There is no assurance that we will ultimately be able to develop and market our Core Product successfully.
Summary · 第 1 页
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 · 第 4 页
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 · 第 1 页
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 · 第 191 页
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 · 第 149 页
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 · 第 187 页
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 · 第 262 页
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 · 第 262 页
The R&D costs we incurred in 2024 and 2025 amounted to RMB782.9 million and RMB977.0 million, respectively.
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 · 第 129 页
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 · 第 227 页
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.
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 · 第 4 页
We commenced the Phase III trial of BS001 monotherapy in patients with unresectable or metastatic melanoma in March 2023 in China.
Business · 第 181 页
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 · 第 151 页
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET SRSD107 SUCCESSFULLY.
As of the Latest Practicable Date, we had (i) one Core Product, biased GLP-1 injectable ecnoglutide (XW003), indicated for overweight/obesity, T2DM, moderate-to-severe obesity, adolescent obesity, MASH, OSA and other obesity related comorbidities; and (ii) seven other pipeline products.
Summary · 第 1 页
In January 2026 and March 2026, we received the approval for injectable ecnoglutide (XW003) for T2DM and overweight/obesity treatments from the NMPA, respectively.
Summary · 第 14 页
Our injectable ecnoglutide (XW003) received the approvals for T2DM and overweight/obesity treatments in Chinese Mainland in January 2026 and March 2026, respectively, but we have not generated any revenue from product sales.
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 · 第 4 页
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 · 第 178 页
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.
It has successfully completed clinical trials and submitted a Class III medical device registration application to the NMPA in May 2025.
Financial Information · 第 235 页
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^®^.
Our pipeline features an RSV portfolio consisting of ziresovir, the first therapeutic drug specifically targeting RSV infection at NDA stage and AK0610, a phase II stage mAb for the prevention of RSV infection, an IPF drug, AK3280 at post phase II PoC clinical stage, and an ADHD drug, AK0901 at NDA stage.
Business · 第 151 页
Following the completion of its phase III clinical trial and supplementary phase III clinical trial in China, we have submitted the NDA application to the NMPA in August 2025, which is currently under technical review.
Business · 第 154 页
In December 2025, we obtained the NDA approval for AK0901 from the NMPA.
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 · 第 1 页
In December 2025, we obtained the IND approval from the NMPA to conduct Phase II clinical trial of WH007.
Summary · 第 12 页
WH002 has completed Phase I clinical trial in December 2023 and completed Phase II clinical trial in November 2025.
苏州瑞博生物技术股份有限公司Suzhou Ribo Life Science Co., Ltd.06938.HK
核心产品RBD4059处II期临床并为主要研发对象
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 · 第 1 页
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 · 第 424 页
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.
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 · 第 2 页
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 · 第 2 页
As of the Latest Practicable Date, we had 453 issued patents and 213 patent applications in China.
英矽智能INSILICO MEDICINE InSilico Medicine Cayman TopCo03696.HK
核心产品ISM001-055处于II期临床，尚无产品商业化
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 · 第 1 页
As of the Latest Practicable Date, none of our drug candidates had been commercialized.
Business · 第 256 页
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 · 第 1 页
Our product candidates have not been approved for commercialization and no revenue has been generated from sales of such product candidates.
Financial Information · 第 469 页
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 · 第 283 页
We plan to launch the Pro-101-1 product in China in 2027.
上海宝济药业股份有限公司Shanghai Bao Pharmaceuticals Co., Ltd.02659.HK
核心产品研发阶段与无商业化产品
As of the Latest Practicable Date, our Core Product, SJ02 has received NDA approval from the NMPA in August 2025 and two of our drug candidates have progressed into advanced trial- or NDA registration-stage in China, namely our Core Products KJ103 and KJ017.
Summary · 第 2 页
to develop and market our Core Products successfully.
Summary · 第 1 页
We currently have no products approved for commercial sale and were loss-making during the Track Record Period.
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 · 第 271 页
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 · 第 271 页
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.
We have acquired and developed two Core Products, LV232 and TPN171.
Summary · 第 1 页
We submitted a NDA to the NMPA in September 2023 and obtained the NDA approval in July 2025.
Business · 第 302 页
In 2023 and 2024 and the first four months of 2024 and 2025, our research and development expenses amounted to RMB131.3 million, RMB134.9 million, RMB51.7 million and RMB63.9 million, respectively.