Hong Kong IPO disclosure precedents · 56 companies, 56 items
The issuer has no approved products or product sales revenue, and its core products remain in clinical trial stages with explicit risk that they may not be successfully developed or commercialized.
Our business and results of operations depend on our ability to successfully advance our drug development programs, demonstrate favorable safety and efficacy clinical trial results, obtain the requisite regulatory approvals, secure adequate manufacturing capacity, and commercialize our products in targeted markets as planned.
Financial Information · p. 226
In 2024, 2025 and the three months ended March 31, 2025 and 2026, our research and development expenses amounted to RMB127.3 million, RMB150.8 million, RMB24.8 million and RMB37.1 million, respectively.
Financial Information · p. 226
TLL-018, our Core Product, is projected to file for NDA with the NMPA in 2026.
LP-168, is a “covalent & non-covalent” dual-mechanism BTK inhibitor under NDA stage.
Summary · p. 4
As of the Latest Practicable Date, our pipeline comprised of six in-house developed drug candidates, including three clinical-stage drug assets, namely LP-168, LP-108 and LP-118.
Financial Information · p. 228
Although we currently have no drug candidate approved for commercial sale and have not generated any revenue from drug sales, we expect to commercialize one or more of our drug candidates over the coming years as they progress through late-stage development.
Currently, the seasonal AR indication is undergoing Phase III clinical trial in China and we plan to submit BLA to the NMPA in or before the third quarter of 2026.
Business · p. 149
We are currently conducting two Phase II clinical trials in China to evaluate the efficacy of LP-005 in the treatment of PNH and a Phase II clinical trial for complement-mediated kidney diseases in China.
Business · p. 149
All product candidates were developed internally by us, and we retain all commercial rights to these pipeline product candidates.
We are currently enrolling patients for ES102’s phase 2 clinical trial in combination with toripalimab in patients with advanced NSCLC in China to further explore ES102’s potential in combination therapies. As of the Latest Practicable Date, 22 patients had been enrolled.
Summary · p. 14
Our business will depend on the successful development, regulatory approval and commercialization of our drug candidates for the treatment of patients with our targeted indications, and other new drug candidates that we may identify and develop.
Financial Information · p. 241
As of March 31, 2026, being the latest practicable date for determining our indebtedness, we had cash and cash equivalents of RMB186.1 million.
We are a clinical-stage biotech company focused on the development of TCE through an antibody discovery and development engine.
Business · p. 155
As of the Latest Practicable Date, we had four in-house, clinical-stage innovative drug candidates, including one TCM and three TCEs:
Business · p. 140
The research and development costs we incurred for the years ended December 31, 2024 and 2025 amounted to RMB53.4 million and RMB46.6 million, respectively.
As of the Latest Practicable Date, we had six major innovative drug candidates.
Financial Information · p. 237
For the years ended December 31, 2023, 2024 and 2025, our research and development expenses amounted to RMB248.6 million, RMB297.5 million and RMB304.9 million, respectively, accounting for 21.4%, 23.7% and 25.5% of our total revenue for the same periods.
Financial Information · p. 239
However, there can be no assurance that this strategy will be successfully implemented or that it will yield the results we expect: our innovative drug candidates may not obtain regulatory approval or achieve commercial success, our generics revenue may come under pressure from increasing competition, shifting market demand and changes of pricing, among others, and we may not be able to build the additional capabilities required to complete this transition in a timely or cost-effective manner.
Although all of our drug candidates currently have not been approved for commercialization, and we have not generated any revenue from sales of our drug candidates, we expect to commercialize one or more of our drug candidates in the near future.
Financial Information · p. 284
We submitted an NDA to the NMPA and the NDA was accepted in August 2025.
Business · p. 200
Whether we are able to achieve one or more of these in a timely manner may affect our business and our ability to generate sufficient revenue and cash flows to sustain our operations.
There is no assurance that we will ultimately be able to develop and market our Core Product successfully.
Summary · p. 1
We received the IND approval for the Phase IIa trial of ECC4703 and ECC0509 for the treatment of MASH as monotherapy and in combination therapy, in October 2025.
