New Stock News | Exegenesis Bio Inc. has once again submitted an application to the Hong Kong Stock Exchange, laying out its therapeutic pipelines for neurological and ophthalmological gene treatments.

According to information from GMTEight APP and as disclosed by the Hong Kong Stock Exchange on August 28, Exegenesis Bio Inc. has submitted a listing application to the main board of the Hong Kong Stock Exchange, with CCB International serving as its exclusive sponsor. The company had initially filed on January 14, 2026. Company Profile According to the company's prospectus, Exegenesis Bio Inc. is a biopharmaceutical company focused on discovering and developing gene therapies for neurological and ophthalmic diseases. The company's pipeline also includes oligonucleotide-based therapies. Established in 2019, the company has built a pipeline with nine candidate products through its fully integrated in-house research and development platform. Using this platform, the company has internally developed two core products (EXG102031 and EXG001307 for SMA Type 1) and one key product (EXG202). EXG102031 is a candidate product for the treatment of wet age-related macular degeneration (wAMD), while EXG001307 is a candidate product for treating spinal muscular atrophy (SMA) Type 1. EXG202 is a candidate product designed for the treatment of retinal neovascular diseases, including wAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO). Regarding EXG102031, the company has conducted two clinical trials in China and the United States. In China, all subjects completed a 52-week follow-up for the Phase IIa trial by May 2026. The Phase IIb/III trial is expected to start in the second half of 2026. In the United States, the Phase I clinical trial has been completed, and the clinical database has been locked since March 20, 2026. For EXG001307 (SMA Type 1), the company has completed all Phase I/II clinical trials for SMA Type 1 patients. The company plans to discuss the design of a pivotal Phase III trial with regulatory authorities in the second half of 2026. EXG202 is currently being evaluated in two ongoing clinical trials in the United States and China. In the United States, the company received FDA IND approval in July 2025 and plans to utilize Phase I data generated in China to bypass the Phase I study conducted in the U.S. and directly enter Phase II trials. In China, the company received approval from the National Medical Products Administration in August 2025 to initiate a Phase I/II combined clinical study. The Phase IIa clinical trial began in March 2026, while the Phase IIb trial is expected to occur in the second half of 2026. The following diagram presents the pipeline of candidate products under development by Exegenesis Bio Inc. All candidate drugs listed in this pipeline diagram are discovered internally by the companys R&D team. Financial Information Revenue During the track record period, the companys research candidate products had not obtained regulatory or commercialization approval. For the years ending December 31, 2024, and for the six months ending June 30, 2025, and June 30, 2026, the company had no revenue. For the year ending December 31, 2025, the company recorded revenue of RMB 1.3 million, generated from providing R&D services to an overseas client (Client A). Client A hired the company to provide rAAV with the companys proprietary vector to test the impact of the companys vector on the efficacy of its product. Client A is a multinational pharmaceutical company. In 2025, Client A expressed interest in testing the companys proprietary capsid RtAAV001, leading to a Material Transfer Agreement (Material Transfer Agreement) established with the company in June 2025 to procure the relevant samples for preclinical studies (Study). According to the Material Transfer Agreement, the materials required for testing will be provided by the company and funded by Client A. Gross Profit and Gross Margin Gross profit refers to the company's revenue minus the cost of sales. The gross margin indicates the percentage of gross profit relative to revenue. During the track record period, the company had no gross profit for the year ending December 31, 2024, and for the six months ended June 30, 2025, and June 30, 2026. For the year ending December 31, 2025, the company recorded a gross profit of RMB 100,000, with a gross margin of 10.0%. R&D Expenses For the years ending December 31, 2024, and 2025, and for the six months ending June 30, 2025, and June 30, 2026, the R&D expenses related to the companys core products amounted to RMB 73.6 million, RMB 56.9 million, RMB 32.5 million, and RMB 28.2 million, accounting for 50.8%, 54.8%, 56.6%, and 52.8% of the companys total R&D expenses during the respective periods. Losses Exegenesis Bio Inc. recorded other income and losses of a net other income of RMB 200,000 for the six months ending June 30, 2025, while it reported a net other loss of RMB 1.9 million for the six months ending June 30, 2026, mainly due to increased foreign exchange losses from the depreciation of the U.S. dollar against the RMB. The companys annual loss increased from RMB 219.8 million in 2024 by RMB 607.1 million or 276.2% to RMB 826.9 million in 2025. Industry Overview The global gene therapy market is expected to grow from approximately USD 3.6 billion in 2025 to USD 12.5 billion by 2030, at a compound annual growth rate (CAGR) of 28.3%, and further increase to USD 32 billion by 2035, with a CAGR of 20.7% from 2030 to 2035. Between 2020 and 2025, no gene therapy products were launched in China. The Chinese gene therapy market is projected to grow from approximately RMB 0.0 billion in 2025 to RMB 3.2 billion by 2030, at a CAGR of 143.8%, and further expand to RMB 22.8 billion by 2035, with a CAGR of 48.3% from 2030 to 2035. The global SMA drug market is expected to grow from USD 3.0308 billion in 2020 to USD 4.7365 billion by 2025, with a CAGR of 9.3%, and is projected to reach USD 5.9319 billion by 2030, with a CAGR of 4.6% from 2025 to 2030, and further grow to USD 9.4469 billion by 2035, with a CAGR of 9.8% from 2030 to 2035. The Chinese SMA drug market is anticipated to rise from RMB 70 million in 2020 to RMB 587.9 million by 2025, at a CAGR of 53.1%, reaching RMB 1.6877 billion by 2030, with a CAGR of 23.5% from 2025 to 2030, and further increase to RMB 3.2945 billion by 2035, with a CAGR of 14.3% from 2030 to 2035. As of the latest practical date, there are two approved SMA drugs and four SMA candidate drugs in clinical development in China. Board Information The board of directors of Exegenesis Bio Inc. will comprise six directors, including three executive directors and three independent non-executive directors. Equity Structure On August 9, 2019, the major shareholders of Exegenesis Bio Inc., Dr. Wu, Dr. Ye, Ms. Wang, and Landes Therapeutics Ltd., entered into a concerted action agreement, allowing the companys major shareholders to act together consistently during board meetings and shareholders' meetings. Please also refer to the section History, Restructuring, and Company Structure Company Development and Major Equity Changes. As of the latest practical date, the companys major shareholders, Dr. Wu, Dr. Ye, Ms. Wang, and Landes Therapeutics Ltd., have the right to exercise or control the exercise of a total of 31.16% of the voting rights at the companys shareholders' meetings due to the concerted action arrangement. Following the completion of the [completion] (assuming [completion] has not been exercised and no further shares are issued under any pre-completion stock incentive plans or convertible loan agreements), Dr. Wu, Dr. Ye, Ms. Wang, and Landes Therapeutics Ltd. will no longer be deemed the company's major shareholders (as defined in the listing rules) but will remain the single largest shareholder group and will have the right to exercise or control the exercise of approximately 26.49% of the voting rights at the companys shareholders' meetings. Intermediary Team Exclusive Sponsor: CCB International Financial Limited Company Legal Advisors: Morgan Lewis & Bockius LLP, Morgan Lewis & Bockius LLP, Zhong Lun Law Firm, Ogier Legal Advisors for Exclusive Sponsor: Tian Yuan Law Firm, Jingtian Gongcheng Auditors and Reporting Accountants: Deloitte Touche Tohmatsu Independent Industry Advisors: Frost & Sullivan (Beijing) Consulting Co., Ltd. Compliance Advisors: Mango Financial Limited