Hong Kong IPO disclosure precedents · 17 companies, 17 items
The issuer has a core product that has obtained regulatory approval and is being commercialized or generating sales revenue, alongside additional approved products and a pipeline of later-stage candidates.
As of the Latest Practicable Date, we had (i) one Core Product, the Gastric Bypass Stent system (GBS), which is a digestive endoscopic duodenal-jejunal bypass liner (DJBL) device indicated for obesity, and we are expanding the approved indications of the GBS for a lower BMI; (ii) two other products and one digital health management platform that we had obtained registration approval; and (iii) 13 other pipeline products.
Summary · p. 1
During the Track Record Period, we incurred research and development expenses of RMB41.1 million, RMB48.7 million, RMB22.0 million and RMB38.7 million in the year ended December 31, 2024 and 2025 and the six months ended June 30, 2025 and 2026, respectively.
Financial Information · p. 237
Our long-term growth is dependent on the successful development of our pipeline candidates, especially our Key Products, the GBS-SH, the GBS-DM, the DIGB and RIGB.
As of the Latest Practicable Date, we had five approved products and five product candidates under development.
Business · p. 134
iNOwill is positioned primarily for ICU and hospital bedside use, and has been registered as a Class III medical device in China for PH since 2022 and certified as a Class IIb medical device for PH under the EU MDR since 2025.
Business · p. 134
In 2024, 2025 and for the six months ended June 30, 2025 and 2026, our R&D expenses amounted to RMB33.0 million, RMB34.7 million, RMB13.7 million and RMB20.3 million, respectively, accounting for 36.5%, 38.5%, 36.1% and 34.9% of the total operating expenses, respectively, and 72.4%, 54.9%, 61.3% and 34.8% of our total revenue during the same years/periods, respectively.
We have one Core Product, sebaloxavir marboxil tablets, which is an inhibitor targeting the influenza virus polymerase acidic protein (“PA”) endonuclease.
Summary · p. 1
As of the Latest Practicable Date, we have developed a pipeline of six proprietary small molecule drug assets, including our commercialized anti-viral sebaloxavir marboxil tablets, a late clinical stage sebaloxavir marboxil for suspension (in the form of granules-for-suspension) targeting pediatric influenza patients, pyrophosphatase/phosphodiesterase 1 (“ENPP1”) inhibitor ZX-8177 for the treatment of solid tumors, with an IND application submitted to the NMPA in August 2026, subsequent to the Latest Practicable Date, for the treatment of hypophosphatasia (“HPP”), and an IND-enabling stage DNA polymerase inhibitor ZX-12042B for the treatment of human papillomavirus (“HPV”) infections.
Summary · p. 1
we have sufficient working capital to cover at least 125% of our costs, including research and development costs, selling expenses and administrative and other operating expenses for at least the next 12 months from the date of this document.
As of the Latest Practicable Date, we had commercialized four vaccine products covering two disease areas in the PRC, namely rabies and influenza.
Business · p. 140
Out of these four vaccine candidates that have received clinical trial approval or are in clinical stages, we expect to launch at least two from 2026 to 2028.
Business · p. 140
Our R&D expenses increased during the Track Record Period, amounting to RMB53.3 million, RMB81.0 million and RMB121.7 million in 2023, 2024 and 2025, representing 16.4%, 99.6% and 23.1% of total revenue, respectively.
We received the Class III medical device registration certificate from the NMPA in May 2022 and were still in the early stage of commercializing our TH-S1.
Business · p. 164
Currently, we are still in the early stage of commercialization and we are in the process of promoting market acceptance of our products by the physician and hospital communities.
Financial Information · p. 235
In 2024 and 2025, our research and development expenses amounted to RMB50.8 million and RMB56.9 million, respectively, representing 40.4% and 39.7% of our total operating expenses (being research and development expenses, administrative expenses and selling and distribution expenses), respectively.
As of the Latest Practicable Date, we had successfully commercialized our RC120 Puncture Surgical Robot, but was still at an early stage of the commercialization process.
