Multiple technological routes shift from 'following' to 'leading'
2026-04-20
Recently, China's innovative pharmaceutical industry has made a series of breakthroughs: Rongchang Biotechnology's independently developed antibody conjugated (ADC) drug vediximab, a new indication, has been officially approved for market by the National Medical Products Administration; Reindeer Biology has signed a technology cooperation authorization agreement with the Brazilian research institution, the Butantan Institute, to develop CAR-T cell therapy for the treatment of hematological tumors in Brazil; Corning Jerry announced that its independently developed human epidermal growth factor receptor 2 (HER2) bispecific antibody (hereinafter referred to as "bispecific antibody") drug, anlitumumab combined with docetaxel, has achieved the primary endpoint of overall pathological complete response rate in phase III clinical trials, demonstrating the effectiveness of the drug. This vividly depicts the collaborative innovation of multiple technological routes for innovative drugs in China. More and more Chinese innovative pharmaceutical companies are accelerating their transition from 'following' to 'running parallel' and partially 'leading' in global competition through source innovation. ”Qian Hai, Director of the New Drug Research Center of the National Key Laboratory of Multi target Natural Medicine at China Pharmaceutical University, believes that China's biopharmaceutical industry has become an important force in global pharmaceutical innovation. ADC technology reserves present a multidimensional pattern. Among all innovative drug technology routes, ADC is the "ace track" for Chinese pharmaceutical companies in global competition. According to data, China accounts for over 50% of the global ADC projects under development. ADC drugs are like a 'biological missile'. ”Han Feng, Executive Deputy Director of the Medical Basic Research Innovation Center for Major Cardiovascular and Cerebrovascular Diseases of the Ministry of Education and a professor at Nanjing Medical University, made an analogy that inside this "missile", highly specific antibodies are like a "navigation system", and highly active small molecule toxic drugs are like a "warhead", connected by a chemical linker. After the drug enters the body, highly specific antibodies accurately recognize and bind to specific targets on the surface of cancer cells, and then the drug enters the interior of the cancer cells as a whole, releasing toxic drugs - microtubule inhibitors or DNA damaging agents, thereby killing the cancer cells. Rongchang Biotech's vediximab is China's first original ADC drug and the first ADC in China to receive dual recognition as a breakthrough therapy in both China and the United States. Subsequently, multiple domestic ADC drugs such as Luchangshatuzumab, Ruikangqutuzumab, and Boduqutuzumab were launched. The technical reserves of Chinese pharmaceutical companies regarding ADC have presented a multidimensional pattern. ”Qian Hai believes that the differentiated technology platforms of Chinese pharmaceutical companies inject core impetus into the research and development of ADC drugs in China. Among them, Rongchang Biological ADC platform can optimize linkers and payloads, with proprietary bridging coupling technology and the ability to develop linkers, payloads, and coupling processes; The platform independently developed by Kolombotai covers the entire lifecycle of drug development, and can systematically design and optimize the three key components of ADC: antibodies, payloads, and linkers. It is worth noting that dual targets are also becoming an important direction for Chinese pharmaceutical companies to break through in ADC technology. This not only has the potential to overcome tumor heterogeneity and single target resistance problems, but also significantly improve drug efficiency and anti-tumor activity through synergistic effects between targets. ”Qian Hai believes that the most representative is the dual antibody ADC drug BL-B01D1 under development by Baili Tianheng. This drug effectively overcomes drug resistance caused by a single target by simultaneously blocking two targets. The relevant research results have been published in the international academic journal The Lancet. The expansion of ADC drug targets is still ongoing, with popular targets and more differentiated innovative targets becoming the focus of exploration for Chinese innovative drug companies. Dual antibody drugs shine on the international stage. Dual antibody is another driving force behind the rapid rise of innovative drugs in China, following ADC. At the 2025 Annual Meeting of the American Society of Clinical Oncology, China contributed nearly half of the world's dual antibody research reports. Double antibody is an artificially designed antibody molecule that can simultaneously bind to two different antigens or two different epitopes on the same antigen. The mode of action of dual antibody drugs is like 'killing two birds with one arrow', achieving a synergistic effect of '1+1gt; 2' by simultaneously targeting two targets with one drug molecule. ”Qian Hai introduced that as one of the core directions of next-generation antibody therapy, dual antibodies have shown therapeutic potential in fields such as tumors and autoimmune diseases. Several interviewed experts believe that the rapid rise of Chinese bispecific antibodies is mainly due to three advantages: focus and differentiation in target selection, engineering innovation in molecular design, and efficiency advantages in clinical development. In terms of target selection, Chinese pharmaceutical companies