of the pivotal Phase III trial in the second half of 2026.

EXG202 is currently being evaluated in two ongoing clinical trials in the U.S. and China. In the U.S., the company received FDA IND approval in July 2025 and intends to utilize Phase I data generated in China to bypass a U.S. Phase I study and proceed directly to a Phase II trial. In China, it obtained NMPA approval in August 2025 to initiate a combined Phase I/II clinical study. The Phase IIa trial was launched in March 2026, with the Phase IIb trial expected to take place in the second half of 2026.

Financial Data

During the track record period, none of the company's investigational candidates received regulatory approval or reached commercialization. As a result, the company generated no revenue for the year ended December 31, 2024, and the six months ended June 30, 2025 and 2026. For the year ended December 31, 2025, it posted revenue of RMB 1.3 million, derived from providing R&D services to an overseas client ("Client A"). Client A engaged the company to supply rAAV with the company's proprietary vector to test the vector's impact on its product efficacy. Client A is a multinational pharmaceutical company.

In 2025, Client A expressed interest in testing the company's proprietary capsid RtAAV001, leading to a material transfer agreement in June 2025 to procure relevant samples for preclinical research. Under this agreement, the company supplies the required materials, funded by Client A.

Gross Profit and Margin

Gross profit is defined as revenue minus cost of sales, with gross margin representing gross profit as a percentage of revenue. During the track record period, no gross profit was recorded for the year ended December 31, 2024, and the six months ended June 30, 2025 and 2026. However, for the year ended December 31, 2025, the company achieved a gross profit of RMB 100,000, translating to a gross margin of 10.0%.

R&D Expenditure

R&D expenses for core products totaled RMB 73.6 million, RMB 56.9 million, RMB 32.5 million, and RMB 28.2 million for the years ended December 31, 2024 and 2025, and the six months ended June 30, 2025 and 2026, respectively, accounting for 50.8%, 54.8%, 56.6%, and 52.8% of total R&D costs in the respective periods.

Losses

The company reported net other income of RMB 200,000 for the six months ended June 30, 2025, but swung to a net other loss of RMB 1.9 million for the six months ended June 30, 2026, mainly due to increased net foreign exchange losses from the depreciation of the U.S. dollar against the yuan. Annual losses surged by RMB 607.1 million, or 276.2%, from RMB 219.8 million in 2024 to RMB 826.9 million in 2025.

Industry Outlook

The global gene therapy market is projected to expand from approximately $3.6 billion in 2025 to $12.5 billion by 2030, reflecting a CAGR of 28.3%, and further to $32 billion by 2035, with a CAGR of 20.7% from 2030 to 2035. In China, no gene therapy products were launched between 2020 and 2025. The Chinese market is expected to grow from roughly RMB 0.0 billion in 2025 to RMB 3.2 billion by 2030, a CAGR of 143.8%, and to RMB 22.8 billion by 2035, a CAGR of 48.3%.

The global SMA drug market rose from $3.03 billion in 2020 to $4.74 billion in 2025, a CAGR of 9.3%, with forecasts of $5.93 billion by 2030 (4.6% CAGR) and $9.45 billion by 2035 (9.8% CAGR). China's SMA drug market grew from RMB 70 million in 2020 to RMB 587.9 million in 2025, a CAGR of 53.1%, and is expected to reach RMB 1.69 billion by 2030 (23.5% CAGR) and RMB 3.29 billion by 2035 (14.3% CAGR). As of the latest practicable date, China had two approved SMA drugs and four SMA candidates in clinical development.

Board Structure

The board of Exegenesis Bio Inc. will consist of six directors: three executive directors and three independent non-executive directors.

Shareholding Structure

On August 9, 2019, the controlling shareholders—Dr. Wu, Dr. Ye, Ms. Wang, and Landes Therapeutics Ltd—entered into a concert party agreement, acting together by unifying their votes at board meetings and shareholder gatherings. As of the latest practicable date, these parties collectively hold the right to exercise or control 31.16% of voting rights at shareholder meetings. Following the [REDACTED] completion (assuming no exercise of the [REDACTED] and no further share issuance under pre-[REDACTED] equity incentive plans or convertible loan agreements), Dr. Wu, Dr. Ye, Ms. Wang, and Landes Therapeutics Ltd will cease to be controlling shareholders (as defined by listing rules) but will remain the single largest shareholder group, exercising or controlling approximately 26.49% of voting rights.

Advisory Team

The sole sponsor is CCB International Capital Limited. Company legal advisors include Morgan Lewis, Zhong Lun Law Firm, and Ogier. Sponsor legal advisors are Tian Yuan Law Firm and Jingtian & Gongcheng. The auditor and reporting accountant is Deloitte Touche Tohmatsu. The independent industry consultant is Frost & Sullivan (Beijing) Consulting Co., Ltd., and the compliance advisor is Mango Financial Limited.