Summary · p. 6
In 2023, 2024 and the six months ended June 30, 2024 and 2025, we incurred R&D costs of RMB23.9 million, RMB19.0 million, RMB9.2 million and RMB9.1 million, respectively.
Financial Information · p. 297
Whether our pipeline products can demonstrate favorable safety and efficacy clinical evaluation results, whether we can obtain the requisite regulatory approvals for our pipeline products in time, and whether we can build a sales and marketing network to commercialize our products successfully are crucial for our business and results of operations.
As of the Latest Practicable Date, our pipeline comprised of one commercial-stage, four clinical-stage and seven pre-IND stage assets, representing one of the most comprehensive and advanced SL portfolios in China and worldwide, according to Frost & Sullivan.
Business · p. 150
(i) senaparib (IMP4297), our Core Product, a PARP1/2 inhibitor approved in China as 1L maintenance therapy for OC “all-comers,” with a compelling clinical profile, (ii) IMP1734, a highly potent, next-generation PARP1 selective inhibitor, (iii) IMP9064, an ATR selective inhibitor, (iv) IMP1707, a CNS penetrant, PARP1 selective inhibitor, (v) IMP7068, the most clinically advanced WEE1 inhibitor in China, (vi) seven preclinical assets targeting most of the key SL targets such as PKMYT1/WEE1, DHX9, ATM, USP1 and CHK1/2, and emerging modalities such as novel ADC and degrader candidates.
Business · p. 150
As of March 31, 2026, being the latest practicable date for determining our indebtedness, we had cash and cash equivalents and financial assets at fair value through profit or loss of RMB284.4 million.
IHepcomf (艾馨甘), targeting liver cancer and approved by NMPA as a Class III medical device in January 2025, and IUrisure (艾光樂), targeting urothelial cancer and approved by NMPA as a Class III medical device in October 2025, constitute our Core Products for purposes of this document.
Business · p. 129
Our research and development expenses amounted to RMB15.0 million and RMB21.3 million for the years ended December 31, 2024 and 2025, respectively, accounting for 207.2% and 138.1% of our total revenue for the respective periods.
Financial Information · p. 227
Our pipeline products are technologically compatible with our existing products so that we can leverage our existing proprietary technologies to improve return of research and development expenditure.
It has successfully completed clinical trials and submitted a Class III medical device registration application to the NMPA in May 2025.
Financial Information · p. 235
As of the Latest Practicable Date, as stipulated in the June NMPA Communication and December NMPA Communication, the NMPA has no objections toward the registrational approval of AI AutoVision^®^.
WE MAY NOT BE ABLE TO SUCCESSFULLY MARKET OUR CORE PRODUCTS IN OVERSEAS MARKETS AS PLANNED, OR SUCCESSFULLY DEVELOP OR MARKET THE EXPANSION OF SURGICAL APPLICATIONS (E.G., UROLOGIC, GYNECOLOGIC, GENERAL AND THORACIC TELESURGERIES, AS WELL AS PEDIATRIC, CARDIAC AND OTORHINOLARYNGOLOGY (ENT), HEAD AND NECK SURGERIES) OF OUR CORE PRODUCTS AND OTHER PRODUCT CANDIDATES IN CHINA OR IN OVERSEAS MARKETS (E.G., JAPAN AND KOREA).
Summary · p. 2
We received the initial registration approval from the NMPA for our Edge Multi-Port Endoscopic Surgical Robot, Edge Single-Port Endoscopic Surgical Robot and Edge Bronchoscope Robot in December 2022, November 2023 and January 2025, respectively.
Summary · p. 2
As of the Latest Practicable Date, we had 453 issued patents and 213 patent applications in China.
As of the Latest Practicable Date, we had established a product pipeline consisting of eight product candidates with five under clinical development, including two Core Products — GFH925 and GFH375.
Summary · p. 1
Having received the NDA approval from the NMPA as a Class 1 new drug in August 2024 for the second or later-line treatment of NSCLC harboring the KRAS G12C mutation, it is China's first and globally the third approved selective inhibitor of KRAS G12C.
