BioDlink congratulates Junshi Biosciences on receiving IND approval from China'sNMPA for JS212, the company's first bispecific ADC.
JS212 combines dual-targeting antibody technology with a cytotoxic payload, representing a next-generation therapeutic.
BioDlink provided end-to-end development and manufacturing support, showcasing its industry-leading ADC capabilities.
Approval marks a key milestone in the development of next-generation antibody-drug conjugates.
SUZHOU, China, May 8, 2025 /PRNewswire/ -- BioDlink, a leading global CDMO, proudly congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China to initiate clinical trials for the JS212 injection — Junshi Biosciences' first bispecific antibody-drug conjugate (ADC).
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JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 — two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.
Dr. Jun Liu, CEO and Executive Director of BioDlink, stated: "As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in ADC research, development and manufacturing. The IND approval of JS212 — a technically demanding bispecific ADC — highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We're honored to support the advancement of this important program."
Dr. Jing Tong, Deputy Director of Junshi Biosciences' Innovation Research Institute, shared: "We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future."
BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.
With a comprehensive ADC platform supported by key R&D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink's quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.
About BioDlink Biopharm Co., Ltd.
With over 10 years of experience in antibody and ADC drug development, BioDlink offers full-service CDMO solutions for biologic drugs — from early-stage R&D through to commercial production.
The company has built integrated platforms for biologics and bioconjugates, offering process development, scale-up, and quality analytics solutions. Its scalable manufacturing lines include top-tier OEB-5 facilities for high-potency ADCs, with commercial antibody production already underway.
BioDlink's quality management system complies with regulatory requirements in China, the U.S., the EU, and Japan. The company has successfully supported over 100 projects with development, clinical filings, and manufacturing services. In addition, the company has already passed near 100 GMP audits, including a zero-defect EU QP audit, with its quality systems earning worldwide recognition.
Guided by its "Empowering Innovation with Quality to Grow Together" mission, BioDlink is dedicated to enabling partners and advancing global healthcare through excellence in biologics.
About Shanghai Junshi Biosciences Co., Ltd.
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company's products have received approvals in China and international markets, one of which is toripalimab, China's first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19.
With a mission of "providing patients with world-class, trustworthy, affordable, and innovative drugs," Junshi Biosciences is "In China, For Global." At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.).
