核心产品处于临床阶段

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.

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.

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.

Founded in 2016, we are a science-driven, clinical-stage biotechnology company. We have two Core Products and 14 other pipeline product candidates.

According to the written confirmation issued by FDA in February 2019 and by NMPA in February 2020, FDA and NMPA agreed that this global MRCT Phase II trial would be the registrational trial and appropriate to support drug registration if the clinical results demonstrate good efficacy and safety profile.

We had not received any relevant regulatory agency’s concerns or objections to our clinical development plans as of the Latest Practicable Date, nor did any material unexpected or adverse changes had occurred since the date of issue of relevant regulatory approvals for LAE005.

Our Core Product, CU-20401, is a recombinant mutant collagenase that targets obesity, overweight, or other localized adipose accumulation associated metabolic diseases.

As of the Latest Practicable Date, we had built a broad portfolio of nine products and product candidates.

We enrolled the first patient in the Phase I clinical trial in September 2022 in China, and we expect to complete the Phase I clinical trial in the second quarter of 2024.

As of the Latest Practicable Date, our product pipeline consisted of three clinical-stage product candidates, including our Core Product LZ901, and four pre-clinical-stage product candidates.

We expect to complete the Phase II clinical trial in the second quarter of 2023, initiate a Phase III clinical trial in the second quarter of 2023, and file the BLA in the third quarter of 2024 for LZ901 to the NMPA.

In addition, we have received IND approval from the FDA in July 2022 for LZ901 and initiated a Phase I clinical trial in the U.S. in February 2023.