Incorporated in 2019, we are a clinical-stage gene therapy company dedicated to the in-house development of recombinant adeno-associated virus (“rAAV”) gene therapies.
Summary · 第 1 页
As of the Latest Practicable Date, our product pipeline consisted of six in-house developed rAAV gene therapy candidates, including (i) two Core Products, namely FT-002, a drug candidate being investigated to treat X-linked retinitis pigmentosa (“XLRP”), and FT-003, a drug candidate being investigated to treat neovascular age-related macular degeneration (“nAMD”) and diabetic macular edema (“DME”) through intravitreal injections;
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As of the Latest Practicable Date, we had not obtained marketing approval for any drug candidates, nor had we generated any revenue from product sales.
As of the Latest Practicable Date, we had developed a pipeline of five clinical-stage product candidates, including two Core Products, namely VVN461(HD) and VVN001, and three other product candidates.
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We commenced a Phase III clinical trial in patients with moderate-to-severe DED in China in June 2024 and expect to complete such trial in the first half of 2027.
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Our business and results of operations depend on our ability to successfully develop and manufacture as well as our receipt of regulatory approval for and successful commercialization of our product candidates.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET EXG102-031 SUCCESSFULLY.
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WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET EXG001-307 SUCCESSFULLY.
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During the Track Record Period, we incurred research and development expenses of RMB145.0 million, RMB103.9 million, RMB57.4 million and RMB53.4 million for the years ended December 31, 2024 and 2025 and the six months ended June 30, 2025 and 2026, respectively, in each case representing the largest component of our cost structure during the relevant period.
Our Core Product, TSN1611, is an orally bioavailable KRAS G12D inhibitor, which is currently under phase 2 clinical trials in both the United States and China and is advancing toward a next-phase clinical trial as monotherapy for the treatment of NSCLC.
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As of the Latest Practicable Date, we had not obtained marketing approval for any drug candidates, nor had we generated any revenue from product sales.
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Although we currently have no product approved for commercial sale and have not generated any revenue from product sales, we expect to commercialize one or more of our drug candidates over the coming years as they progress through late-stage development.
We have eight product candidates, including two self-developed Core Products D-2570 and taragarestrant (D-0502).
Summary · 第 1 页
our Core Products tyrosine kinase 2 ("TYK2") inhibitor D-2570 and oral estrogen receptor degrader ("SERD") taragarestrant (D-0502) are both advancing through Phase III registration trials
As of the Latest Practicable Date, we have established a pipeline consisting of nine CAR-T product candidates for the treatment of solid tumors, hematological malignancies and auto-immune diseases, of which four were in clinical development stage.
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As of the Latest Practicable Date, we had launched a registrational Phase III trial in China with IMC002 as a treatment for advanced gastric cancer patients who have received at least two prior lines of systemic treatment.
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We currently expect to complete this registrational clinical trial and submit an NDA application to the NMPA in 2027 with respect to IMC002 as a third-line treatment for gastric cancer/GEJ adenocarcinoma.
Incepted in May 2014, we are a biopharmaceutical company with a pipeline of proprietarily-developed innovative drug candidates centred around the RAS signalling pathways and synthetic lethality mechanism, including (i) one Core Product GH21, an allosteric SHP2 inhibitor, the monotherapy of which is indicated for solid tumour, and the combination therapies of which are indicated for KRAS^G12C^ mutated solid tumours, 3^rd^-generation EGFR-TKI resistant NSCLC, and MAPK-pathway activated solid tumours respectively; and (ii) seven other drug candidates.
Summary · 第 1 页
All of our drug candidates are innovative drugs which are classified as Category I under the Administrative measures for Drug Registration, and are self-developed by us.
Summary · 第 4 页
While we currently have no drugs approved for commercial sales and have not generated any revenue from drug sales, we expect to commercialise one or more of our drug candidates over the coming years as they move towards the final stages of development and if they receive the requisite regulatory approvals.