Summary · p. 4
Our business and results of operations depend on our ability to successfully advance our drug development programs, demonstrate favorable safety and efficacy clinical trial results, obtain the requisite regulatory approvals, secure adequate manufacturing capacity, and commercialize our products in targeted markets as planned.
It is currently in a Phase III clinical trial (HORIZON-1) in China for obesity, and has demonstrated favorable tolerability and competitive weight-loss efficacy for obesity in its Phase II trial.
Summary · p. 1
As of the Latest Practicable Date, we had cultivated a diverse pipeline of eight drug candidates, with four drug candidates advanced into clinical development, including zovaglutide, ZT006, ZT003 and ZT001.
Financial Information · p. 191
Specifically, zovaglutide is expected to complete its Phase III clinical trial and submit a BLA for obesity treatment to the NMPA in 2028.
As of the Latest Practicable Date, our pipeline included (i) ifebemtinib, a registration-stage FAK inhibitor with Breakthrough Therapy Designations from the NMPA across three indications and Fast Track Designation from the FDA for one indication, (ii) IN10028, a second-generation FAK inhibitor, (iii) three ADC candidates: OMTX705, IN30758, and IN30778, and (iv) IN20518, a PD-1 and GDF15 dual-targeting bispecific antibody.
Business · p. 149
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from product sales before the commercialization of one or more of our product candidates.
Business · p. 187
We adopt a “backbone therapy” strategy centered on ifebemtinib, positioning it as a cornerstone of combination therapy and a platform to empower various treatment regimens.
As of the Latest Practicable Date, we had built a competitive pipeline portfolio consisting of 4 commercialized products and 10 drug candidates (1 in NDA stage, 8 in clinical stage and 1 in preclinical stage).
Financial Information · p. 262
While we have generated revenue from the sales of several commercialized products, our Core Product 9MW2821 and other pipeline products have not been approved for commercial sale.
Financial Information · p. 262
The R&D costs we incurred in 2024 and 2025 amounted to RMB782.9 million and RMB977.0 million, respectively.
BS001 is the world's first HSV-2-based oncolytic virus candidate to reach clinical stage and advance into a Phase III pivotal trial, underscoring its potential to become the first approved HSV-2-based therapy globally.
Summary · p. 4
We commenced the Phase III trial of BS001 monotherapy in patients with unresectable or metastatic melanoma in March 2023 in China.
Business · p. 181
As of March 5, 2026, a total of 230 patients had been enrolled. The interim data readouts for this trial are expected in the third quarter of 2026.
Our leading assets include (i) SRSD107, our Core Product and a competitive FXI siRNA under a global co-development and co-commercialization partnership with CRISPR Therapeutics, currently in a Phase 2 multi-regional trial for VTE in Europe and China, and another Phase 2 trial for CVD in China, (ii) SRSD216, a differentiated Lp(a)-targeting siRNA in Phase 2 trials in both China and the U.S., and (iii) SRSD384, an INHBE-targeting candidate for obesity advancing toward IND submission.
Business · p. 151
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET SRSD107 SUCCESSFULLY.
Currently undergoing Phase 2b/3 clinical trials in both the U.S. and China for the treatment of gout, ABP-671 is a Class 1 innovative URAT1 inhibitor being developed as a first-line ULT.
Summary · p. 4
As such, ABP-671 is eligible as Core Product under Chapter 18A of the Listing Rules and Chapter 2.3 of the Listing Guide.
Business · p. 178
In 2024 and 2025, our research and development expenses were RMB338.1 million and RMB179.7 million, respectively, accounting for 96.8% and 92.4% of our total operation expenses (representing research and development expenses and administrative expenses) for the same periods, respectively.
As of the Latest Practicable Date, we have established a product pipeline comprising (i) one commercialized product, Sangbo'en, for type 2 diabetes, (ii) three Core Products, including WH007 for polycystic ovary syndrome ("PCOS"), WH006 for obesity, and WH002 for neoadjuvant treatment for breast cancer, and (iii) five other drug candidates.
