Company Overview
MediLink Therapeutics was founded in 2020, headquartered in Suzhou (with a research branch in Boston, USA), and has established research institutions in Shanghai and Singapore. The company’s founder, Dr. Xue Tongtong, previously served as the general manager of Kelun-Biotech and has over 10 years of experience in the research and management of antibodies, small molecules, and ADC drugs, having been responsible for the development of multiple ADC and small molecule projects; co-founder Dr. Cai Jiaqiang has nearly 30 years of drug development experience, having led innovative drug development at Hansoh and Kelun, overseeing eight ADC projects including SKB264, SKB315, YL201, and YL202.
The management team also includes Dr. Qin Xuke, a senior expert in oncology who has worked at companies such as Kowa, Eli Lilly, and AstraZeneca (CMO), and Dr. Li Jia, former CFO of Rongchang Biologics with a Wall Street background (CFO). MediLink Therapeutics is committed to developing globally competitive innovative conjugated drugs and has applied for over a hundred ADC-related patents.
Technical Platform (TMALIN®)
The TMALIN® (Tumor Microenvironment Activable LINker-payload) technology platform developed by MediLink has several innovative features. The linkers designed by this platform can be specifically cleaved in the tumor microenvironment (TME), rather than relying on antibody-target cell endocytosis. This dual cleavage mechanism (extracellular TME cleavage + intracellular cleavage) allows ADCs to release drugs even when not internalized, thereby broadening the target selection range, enhancing tumor localization effects, and strengthening the bystander effect. The payload molecules of the TMALIN platform are camptothecin-based topoisomerase I inhibitors, which have high hydrophobicity and permeability, allowing for concentrated accumulation in the TME and improving the therapeutic window. ADCs prepared using the MediLink TMALIN platform exhibit high stability in circulation, effectively preventing drug loss; they also achieve a high drug-to-antibody ratio (DAR=8) with high homogeneity, without reversible Maleimide structures, and a drug loading rate of ≥90%.
Compared to traditional ADCs (such as Seagen’s hydrophobic branched nitrogen-containing (vc) linked MMAE technology), TMALIN ADCs have a higher DAR, better uniformity, and stronger in vivo stability, significantly enhancing efficacy and reducing off-target toxicity. In summary, the TMALIN platform can release drugs externally in tumors, achieve high DAR, and strong bystander effects, overcoming the challenges of traditional ADCs’ dependence on endocytosis and insufficient plasma stability.
Pipeline Layout
MediLink Therapeutics has laid out multiple ADC candidate drugs based on the TMALIN platform, covering various tumor indications:
YL201 (targeting B7-H3): Currently undergoing various clinical studies for solid tumors globally. In China, YL201 has initiated pivotal Phase III studies for advanced relapsed/metastatic small cell lung cancer (SCLC) and nasopharyngeal carcinoma. In January 2025, YL201 received breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the indication of relapsed/metastatic nasopharyngeal carcinoma, having previously also received BTD for relapsed small cell lung cancer. The I/II phase data from multi-center studies in China and the USA show encouraging anti-tumor activity and safety, with over 300 patients enrolled. Currently, global Phase II/III clinical data is continuously accumulating, and preparations for Phase III registration studies are actively underway.
YL202/BNT326 (targeting HER3, in collaboration with BioNTech): Early clinical studies are underway for EGFR mutation-positive NSCLC and hormone receptor-positive HER2-negative breast cancer. Phase II trials have been initiated in China, and a Phase I trial (INT-101-01) is ongoing in the USA. In June 2024, the FDA implemented a partial clinical hold on the Phase I trial of YL202 in the USA due to safety risks at high doses, with five patients experiencing grade 5 adverse events. MediLink is in communication with the FDA regarding the data, striving to lift the hold and continue the trial. BioNTech (BNT326) is a partner in this project.
YL205 (targeting NaPi2b): A novel ADC currently in the preclinical stage. NaPi2b is a phosphate transporter protein that is highly expressed in various tumors such as ovarian cancer, lung cancer, and breast cancer. MediLink has reported preclinical research results for YL205 at international conferences such as AACR2024, demonstrating good efficacy and safety.
YL217 (targeting Cadherin-17, CDH17): An ADC targeting gastrointestinal tumors (such as gastric cancer, colorectal cancer, and pancreatic cancer). Phase I clinical studies have been initiated in the USA. In early 2025, the company announced that YL217’s IND was accepted by the CDE in China, and it will simultaneously apply for clinical trials domestically.