We primarily engage in the research, development and commercialization of proprietary drugs in the immune-inflammation field.
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As of the Latest Practicable Date, our product pipeline comprised four proprietary drug candidates covering 10 indications, as well as five generic drug candidates targeting multiple chronic inflammatory diseases, all of which are self-developed.
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Our other net income increased significantly from RMB11.2 million in 2024 to RMB36.3 million in 2025, primarily attributable to the RMB30.0 million government grants we received in 2025 as our Pumecitinib gel for atopic dermatitis entered Phase III clinical trials.
Founded in 2007, we are a clinical-stage pharmaceutical company.
Summary · 第 1 页
Our R&D expenses incurred for our two Core Products were approximately RMB11.9 million, RMB26.3 million, RMB5.3 million and RMB14.8 million for the years ended December 31, 2024 and 2025 and the five months ended May 31, 2025 and 2026, respectively, accounting for 72.5%, 69.0%, 51.0% and 77.9% of our total research and development expenses, and 30.7%, 29.9%, 24.2% and 39.5% of our total operating expenses (i.e. selling and distribution expenses, administrative expenses, research and development expenses) during the same periods, respectively.
Business · 第 184 页
None of our Core Products or key product has been approved or in commercial stage, including DHMP, a dissolving microneedle patch for pediatric preoperative sedation, advanced to a Phase II clinical trial, and XJN010, a clinical-stage nasal inhalation drug formulation developed for the on-demand treatment of “Off” episodes in patients with Parkinson’s disease who are already receiving a dopa decarboxylase inhibitor/levodopa regimen.
Our self-discovered Core Product MVR-T3011 is a novel, Phase II herpes simplex virus type 1 (HSV-1)-based oncolytic immunotherapy candidate that pairs potent tumor lysis with expression of both anti-PD-1 antibody and IL-12.
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We initiated a Phase II clinical trial of MVR-T3011 administered intravesically for the treatment of high-risk BCG-unresponsive NMIBC papillary and carcinoma in situ (CIS) cohorts in the U.S., with the first patient dosed in June 2025.
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In 2023, 2024, 2025 and five months ended May 31, 2025 and 2026, our research and development expenses amounted to RMB136.2 million, RMB111.5 million, RMB112.0 million, RMB26.4 million and RMB31.0 million, respectively.
According to the CIC Report, it is currently the only vaccine candidate targeting Staphylococcus aureus globally that is undergoing a Phase III clinical trial.
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As of Latest Practicable Date, we have completed the enrollment of all 6,014 subjects for the Phase III clinical trial.
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Delays in clinical trial timelines, unfavorable clinical data, or a failure to obtain NDA approval for rFSAV or our other vaccine candidates, such as our rHPV, which has received approval for a Phase I clinical trial in Australia, would significantly delay or prevent the generation of revenue from these products, which could adversely affect our business, results of operations, financial condition and prospects.
Our pipeline comprises four clinical-stage drug candidates, including our Core Product EMB-01 (targeting EGFR/cMET) and three TCE-based assets EMB-06 (targeting BCMA/CD3), EMB-07 (targeting ROR1/CD3) and EMB-15 (targeting ALPP(G)/CD3), and four preclinical drug candidates, EM1033 (targeting CD228/CD3), EM1034 (targeting LY6G6D/CD3), EM1039 and EM1042.
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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.
Financial Information · 第 235 页
As of December 31, 2025, our cash and cash equivalents amounted to RMB289.7 million.
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.
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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.
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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.
Summary · 第 3 页
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.
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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.
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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.
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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.
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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.
Business · 第 171 页
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.
Summary · 第 1 页
As of the Latest Practicable Date, our product candidates are still undergoing clinical development and regulatory review, and none has been approved for commercialization.
Summary · 第 14 页
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.
Summary · 第 1 页
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.
Business · 第 163 页
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.
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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.
Business · 第 188 页
In 2024 and 2025, our research and development expenses amounted to RMB75.0 million and RMB110.2 million, respectively.