第十八A章生物科技公司

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).

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.

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.

As of the Latest Practicable Date, we had established a product pipeline consisting of eight product candidates with five under clinical development, including two Core Products — GFH925 and GFH375.

Having received the NDA approval from the NMPA as a Class 1 new drug in August 2024 for the second or later-line treatment of NSCLC harboring the KRAS G12C mutation, it is China's first and globally the third approved selective inhibitor of KRAS G12C.

We are conducting a Phase I/II clinical trial of GFH375 in China to evaluate its safety and efficacy in treating advanced solid tumors with the KRAS G12D mutation and a Phase II clinical trial of GFH375 in China to evaluate its safety and efficacy in treating PDAC with the KRAS G12D mutation.

We successfully obtained regulatory approval in January 2025 for Efsubaglutide Alfa for the treatment of type 2 diabetes (T2D) in China.

Both therapies were approved in January 2025. We commercially launched Efsubaglutide Alfa for the treatment of T2D in China in February 2025.

We have commercialized Efsubaglutide Alfa for the treatment of T2D both as a monotherapy and in combination with metformin in China and built a pipeline to address the significantly unmet clinical needs in metabolic diseases, including (i) Efsubaglutide Alfa for the treatment of obesity and being overweight, for which we completed a Phase IIa clinical trial in China in November 2024, (ii) Efsubaglutide Alfa for the treatment of MASH, for which we have obtained IND approvals from the FDA and the NMPA to commence Phase IIa clinical trials, and plan to initiate a multi-center Phase IIa clinical trial for MASH in the U.S. and China, and (iii) five pre-clinical stage or IND-enabling drug candidates.

As of the Latest Practicable Date, we had (i) two Core Products, the quadrivalent subunit influenza vaccine, which was approved by the National Medical Products Administration of the PRC (NMPA) for individuals aged three years and above under the brand name Huierkangxin (慧爾康欣) in May 2023, and lyophilized (freeze-dried) human rabies vaccine candidate, which is developed using human diploid cells with robust safety profile; and (ii) 11 other vaccine candidates covering various disease areas with considerable needs for vaccination.

As of the Latest Practicable Date, we had two Core Products, namely, our quadrivalent subunit influenza vaccine and lyophilized human rabies vaccine candidate, and 11 other product candidates, including (i) one product candidate in the NDA stage, namely our trivalent subunit influenza vaccine; and (ii) 10 product candidates in various stages of clinical and preclinical development.

We may not be able to ultimately develop and market any of our vaccine candidates.

Founded in 2012, we are a clinical-stage biotechnology company focused on the discovery, development, and commercialization of new therapies in oncology, autoimmune, and other severe diseases.

We currently have no products approved for commercial sale and have not generated any revenue from product sales.

In 2023, 2024 and the three months ended March 31, 2024 and 2025, we incurred research and development expenses of RMB230.9 million, RMB185.7 million, RMB43.3 million and RMB57.8 million, respectively.

We had a pipeline of eight drug candidates as of the Latest Practicable Date, comprising four clinical-stage drug candidates and four pre-clinical stage drug candidates.

We expect to complete phase 3 MRCT for CBT-001 in the United States and China in June 2026.

Our R&D expenses were US$15.3 million, US$27.5 million and US$37.9 million for the years ended 31 December 2022, 2023 and 2024, respectively.

We are a clinical demand-oriented, registrational clinical stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases.

As of the Latest Practicable Date, it was undergoing two pivotal/registrational clinical trials for the treatment of cholangiocarcinoma (“CCA”) that has progressed following prior FGFR inhibitor therapy, one being conducted in China and the other as a multi-regional clinical trial (“MRCT”) involving the U.S.

Our Directors are of the opinion that, taking into account (i) the financial resources available to our Company, including cash and cash equivalents of RMB569.5 million as of December 31, 2024, financial assets at FVTPL of RMB3.0 million as of December 31, 2024, available financing facilities and the estimated net proceeds from the Global Offering, (ii) the expected commercialization timetable of our Core Product, and (iii) our cash burn rate, we will have sufficient working capital to cover at least 125% of our costs, including research and development costs and administrative expenses, for at least the next twelve months from the date of this prospectus.

The new drug application (“NDA”) for PB-119 in China for T2DM was accepted by the NMPA in September 2023, marking a key milestone for its upcoming commercialization.

We expect to receive the NDA approval and commercially launch PB-119 for the treatment of T2DM in China in 2025.

As of the Latest Practicable Date, we had developed a diverse pipeline of six product candidates, among which three were undergoing clinical trials and one had received IND clearance.

GASTROClear™, our Core Product, is a blood-based miRNA detection panel consisting of 12 miRNA biomarkers for gastric cancer screening.

In China, we completed a prospective clinical trial with seven medical institutions in November 2023 and submitted a registration application to the NMPA in December 2023.

As confirmed by our Directors, our PRC Legal Advisor is of the view that as of the Latest Practicable Date and to the best of their knowledge, there were no material impediments or delays expected in obtaining the registrational approval of GASTROClear™ as an IVD product in the PRC in the first half of 2025, nor in launching GASTROClear™ as an IVD product in the PRC in the first half of 2025.

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.

DB-1303/BNT323 is a late clinical-stage HER2 ADC candidate with two ongoing registrational trials (one global trial and one in China) and one potential global registrational study, with the first indication (HER2-expressing EC) projected to file for accelerated approval with the FDA as early as 2025.