Summary · p. 4
We are conducting a Phase I/II clinical trial of GFH375 in China to evaluate its safety and efficacy in treating advanced solid tumors with the KRAS G12D mutation and a Phase II clinical trial of GFH375 in China to evaluate its safety and efficacy in treating PDAC with the KRAS G12D mutation.
We successfully obtained regulatory approval in January 2025 for Efsubaglutide Alfa for the treatment of type 2 diabetes (T2D) in China.
Summary · p. 1
Both therapies were approved in January 2025. We commercially launched Efsubaglutide Alfa for the treatment of T2D in China in February 2025.
Business · p. 296
We have commercialized Efsubaglutide Alfa for the treatment of T2D both as a monotherapy and in combination with metformin in China and built a pipeline to address the significantly unmet clinical needs in metabolic diseases, including (i) Efsubaglutide Alfa for the treatment of obesity and being overweight, for which we completed a Phase IIa clinical trial in China in November 2024, (ii) Efsubaglutide Alfa for the treatment of MASH, for which we have obtained IND approvals from the FDA and the NMPA to commence Phase IIa clinical trials, and plan to initiate a multi-center Phase IIa clinical trial for MASH in the U.S. and China, and (iii) five pre-clinical stage or IND-enabling drug candidates.
As of the Latest Practicable Date, we had (i) two Core Products, the quadrivalent subunit influenza vaccine, which was approved by the National Medical Products Administration of the PRC (NMPA) for individuals aged three years and above under the brand name Huierkangxin (慧爾康欣) in May 2023, and lyophilized (freeze-dried) human rabies vaccine candidate, which is developed using human diploid cells with robust safety profile; and (ii) 11 other vaccine candidates covering various disease areas with considerable needs for vaccination.
Summary · p. 1
As of the Latest Practicable Date, we had two Core Products, namely, our quadrivalent subunit influenza vaccine and lyophilized human rabies vaccine candidate, and 11 other product candidates, including (i) one product candidate in the NDA stage, namely our trivalent subunit influenza vaccine; and (ii) 10 product candidates in various stages of clinical and preclinical development.
Business · p. 245
We may not be able to ultimately develop and market any of our vaccine candidates.
GASTROClear™, our Core Product, is a blood-based miRNA detection panel consisting of 12 miRNA biomarkers for gastric cancer screening.
Summary · p. 1
In China, we completed a prospective clinical trial with seven medical institutions in November 2023 and submitted a registration application to the NMPA in December 2023.
Business · p. 354
As confirmed by our Directors, our PRC Legal Advisor is of the view that as of the Latest Practicable Date and to the best of their knowledge, there were no material impediments or delays expected in obtaining the registrational approval of GASTROClear™ as an IVD product in the PRC in the first half of 2025, nor in launching GASTROClear™ as an IVD product in the PRC in the first half of 2025.
Our core product, the Brain Function Information Management Platform Software System (the “System” or the “Core Product”), has been commercialized for eight indications from four major types of cognitive impairment and is under development for several other cognitive impairment indications as of the Latest Practicable Date.
Summary · p. 1
In addition to the BCAT and the SAS, for which we had obtained regulatory approval, we are also under various stages of preclinical and clinical development for the following products and product candidates.
Business · p. 310
In 2021, 2022, 2023, and the six months ended June 30, 2023 and 2024, our research and development expenses amounted to RMB32.8 million, RMB67.6 million, RMB90.7 million, RMB34.4 million and RMB64.2 million, respectively.
As of the Latest Practicable Date, we had one commercialized product and 19 other pipeline product candidates, with Utidelone Injection being our single Core Product.
Summary · p. 1
Utidelone Injection received approval from the NMPA in 2021 for its lead indication, the treatment of relapsed or metastatic breast cancer patients who have received at least one anthracycline- or taxane-containing chemotherapy regimen in combination with capecitabine.
Summary · p. 1
Our R&D expenses amounted to RMB82.7 million, RMB126.5 million, RMB58.2 million and RMB43.8 million for the years ended December 31, 2022 and 2023 and the five months ended May 31, 2023 and 2024, respectively.