YL242 (targeting VEGF): The first ADC targeting extracellular soluble VEGF. VEGF is a well-validated target for tumor angiogenesis, but traditional ADCs struggle to hit it. YL242 is developed using the TMALIN platform and received implied IND approval from the FDA in May 2025, with its IND also accepted by the NMPA in China. This project is about to initiate global Phase I clinical trials. Preclinical data for YL242 was presented at the AACR2025 conference, showing that this “non-endocytosed” ADC can effectively bind to VEGF in the tumor microenvironment.
YL211 (targeting C-MET): An ADC developed in global collaboration with Roche. Roche has obtained global exclusive rights to develop YL211 (targeting the tumor-associated receptor tyrosine kinase c-Met). Roche paid a $50 million upfront fee and committed to nearly $1 billion in milestone payments. The preliminary agreement states that MediLink will collaborate with Roche’s China Innovation Center to advance the Phase I clinical trial in China, with subsequent global development managed by Roche.
YL212/ZL-6201 (targeting LRRC15, DLL3): A new ADC developed in strategic collaboration with Zai Lab. In January 2025, MediLink announced that it would apply the TMALIN platform to jointly develop the LRRC15-targeting ADC (ZL-6201) with Zai Lab, which is currently in the preclinical stage, with IND submission expected in 2025. Additionally, MediLink is also advancing other pipelines in collaboration with partners, such as YL215 (targeting MSLN, in collaboration with Haihe Gaoke), YL221 (targeting EGFR, in collaboration with Heng Rui Bio), and YL222 (targeting PD-L1, in collaboration with Heng Rui Bio).
In summary, MediLink’s pipeline covers multiple innovative targets including B7-H3, HER3, NaPi2b, CDH17, VEGF, C-Met, and LRRC15, with several products already in clinical stages or preparing for submission, forming a layout that advances simultaneously in both domestic and international markets.
Strategic Collaborations
MediLink Therapeutics accelerates pipeline development through multiple international collaborations:
With BioNTech (2023-2024): In October 2023, BioNTech obtained global development licensing rights for MediLink’s HER3-targeting ADC (YL202/BNT326) with a $70 million upfront payment, with milestone payments potentially reaching $1 billion; in May 2024, the two parties further signed a collaboration agreement, with BioNTech paying an additional $25 million upfront for development rights to multiple MediLink TMALIN ADC projects, with milestones potentially reaching $1.8 billion. MediLink retains first negotiation rights in China (i.e., if BioNTech wishes to collaborate on development in China, MediLink enjoys priority negotiation rights).
With Roche (2024): In January 2024, MediLink signed a global collaboration licensing agreement with Roche, granting Roche global exclusive rights to develop YL211 (targeting c-Met), with MediLink receiving a $50 million upfront payment and nearly $1 billion in milestone payments. The agreement stipulates that MediLink will collaborate with Roche’s China Innovation Center to advance the Phase I clinical trial in China, with subsequent global development and commercialization managed by Roche.
With Amgen (2024): In October 2024, MediLink reached a research and supply collaboration agreement with Amgen to conduct a Phase I study of YL201 in combination with Amgen’s bispecific T cell therapy (Imdelltra™) for extensive-stage small cell lung cancer globally. This collaboration adopts a joint development model, with MediLink providing YL201 and Amgen providing therapeutic products, jointly assessing the combined efficacy.
With AstraZeneca (AZ) (2025): In January 2025, MediLink and AstraZeneca reached a clinical research collaboration agreement to initiate a multicenter open-label Phase I/II study combining YL201 with AZ’s PD-L1 inhibitor Imfinzi® (durvalumab) for various solid tumors. This study is jointly initiated by both parties to explore the potential of combining ADCs with immune checkpoint inhibitors.
With Zai Lab (2025): In January 2025, MediLink and Zai Lab announced a strategic collaboration to jointly develop a new LRRC15-targeting ADC (ZL-6201) using the TMALIN platform. Zai Lab is responsible for antibody discovery and leading global development, while MediLink provides technical platform and process support. This collaboration expands Zai Lab’s global oncology pipeline.
Additionally, MediLink has established clinical research collaborations with other organizations both domestically and internationally (such as Huazhong University of Science and Technology Union Hospital) and collaborates with domestic companies (such as Haihe Gaoke and Heng Rui Bio) on pipeline development. These collaborations encompass various models including global licensing, joint research, and joint clinical trials, with some involving milestone payments reaching hundreds of millions of dollars, reflecting the international recognition and commercial potential of the MediLink TMALIN platform.
