Cloudbreak Pharma Files for Hong Kong IPO Again with Focus on Ophthalmology Pipeline

On June 11, 2025, the Hong Kong Stock Exchange's official website showed,Cloudbreak Pharma Inc.Hereinafter referred to as:Cloudbreak Pharma）Submitted an application for listing on the Hong Kong Stock Exchange, planning to go public in Hong Kong,CCB International and Huatai International are the joint sponsors.

Source of the image: HKEX official website

The prospectus shows,Cloudbreak PharmaCloudbreak Pharma is a clinical-stage ophthalmic biotechnology company dedicated to developing various therapies, with a particular focus on the field of ophthalmic diseases.

Cloudbreak Pharma has two core products (CBT-001 and CBT-009), both of which are self-developed.

The core product CBT-001, applicable for the treatment of pterygium (a benign proliferative ocular surface disease), has initiated Phase 3 multi-regional clinical trials in the United States and China in June 2022 and September 2023, respectively.

Core product CBT-009, used for treating juvenile myopia (myopia in children and adolescents aged 5 to 19), completed Phase 1/2 clinical trials in January 2023, and a new drug clinical trial application was submitted to the U.S. Food and Drug Administration in July 2024.

Other candidate drugs are in relatively early stages of development, including two clinical-stage candidates, CBT-006 (For the treatment of dry eye syndrome associated with meibomian gland dysfunction）and CBT-004 (For the treatment of vascularized pterygium）；

And four preclinical-stage candidate drugsCBT-007 (for improving the success rate of glaucoma filtration surgery), CBT-199 and CBT-145 (new formulations and new chemical entities for presbyopia treatment, respectively), and CBT-011 (an ADS conjugate for treating diabetic macular edema).

ItsTwo proprietary technology platforms have been developed, namely the Multi-Kinase Inhibitor ("Multi-Kinase Inhibitor") and Antibody-Drug Synergy ("ADS") platforms, which are used to develop candidate drugs for treating anterior and posterior eye diseases, respectively.

Cloudbreak Pharma PipelineFigure;ComeSource: Prospectus

Currently,Cloudbreak PharmaFour rounds of investments have been completed: (i) Series A financing, raising approximately RMB 10.0 million; (ii) Series B financing, raising a total of approximately USD 17.1 million through Series B-1 and Series B-2 financings; (iii) Series C financing, raising approximately USD 127.0 million; and (iv) Mok Ka Ying's acquisition of shares from CNCB (one of the original Series C investors), with no proceeds received as no new shares were issued.

Source of the image: Prospectus

Financial PartyFace,As of the years ended December 31, 2022, 2023, and 2024, its annual losses were USD 66.8 million, USD 129.4 million, and USD 99.1 million, respectively.

Among them, in terms of R&D investment, for the years ended December 31, 2022, 2023, and 2024, its R&D expenditures were $15.3 million, $27.5 million, and $37.9 million, respectively.

Source of the image: Prospectus

Ni Dr. Jinsong,Ms. Bing Leng (NiDr. Jinsong(Spouse)Water Lily Consultants, Ni Legacy Trust, Ice Tree LLC, Ice Tree Consultants, and Leng Legacy Trust are the largest single shareholder of the company.

The prospectus shows,NI JinsoDr. Ng, 57, serves as the Chairman of the Board, Executive Director, Chief Executive Officer, and one of the largest single shareholders. He was appointed as a director on November 20, 2020, and subsequently appointed as Chairman of the Board and re-designated as an Executive Director on November 9, 2023. Dr. Ng is responsible for overseeing the group's overall drug development, daily operational management, as well as strategic and business development.

Dr. Ni, together with Mr. Dinh and Dr. Li, co-founded the group in September 2015, establishing Cloudbreak USA, the group's first major operating subsidiary at that time. Dr. Ni was one of the founding shareholders of Cloudbreak USA and served as one of its managers from December 2015 to December 2021.

Dr. Ni has over 30 years of experience in the life sciences industry. Prior to joining the group, Dr. Ni served as a postdoctoral researcher in the Department of Medicinal Chemistry at the University of Utah College of Pharmacy from November 1994 to October 1996. In October 1996, he subsequently joined the American Health Foundation as a research scientist. From October 1997 to May 2000, he worked as a research scientist at Pfizer Inc. From May 2000 to June 2015, he served as the Scientific Director of the Drug Safety Evaluation Department at Allergan, Inc.

Dr. Ni obtained his Ph.D. in Philosophy from the University of Toronto, Canada, in June 1995. He received his M.Sc. in Chemistry from Brock University, Canada, in June 1992, and graduated with a B.Sc. in Chemistry from Nanjing University, China, in July 1989.