第十八A章生物科技公司

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.

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.

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.

Our Core Product, AP301, is a phosphate binder for the treatment of hyperphosphatemia, one of the most prevalent complications of CKD with large unmet medical needs.

As for our other product candidates, only AP301 is in late clinical development stage with NDA submission to NMPA (based on the result of China registrational Phase III trial) expected in June 2026 and to FDA (based on the result of Phase III MRCT in China and the U.S.) expected in the third quarter of 2027.

AP306 has completed the Phase II clinical trial stage in China and initiated a Phase IIb MRCT in May 2026.

Subsequently, we initiated a Phase III clinical trial of SK08 in March 2024.

During the Track Record Period, we incurred research and development expenses of RMB67.6 million in 2024 and RMB61.9 million in 2025, reflecting our ongoing investments in advancing our pipeline.

We expect to complete enrollment in 2027 and submit an NDA to the NMPA in 2028.

GC101 is currently being evaluated in a registrational Phase II clinical trial for advanced melanoma, and we expect to submit a Biologics License Application (BLA) in September 2026.

The trial achieved its primary endpoint in May 2026, with the GC101 treatment group demonstrating a 57% reduction in the risk of disease progression or death compared with the control group.

The research and development costs we incurred for the years ended December 31, 2024 and 2025 amounted to RMB91.0 million and RMB114.9 million, respectively.

We plan to seek marketing approval for MT1013 with the treatment of CKD-SHPT Undergoing Maintenance Hemodialysis. We expect to submit a Pre-NDA in late 2026, and an NDA in early 2027.

Based on the completion of the Phase I clinical trial (MT1013-I-C02) for the treatment of CKD-SHPT in the PRC, and CDE having no objection for the Company to proceed into Phase II clinical trials, the Company’s clinical development demonstrates that for CKD-SHPT, MT1013 has been developed beyond concept stage and is eligible as Core Product.

Our R&D expenses amounted to RMB107.0 million and RMB130.1 million for 2024 and 2025, respectively.

As of the Latest Practicable Date, we had two Core Products and seven additional product candidates in clinical or preclinical development. Our Core Products are LNK01001 and LNK01004.

As of the Latest Practicable Date, our product candidates are still undergoing clinical development and regulatory review, and none has been approved for commercialization.

As of March 31, 2026, we had cash and cash equivalents of RMB144.1 million and our term deposits amounted to RMB50.0 million.

Founded in 2021, we are a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of theranostic radiopharmaceuticals in oncology.

We completed two Phase III clinical trials of ^18^F-LNC1001 in November and December 2025, respectively, and submitted the NDA to the NMPA in December 2025. We expect to receive the NDA approval in 2027.

In 2024 and 2025, our research and development costs amounted to RMB114.7 million and RMB125.9 million, respectively.

HJ891, one of our Core Products, is a KRAS^G12C^ inhibitor intended for the treatment of NSCLC with KRAS^G12C^ mutation.

As of the Latest Practicable Date, the Company had not received the conditional market approval for HJ891 as a monotherapy. The Company expects to apply for conditional marketing approval upon completion of the pivotal Phase IIb clinical trial.

In 2024 and 2025, our research and development expenses amounted to RMB75.0 million and RMB110.2 million, respectively.

Mufemilast has been approved for commercialization in China for the treatment of moderate to severe plaque Ps.

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.

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.

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.

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.

TLL-018, our Core Product, is projected to file for NDA with the NMPA in 2026.

We obtained conditional approvals of azvudine from the NMPA for treating HIV infection and COVID-19 in China in July 2021 and July 2022, respectively.

In 2024 and 2025, our research and development expenses amounted to RMB150.7 million and RMB135.9 million, respectively.

As of December 31, 2025, we had cash and cash equivalents of RMB24.2 million.

LP-168, is a “covalent & non-covalent” dual-mechanism BTK inhibitor under NDA stage.

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.

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.

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.

All product candidates were developed internally by us, and we retain all commercial rights to these pipeline product candidates.

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.

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.

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.

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.

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.

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.

As of the Latest Practicable Date, we had four in-house, clinical-stage innovative drug candidates, including one TCM and three TCEs:

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.

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.

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.

Founded in 2016, we are a biotechnology company focused on and pioneering in the development and commercialization of molecular diagnostic instruments and biochips.

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.

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.

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.

We submitted an NDA to the NMPA and the NDA was accepted in August 2025.

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.

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.

(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.

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.