Recently, another biomedical company, GenFleet Therapeutics, has successfully passed the Hong Kong Stock Exchange listing hearing, signaling that the Hong Kong stock market is set to welcome another 18A company.

Since the beginning of this year, the top 5 companies with the highest first-day gains among new Hong Kong stock listings have all been 18A companies. Consequently, the market has been holding great expectations for every 18A company listing recently.

GenFleet Therapeutics was established in 2017 as a biopharmaceutical company focused on developing new treatment solutions for oncology (covering different treatment lines across various solid tumors) as well as autoimmune and inflammatory diseases. Prior to its listing, GenFleet Therapeutics underwent multiple funding rounds, backed by a large group of renowned venture capital institutions including Shenzhen Capital Group (SDIC), CDH Investments, and Huagai Capital.

**Loss of Commercial Control Over Core Products**

According to the prospectus, GenFleet Therapeutics has currently established a product pipeline comprising eight drug candidates, with five in clinical development stages, including two core products - GFH925 and GFH375.

GFH925 (fulzerasib, trade name Daber®) is a novel drug independently discovered by GenFleet Therapeutics, which has received commercial approval in China for treating advanced non-small cell lung cancer (NSCLC). It represents China's first and the world's third approved selective Kirsten rat sarcoma (KRAS) G12C inhibitor. GFH375 is an orally bioavailable small molecule inhibitor targeting KRASG12D (oncogene KRAS mutation). GenFleet Therapeutics has initiated the Phase II portion of a Phase I/II clinical trial in China for advanced solid tumor patients carrying KRASG12D mutations.

GFH925 received Breakthrough Therapy Designation (BTD) for advanced NSCLC and was granted priority review procedures by the National Medical Products Administration. It obtained marketing approval approximately three years after receiving IND approval from the National Medical Products Administration in July 2021, highlighting its competitive advantages over existing treatment options. GFH925 also received BTD from the National Medical Products Administration in May 2023 for third-line treatment of advanced colorectal cancer (CRC) carrying KRASG12C mutations.

GenFleet Therapeutics expects that GFH925 will be eligible for National Reimbursement Drug List negotiations in 2026, as it is China's first and the world's third approved selective KRASG12C inhibitor, and the KRASG12C mutant NSCLC patient population in China is substantial. Currently, GFH925 has over 15 years of remaining patent life, and GenFleet Therapeutics expects to derive commercial returns from GFH925 to support the company's future growth.

However, it should be noted that GenFleet Therapeutics lacks control over its core products, as the company has signed multiple out-licensing agreements with other companies.

For instance, on September 1, 2021, GenFleet Therapeutics entered into a licensing and option agreement with Innovent Biologics (GFH925 Licensing Agreement). Following the agreement, Innovent Biologics became the sponsor of the GFH925X1101 trial in China and has since been fully responsible for the development and commercialization of GFH925 in Greater China. Under this arrangement, Innovent Biologics will continue to pay GenFleet Therapeutics for drug supply, with payment amounts determined based on quantities needed to support trial development.

However, on January 11, 2024, GenFleet Therapeutics and Innovent Biologics entered into a supplemental agreement, whereby both parties agreed to terminate the overseas option under the GFH925 licensing agreement. GenFleet Therapeutics retains exclusive rights to develop, manufacture, and commercialize GFH925 for any indications outside of China.

Additionally, GenFleet Therapeutics has signed other licensing agreements.

On March 31, 2022, GenFleet Therapeutics entered into a licensing agreement with SELLAS. Under the SELLAS licensing agreement, GenFleet Therapeutics granted SELLAS exclusive (even vis-à-vis GenFleet Therapeutics itself), sublicensable, and royalty-bearing rights and licenses to develop, manufacture, and commercialize GFH009 outside Greater China for all therapeutic and diagnostic purposes.

On June 30, 2022, GenFleet Therapeutics entered into a clinical trial collaboration and supply agreement with Merck Healthcare KGaA regarding clinical development of the GFH925/cetuximab combination therapy in a Phase Ib/II clinical trial (GFH925X0201) in the European Union.

On August 24, 2023, GenFleet Therapeutics entered into a collaboration and option agreement with Verastem, whereby GenFleet Therapeutics granted Verastem project-by-project options to obtain exclusive licenses within specified option exercise periods to develop and commercialize three drug candidates, including GFH375, outside Greater China.

From these agreements, it's evident that multiple licensing agreements by GenFleet Therapeutics involve exclusive out-licensing, and the company may heavily rely on third parties in subsequent business development.