In 2023 and 2024, our costs and expenses in relation to R&D activities were RMB986.7 million and RMB1,993.3 million, respectively.

WE MAY NOT BE ABLE TO DEVELOP AND/OR MARKET OUR CORE PRODUCT SUCCESSFULLY.

We made the BLA filing with the NMPA on January 18, 2024 for our Core Product for the treatment of PGHD, which was subsequently accepted by the NMPA on March 7, 2024.

Our Directors are of the opinion that, taking into account the financial resources available to our Group, including cash and cash equivalents and the estimated net proceeds from the Listing, we have sufficient working capital to cover at least 125% of our costs, including R&D costs and administrative expenses for at least the next 12 months from the expected date of this document.

Our core product, the Brain Function Information Management Platform Software System (the “System” or the “Core Product”), has been commercialized for eight indications from four major types of cognitive impairment and is under development for several other cognitive impairment indications as of the Latest Practicable Date.

In addition to the BCAT and the SAS, for which we had obtained regulatory approval, we are also under various stages of preclinical and clinical development for the following products and product candidates.

In 2021, 2022, 2023, and the six months ended June 30, 2023 and 2024, our research and development expenses amounted to RMB32.8 million, RMB67.6 million, RMB90.7 million, RMB34.4 million and RMB64.2 million, respectively.

As of the Latest Practicable Date, we had one commercialized product and 19 other pipeline product candidates, with Utidelone Injection being our single Core Product.

Utidelone Injection received approval from the NMPA in 2021 for its lead indication, the treatment of relapsed or metastatic breast cancer patients who have received at least one anthracycline- or taxane-containing chemotherapy regimen in combination with capecitabine.

Our R&D expenses amounted to RMB82.7 million, RMB126.5 million, RMB58.2 million and RMB43.8 million for the years ended December 31, 2022 and 2023 and the five months ended May 31, 2023 and 2024, respectively.

We are currently conducting a pivotal Phase II clinical trial of TY-9591 monotherapy as first-line treatment of brain metastases from non-small cell lung cancer (“NSCLC”) with epidermal growth factor receptor (“EGFR”) mutations in China, as well as a registrational Phase III clinical trial of TY-9591 monotherapy as first-line treatment in locally advanced (stage IIIb to IV) or metastatic NSCLC with EGFR L858R mutation in China.

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.

In 2022 and 2023 and the three months ended March 31, 2023 and 2024, our research and development costs amounted to RMB229.8 million, RMB249.3 million, RMB55.0 million and RMB64.7 million, respectively.

Founded in 2018, we are a clinical stage biopharmaceutical company that focuses on the discovery, development and commercialization of biologics for the treatment of cancers and autoimmune diseases.

Although all of our product candidates currently have not been approved for commercialization, and we have not generated any revenue from sales of our product candidates, we expect to commercialize one or more of our product candidates over the coming years.

Our Directors are of the opinion that, taking into account the financial resources available to our Group, including cash and cash equivalents and the estimated net proceeds from the Global Offering, we have available sufficient working capital to cover at least 125% of the Group’s costs, including general, administrative and operating costs (including any production costs), research and development costs for at least the next 12 months from the date of this prospectus.

Founded in 2015, we are a clinical-stage biotech company exclusively focused on biologic therapies for autoimmune and allergic diseases.

In 2021, 2022 and the nine months ended September 30, 2022 and 2023, our research and development expenses amounted to RMB151.9 million, RMB257.2 million, RMB189.7 million and RMB263.3 million, respectively.

As of January 31, 2024, the latest practicable date for determining our indebtedness, we had cash and cash equivalents of RMB141.9 million and financial assets at FVTPL, comprising of short-maturity financial products we purchased, of RMB210.8 million.

Our Core Product, HTD1801 (berberine ursodeoxycholate), a new molecular entity, is a gut-liver anti-inflammatory metabolic modulator which targets multiple pathways pivotal to metabolic regulation, including those associated with metabolic and digestive diseases.

WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET OUR CORE PRODUCT.

In November 2023, we initiated the two Phase III clinical trials (i.e. one with HTD1801 as a standalone treatment and one with HTD1801 as an add-on therapy with metformin) for the T2DM indication of our self-developed HTD1801 in China.

We have designed and developed a pipeline of seven clinical-stage drug candidates, including our Core Product M701, a recombinant BsAb for which we are currently conducting a Phase II clinical trial in treating malignant ascites (MA) and a Phase Ib/II clinical trial in treating malignant pleural effusion (MPE), and six other drug candidates at various clinical stages.

With respect to M701, our Core Product, we are currently conducting a Phase II clinical trial in treating MA.

We also expect to commence a pivotal/Phase III clinical trial of M701 in treating MA in the first quarter of 2024 and the expected BLA submission time will be in the first quarter of 2025.

We have developed our Core Product, IMM01, an innovative clinical-stage CD47-targeted molecule.

We have not generated any revenue from the sales of our drug products since our inception.

As of the Latest Practicable Date, we had not received any material concerns, objections or negative statements raised by the NMPA, the FDA or other relevant authorities that we are not able to address in a timely manner.

We have two ADC drugs as our Core Products, namely, SKB264 and A166.

A166 is a differentiated NDA registration-stage HER2 ADC positioned as a late-line monotherapy to treat advanced HER2+ solid tumors.

As of the Latest Practicable Date, we had established a pipeline of 14 clinical-stage drug candidates, including five in pivotal trial- or NDA registration-stage.