Summary · p. 1
In December 2025, we obtained the IND approval from the NMPA to conduct Phase II clinical trial of WH007.
Summary · p. 12
WH002 has completed Phase I clinical trial in December 2023 and completed Phase II clinical trial in November 2025.
We have one Core Product, RBD4059 (FXI-targeting siRNA), targeting thrombotic diseases, among a pipeline of seven in-house discovered drug assets in clinical trials for seven indications across cardiovascular, metabolic, renal and liver diseases, including four in phase 2 clinical trials.
Summary · p. 1
During the Track Record Period, the aggregate research and development expenses we incurred for the Core Product amounted to RMB128.1 million, representing 17.7% of our total research and development expenses during the same period, which constituted the largest proportion among all our pipeline candidates and demonstrates our primary engagement in R&D for the purpose of developing the Core Product in accordance with Chapter 2.3 of the Guide for New Listing Applicants.
Financial Information · p. 424
RBD4059, our Core Product, is the first clinical-stage siRNA drug that targets thrombotic disease, showcasing the capability of our proprietary RiboGalSTAR^TM^ delivery platform to create first-in-class therapeutics.
As of the Latest Practicable Date, we have generated more than 20 clinical or IND-enabling stage assets using Pharma.AI, our proprietary generative AI platform, with three of these assets out-licensed to international pharmaceutical and healthcare companies with the maximum total contract value of up to US$2.1 billion, including a total upfront payment of up to US$110.0 million and milestone payment of up to US$1.9 billion and one Phase II asset under self development, which has progressed to a comparatively more advanced stage among peer companies.
Summary · p. 1
As of the Latest Practicable Date, none of our drug candidates had been commercialized.
Business · p. 256
Our future success will substantially depend on the success of our pipeline drug development, which includes research and development, and subsequent commercialization upon receipt of marketing authorization of our in-house developed pipeline drug candidates, as well as the out-licensing of certain pipeline drug candidates in which we retain exclusive ownership of relevant intellectual property rights.
Since 2016, we have developed a product pipeline comprising of one Core Product and nine other pipeline candidates, which are (i) three clinical stage drug candidates focused on oncology, including our Core Product HX009 and Key Products HX301 and HX044; and (ii) seven preclinical stage drug candidates including antibody drug conjugate, bispecific antibody and monoclonal antibody for both autoimmune and oncology market.
Summary · p. 1
Our product candidates have not been approved for commercialization and no revenue has been generated from sales of such product candidates.
Financial Information · p. 469
Our research and development costs amounted to RMB46.7 million, RMB74.7 million, RMB50.5 million and RMB56.2 million for the years ended December 31, 2023 and 2024 and the eight months ended August 31, 2024 and 2025, respectively.
As of the Latest Practicable Date, our pipeline comprised two Core Products: (i) Pro-101-1 for the treatment of deep second-degree thermal burns, which has completed the statistical data analysis for Phase IIb clinical trial, and for the treatment of superficial second-degree burns, which has reached last-patient-out but no statistical data was yet available; and (ii) Pro-101-2 for the treatment of diabetic foot ulcers (“DFUs”), which is currently in Phase II clinical trial.
As of the Latest Practicable Date, we had researched and developed three pipelines consisting of ten candidates covering 14 indications, comprising two Core Products, namely Pro-101-1 and Pro-101-2, currently undergoing the Phase IIb and II clinical trials for two indications in China, respectively.
Business · p. 283
We plan to launch the Pro-101-1 product in China in 2027.
This innovative drug pipeline is led by iza-bren, an EGFR × HER3 bispecific ADC currently in pivotal registration clinical trials, which we believe has the potential to become a backbone pan-tumor treatment.
Business · p. 271
As of the Latest Practicable Date, our innovative drug pipeline featured 17 clinical-stage drug candidates, six of which were undergoing trials in the United States as of the same date.
Business · p. 271
We have not generated any revenue from the sales of drugs in our biologics portfolio. Our business and results of operations depend on our ability to continuously advance preclinical and clinical development of, and obtain the requisite regulatory approvals for, our drug candidates in biologics portfolio.