Regarding this, GenFleet Therapeutics stated in its prospectus that the company relies on current and future partners to support its business, including assisting with or conducting clinical development and regulatory filings, manufacturing, and/or commercializing certain pipeline products. For example, GenFleet Therapeutics has granted Innovent Biologics exclusive rights to develop, manufacture, and commercialize GFH925, one of GenFleet Therapeutics' core products, in Greater China. GFH925 received NDA approval from the National Medical Products Administration in August 2024. Under this agreement, Innovent Biologics will be fully responsible for GFH925's commercialization in Greater China, while GenFleet Therapeutics is entitled to certain royalties and commercial milestone payments related to GFH925's annual net sales in Greater China, along with other specified upfront and milestone payments. Therefore, GenFleet Therapeutics' future financial condition will partially depend on Innovent Biologics' commercialization efforts.

GenFleet Therapeutics also noted that since the company may have little control over marketing and sales activities beyond contractual terms, actual revenue generated from GFH925's commercialization may be lower than expected, potentially preventing GenFleet Therapeutics from realizing expected benefits from this collaboration. There's no guarantee that GenFleet Therapeutics' partners won't attempt to modify collaboration agreement terms, reducing GenFleet Therapeutics' benefits. If GenFleet Therapeutics cannot realize expected benefits from current and anticipated collaborations, the company's business, financial condition, and operating results could be materially harmed.

**Still in Continuous Losses**

Although GenFleet Therapeutics' GFH925 has begun commercialization, it hasn't yet provided substantial additional revenue. Currently, GenFleet Therapeutics' revenue comes from collaborations with Innovent Biologics regarding core product GFH925, with Verastem regarding core product GFH375, and with SELLAS regarding GFH009.

In terms of revenue, GenFleet Therapeutics generated RMB 73.73 million and RMB 105 million in 2023 and 2024, respectively, but recorded net losses of RMB 508 million and RMB 678 million during the same periods. GenFleet Therapeutics explained that net losses and their fluctuations were primarily related to substantial investments in R&D activities and fair value changes in equity share redemption liabilities due to increased company valuation.

GenFleet Therapeutics stated that developing quality investigational drugs requires substantial long-term financial resource investments, and continuing such investments is a core part of GenFleet Therapeutics' strategy. For the years ended December 31, 2023 and 2024, and the four months ended April 30, 2025, GenFleet Therapeutics incurred R&D costs of RMB 313 million, RMB 332 million, and RMB 69.8 million, respectively.

Regarding shareholders, GenFleet Therapeutics' single largest shareholder group includes co-founder, Chairman, and Executive Director Lu Qiang, co-founder, Executive Director, CEO, and General Manager Lan Jiong, Jianfa Hong Kong, and GenFleet Therapeutics' employee stock ownership plan platform. GenFleet Therapeutics' single largest shareholder group controls approximately 25.23% of GenFleet Therapeutics' total issued share capital.

The prospectus shows that Lu Qiang has extensive experience with renowned pharmaceutical companies. Before founding GenFleet Therapeutics, Lu served as Senior Vice President of CStone Pharmaceuticals (Suzhou) Co., Ltd. until August 2017, which later became a wholly-owned subsidiary of CStone Pharmaceuticals. Prior to joining CStone Pharmaceuticals (Suzhou) Co., Ltd., he served as Chief Scientific Officer and Vice President of Harbin Gloria Pharmaceuticals Co., Ltd. from February 2015 to May 2016, and as Chief Scientific Officer of pharmaceutical company Jiangsu Hengrui Medicine Co., Ltd. from June 2013 to February 2015. From April 2008 to June 2013, he served as Vice President at WuXi AppTec Co., Ltd.

Since GenFleet Therapeutics' incorporation, the company has completed multiple funding rounds, raising a total of approximately RMB 1.421 billion from investors including renowned funds and venture capital firms such as Qiming Venture Partners, Huagai Capital, and Asia Investment Capital.

In 2018, GenFleet Therapeutics completed an angel round with investors including Qiming Venture Partners, totaling RMB 60 million.

In 2019, GenFleet Therapeutics completed Series A and A+ rounds with investors including Ningbo Hongjia, Jianyi Capital, CSPC Pharmaceutical Group, and Haibang Investment, totaling approximately RMB 140 million.

In 2021, GenFleet Therapeutics completed Series B and B+ rounds with investors including CDH Investments, Shenzhen Capital Group, Panlin Capital, and Northern Light Venture Capital, totaling approximately RMB 543 million.

In 2022, GenFleet Therapeutics completed a Series C round with investors including Huagai Capital, Sino Biopharmaceutical, Shanjin Capital, and Huimei Capital, totaling approximately RMB 483 million.

In 2024, GenFleet Therapeutics completed a Series C+ round with investors including Asia Investment Capital, Huajin Capital, Tailong Investment, and Jiangmen Qishun, totaling approximately RMB 195 million.