Hong Kong IPO disclosure precedents · 10 companies, 10 items
The core product has recently obtained regulatory approval but the issuer has not yet commercialized it or generated product sales revenue, with commercialization imminent and further trials or pipeline continuing.
In China, PL-5 has completed its Phase III clinical trials, and received NDA approval from the NMPA in June 2026. We currently expect commercial launch in 2026.
Business · p. 161
In 2024 and 2025, and the six months ended June 30, 2025 and 2026, our R&D expenses amounted to RMB80.7 million, RMB57.2 million, RMB25.7 million and RMB24.4 million.
Financial Information · p. 223
Although we currently have no drugs realized 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 of the Latest Practicable Date, we had self-developed a pipeline comprised of seven small-molecule drug candidates, with a therapeutic focus on hematologic malignancies and autoimmune diseases.
Business · p. 147
In August 2024, we submitted our first NDA to the CDE for the treatment of MF, and received NDA approval in April 2026.
Business · p. 139
We have not generated any revenue from the product sales since inception.
As of the Latest Practicable Date, we were developing a total of eight drug candidates, three of which were in advanced stages, including one candidate that had received NDA approval and was set for commercialization, one candidate for which an NDA had been submitted, and one candidate undergoing Phase 3 clinical trials.
Business · p. 164
our pipeline for assisted reproductive treatments includes (i) JZB30 (Core Product), a rhFSH candidate in lyophilized form, for which we received NDA approval in April 2025, currently being evaluated for the indication expansion for oligospermia
Business · p. 165
With respect to JZB05, it is undergoing Phase 3 clinical trials at over 40 centers across mainland China.
Mufemilast has been approved for commercialization in China for the treatment of moderate to severe plaque Ps.
Business · p. 170
As of the Latest Practicable Date, we had six drug candidates in our product pipeline that had advanced to the clinical stage, including our Core Products, Mufemilast and Hemay022, and our key products, Hemay007, Hemay808, Hemay181 and Hemay5087.
Financial Information · p. 246
Although we currently have not generated any revenue from product sales, we expect to commercialize one or more of our drug candidates over the coming years.
Founded in 2016, we are a biotechnology company focused on and pioneering in the development and commercialization of molecular diagnostic instruments and biochips.
Summary · p. 1
Particularly, our Core Product, AxiLona EL-100, was admitted into the Special Registration Procedures for Innovative Class II Medical Devices (commonly known as Green Path) by the Jiangsu MPA in June 2024 and subsequently obtained the Class II medical device registration certificate from the same authority in April 2025.
Financial Information · p. 224
Although our proprietary clinical test kits are not expected to be commercialized until 2028-2029, we intend to support installed AxiLona EL-100 devices through collaborations with third-party developers.
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 · p. 1
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 · p. 14
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.
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 · p. 151
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 · p. 154
In December 2025, we obtained the NDA approval for AK0901 from the NMPA.
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 · p. 2
to develop and market our Core Products successfully.
Summary · p. 1
We currently have no products approved for commercial sale and were loss-making during the Track Record Period.
We have acquired and developed two Core Products, LV232 and TPN171.
Summary · p. 1
We submitted a NDA to the NMPA in September 2023 and obtained the NDA approval in July 2025.
Business · p. 302
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.
Within our pipeline, we have three Core Products, namely, KBP-3571, an NDA-approved innovative proton pump inhibitor (PPI) for digestive diseases, XZP-3287, an NDA-approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor targeting breast cancer (BC), and XZP-3621, an NDA-approved anaplastic lymphoma kinase (ALK) inhibitor targeting non-small cell lung cancer (NSCLC).
Summary · p. 1
During the Track Record Period, we incurred research and development expenditure (including research and development expenses and capitalized research and development costs recorded as intangible assets) of RMB383.9 million, RMB284.6 million, RMB125.4 million and RMB106.3 million in 2023, 2024, and the six months ended June 30, 2024 and 2025, respectively.
Financial Information · p. 435
As of June 30, 2025, our cash resources amounted to RMB109.8 million, including cash and cash equivalents of RMB8.6 million and financial assets at FVTPL of RMB101.2 million.