On June 23rd, the BeiGene bispecific HER2 inhibitor Baihetam (injectable Zenidatuzumab) was officially supplied in China and began clinical use in multiple medical institutions across the country. As a bispecific antibody approved for targeted treatment of HER2 overexpressing biliary tract cancer in China, the first batch of drugs will quickly be launched in hospitals and pharmacies in over 100 cities across the country, benefiting patients with biliary tract cancer (BTC). Dr. Wu Xiaobin, President and Chief Operating Officer of Baekje Shenzhou, said: "This time Zenidastumab has accelerated the realization of commercial supply under the joint efforts of many parties, bringing new treatment options for patients with biliary tract cancer, and also marking that Baekje Shenzhou has helped digestive tract tumors represented by biliary tract cancer further move towards the stage of precision treatment." Biliary tract cancer mainly includes gallbladder cancer (GBC) and bile duct cancer (CCA), with a high incidence rate worldwide and an upward trend in China. Due to the high malignancy, rapid progression, and atypical symptoms of biliary tract cancer, most patients are already in the advanced or metastatic stage at the time of diagnosis and cannot undergo surgical resection. In order to meet the urgent clinical needs, BeiGene's commercialization team has coordinated with multiple parties and used various methods such as air freight to accelerate supply, ensuring that drugs can arrive quickly and efficiently in various places, and winning more treatment time and hope for patients waiting for effective treatment drugs. It is reported that the first batch of drugs has successively arrived in Beijing, Shanghai, Guangzhou and other places, and started serving patients. Dr. Zhou Jun prescribed Zenitazumab to a patient at Tsinghua Chang Gung Hospital in Beijing, and stated that "biliary tract cancer that has lost the opportunity for surgery has a relatively low survival rate in advanced stages or after metastasis. The clinical application of Baihetan (injection of Zenitazumab) will bring breakthrough therapeutic drugs for the treatment of HER2 overexpressing advanced biliary tract cancer, and even significant breakthroughs in the precision treatment of biliary tract cancer and digestive system malignancies in China. ”Zenidatuzumab is a HER2 targeted bispecific antibody that enhances its ability to resist HER2 by simultaneously targeting two non overlapping epitopes (ECD2 and ECD4) of HER2, and induces multiple killing effects (including CDC, ADCC, ADCP, etc.), promoting tumor cell death. Baihetan (injection of Zenitazumab) has been made accessible, aiming to bring good news to more HER2 overexpressing advanced and metastatic biliary cancer patients across the country who are urgently waiting for new treatment options, allowing patients to achieve clinical medication early and prolong their precious lives. Dr. Wu Xiaobin stated, "In the future, we will continue to work together with all parties to accelerate the improvement of the accessibility and affordability of innovative drugs, so that more cancer patients in urgent need of clinical treatment can receive high-quality innovative drug treatment in a timely manner, and improve survival benefits." Zenidatuzumab was conditionally approved by the National Medical Products Administration (NMPA) on May 27, 2025, for the treatment of HER2 overexpressing (IHC3+) unresectable locally advanced or metastatic biliary tract cancer patients who have received systemic treatment in the past. Previously, Zenidatuzumab was approved for marketing by the US Food and Drug Administration (FDA) in November 2024, and received a positive opinion from the European Medicines Agency (EMA) Committee for Human Use (CHMP) in April 2025, supporting its use in the treatment of adult patients with HER2 positive (IHC 3+) unresectable or metastatic biliary tract cancer (BTC). (New Society)