Commercialization Layout
MediLink Therapeutics has planned the resources needed for future commercialization from the early stages of R&D: the founding team emphasizes the concept of simplifying processes and reducing costs to reserve space for subsequent industrial production. Currently, a research and process development base has been established in the Suzhou Biomedical Park, with technical centers in Shanghai and Singapore to support clinical and registration needs in both China and the USA. In terms of registration strategy, MediLink actively promotes dual submissions in China and the USA: for example, YL242 received implied IND approval from the FDA in 2025, while the clinical trial application has also been accepted by the CDE in China; YL217 has also received IND approval in China, and future applications for clinical trial qualifications in the USA will be submitted concurrently.
As the partners are mainly large multinational pharmaceutical companies, it is foreseeable that future commercial production will combine domestic CDMO with overseas factories, and local production will be achieved through collaboration or self-construction, although specific production capacity and commissioning plans have not yet been disclosed. In summary, MediLink is laying the foundation for the global launch and localized manufacturing of pipeline products by building an international registration system and a flexible production platform.
Financing Situation
Since its establishment, the company has received multiple rounds of capital support:
Series A (March 2021): Raised approximately 350 million RMB (about $50 million), including Series A1 led by Apricot Capital and Series A2 led by Loyal Valley Capital/Qiming Venture Partners, with participation from several institutions including Qiming Venture Partners, Loyal Valley Capital, and Apricot Capital.
Series B (March 2022): Completed a $70 million financing round, co-led by LYFE Capital and Qiming Venture Partners, with follow-on investments from Junlian Capital, Loyal Valley Capital, and Honghui Capital (HLC). The raised funds are mainly used for clinical research and technology platform development.
As of now, investors also include several well-known domestic and international venture capital institutions such as GGV Capital, Junlian Capital, Honghui Capital, and Apricot Capital. The company is well-funded, ensuring the clinical and production process scaling of its pipeline.
Peer Comparison
Platform Differences: The MediLink TMALIN platform features tumor microenvironment cleavability, high drug-to-antibody ratio (DAR≈8), and strong stability. In contrast, traditional ADC technologies (such as the first-generation Seagen platform’s vc-MMAE) typically have a DAR of around 4, uneven drug distribution, and require endocytosis to function; Daiichi Sankyo’s DXd platform also achieves a high DAR≈8 for ADCs, but TMALIN additionally emphasizes the external release mechanism in tumors, potentially further expanding target applications.
Pipeline Progress: MediLink has pushed multiple TMALIN-ADCs into clinical trials, with some products undergoing simultaneous registration studies in China and the USA and receiving breakthrough therapy designations. Currently, over a dozen ADC candidates have received clinical approvals in both China and the USA, placing the pipeline scale among the leading Chinese biopharmaceutical companies. Other domestic ADC development companies (such as Rongchang Biologics and Kelun-Biotech) also have proprietary platforms and products in development, such as Rongchang’s DLL3 ADC (in collaboration with AstraZeneca) and SKB264, but most focus on a single target and are still in early or Phase II stages; international giants like Seagen and Daiichi have multiple marketed ADCs (such as Trastuzumab Deruxtecan, which has been approved by the FDA) and more mature commercialization capabilities.
Valuation and Internationalization: MediLink has obtained considerable milestone payments through multiple collaborations and licensing deals with international pharmaceutical companies (BioNTech, Roche, etc.), demonstrating strong technical appeal and international recognition. As of 2023, significant merger and acquisition transactions in the global ADC field (such as Pfizer’s $43 billion acquisition of Seagen) and the launch of various companies’ products have driven industry valuations higher. In comparison, domestic companies have not yet seen similar-scale M&A events, with some like Rongchang generating revenue through international licensing collaborations (for example, obtaining milestone payments in the tens of billions), but overall internationalization remains limited. Overall, the MediLink TMALIN platform has clear technical advantages, rapid pipeline advancement, and is quickly expanding into the global market through international collaborations; its shortcoming may be that, compared to mature international giants, it has not yet had independently approved products, lower international sales experience, and brand recognition; compared to domestic peers, MediLink excels in the depth of technological innovation and scale of international collaboration but also faces fierce competition from both domestic and international competitors.
References: Company website, press releases, and media reports, etc.