highly focus on the "golden combination" of programmed death receptor-1/vascular endothelial growth factor (PD-1/VEGF). In 2024, Kangfang Biotechnology independently developed the world's first PD-1/VEGF dual drug, Ivoxidan Kang; In 2025, Sansheng Pharmaceutical and Pfizer reached a cooperation agreement on PD-1/VEGF dual antibody SSGJ-707. In addition, targets related to autoimmunity, inflammation, tumors, and other fields have also entered the research and development map of Chinese pharmaceutical companies' dual antibody drugs, and have attracted attention from multinational pharmaceutical companies: Quanxin Biotechnology's dual antibody project targeting TSLP and IL-33 has been authorized to Roche Pharmaceuticals for $1.07 billion; Zhengda Tianqing's dual antibody ADC based on mesenchymal epithelial cell transformation factor (c-MET) and EGFR has entered phase I clinical research. Xinda Biotech is currently advancing the global phase III clinical study of the dual drug IBI363. Their team achieved strong binding and excitatory activity of IBI363 on tumor specific T cells through dual antibody design of PD-1 and interleukin-2. We will continue to invest in the research and development of core molecules, deepen our understanding of molecular mechanisms through a large amount of clinical data, and use clinical feedback to support research and development. ”Zhou Hui, Chief R&D Officer of Xinda Biological Tumor Pipeline, said. If the target is the "beacon" for the development of bispecific drugs, the engineering innovation of molecular design greatly enhances the industrialization, safety, stability, and anti-tumor activity of bispecific drugs. WuXiBody platform from WuXi Biologics, with its unique design, can save 6-18 months of research and development time for each project; Baiaosaitu's dual antibody development platform can generate antibodies with diversity and affinity; Kangfang Biotechnology's Tetrabody technology platform has overcome challenges such as low expression levels, process development obstacles, and non drug resistance, and has helped develop more than 15 globally leading dual resistance, multi resistance, dual resistance ADC drugs. At the same time, Chinese companies have focused on specific clinical needs and accelerated the development of dual drug drugs. Han Feng believes that for diseases such as gastric cancer, esophageal cancer, and nasopharyngeal cancer, Chinese companies utilize large patient populations and efficient clinical trial systems to shorten patient recruitment and trial cycles, quickly validate efficacy, and promote the process of drugs from preclinical to market launch. CAR-T cell therapy continues to break through. CAR-T cell therapy is a revolutionary technology in global cancer treatment, and its core idea is to use genetic engineering to modify the patient's own immune cells, enabling them to accurately recognize and attack cancer cells. At present, there are mainly two cutting-edge technological paths, namely in vivo generated CAR-T and spot CAR-T cell therapy. China's CAR-T cell therapy is at the forefront of the world. ”Qian Hai introduced that compared with traditional cancer treatment methods, CAR-T therapy is like equipping T cells with "GPS navigation", which can accurately identify tumor cells. CAR-T cells can also survive in the patient's body for a long time, forming a sustained "anti-cancer defense line". For certain blood tumors, CAR-T drugs can achieve long-term remission or even functional cure, with a clinical remission rate exceeding 80%. In March of this year, AstraZeneca announced the construction of a specialized commercial production and supply base for cell therapy in the Lingang New Area of the Shanghai Free Trade Zone. Behind multinational pharmaceutical companies' bet on China is the indispensable role of China's CAR-T cell therapy technology in the global biopharmaceutical landscape. Data shows that currently, 15 autologous CAR-T drugs have been approved worldwide, with 8 approved in China and 7 approved in the United States. And more CAR-T research is also advancing simultaneously: by the end of 2025, China has registered over 300 CAR-T clinical trials, surpassing the United States for the first time. The CAR-T drug Xidaqiolon, targeting BCMA (B cell mature antigen), is the first original CAR-T product in China to successfully "go global". It adopts a unique dual epitope design, significantly enhancing the grabbing ability and affinity of CAR-T cells for tumor cells, thereby achieving extremely high remission rates in clinical practice. At present, the cumulative number of patients treated with Xidaqiolon has exceeded 10000. We will also be committed to utilizing validated CAR-T development platforms to explore opportunities for in vivo CAR-T and allogeneic therapies. ”Legendary Biotech CEO Huang Ying said. The continuous source innovation of CAR-T drugs goes far beyond the development of successful products. Breaking through the solid tumor barrier, promoting the large-scale production of spot CAR-T, and expanding the application of CAR-T in autoimmune diseases and other fields are becoming new challenges that Chinese research teams and biopharmaceutical companies are committed to tackling. In the future, with the emergence of more innovative drugs, the mode of cancer treatment is expected to shift from fighting tumors to reshaping the immune system, and from passive defense to active clearance. At that time, humanity may be one step closer to the ultimate goal of conquering cancer. (New Society)
Edit:WENWEN Responsible editor:LINXUAN
Source:Science and Technology Daily
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