New Stock News | Sinotau Pharmaceutical Passes HKEX Hearing, Becoming China's First Company to Obtain Marketing Approval for an Innovative Radiopharmaceutical

According to the disclosure by the Hong Kong Stock Exchange on October 28, Beijing Sinotau International Pharmaceutical Technology Co., Ltd. (referred to as "Sinotau Pharmaceutical") has passed the listing hearing of the Main Board of the Hong Kong Stock Exchange, with GF SEC, CICC, and CITIC SEC as its joint sponsors. According to a report by CIC, Sinotau Pharmaceutical is the first company in China to (i) obtain marketing approval for an innovative radiopharmaceutical; (ii) obtain a production license for an innovative radiopharmaceutical as an MAH; and (iii) complete a registered clinical trial of a therapeutic radioligand and have its NDA accepted by the NMPA. The prospectus shows that Sinotau Pharmaceutical is committed to developing and commercializing diagnostic and therapeutic radiopharmaceuticals with significant market potential. Founded in 2005, as of the Latest Practicable Date, the company has established a staged, indication-oriented development pipeline comprising 13 assets, of which 5 were independently discovered and developed by the company and 3 were independently developed by the company. The company's pipeline includes two core products, XTR008 and XTR004, as well as two major products, XTR003 and XTR006. XTR008 is a 177Lu-labeled radioligand targeting somatostatin receptor ("SSTR") in the registration stage for the treatment of neuroendocrine neoplasms ("NEN"). It is a generic version of Lutathera and is the first drug in its class to submit an NDA to the NMPA as a Class 3 chemical drug, and is expected to obtain marketing approval in December 2026. XTR004 is an 18F-labeled diagnostic radioligand targeting mitochondrial complex I for PET-myocardial perfusion imaging ("MPI"). XTR003 is currently the world's first and only 18F-labeled imaging agent for myocardial fatty acid metabolism, used to detect myocardial viability. XTR006 is an 18F-labeled tubulin-associated unit ("tau")-targeted positron emission tomography ("PET") diagnostic radioligand for the diagnosis of suspected Alzheimer's disease ("AD") or mild cognitive impairment ("MCI") caused by AD dementia. According to CIC, the incidence of NEN globally and in China is expected to grow from 576,000 cases and 61,800 cases in 2025 to 771,600 cases and 74,300 cases in 2036, respectively. As of the Latest Practicable Date, Lutathera is the only radioligand therapy globally that has obtained full marketing approval for the treatment of GEP-NET. The NDA for XTR008 has been accepted by the NMPA, making it the candidate product with the most advanced clinical development progress in China. As of the Latest Practicable Date, Sinotau Pharmaceutical has launched three products in China, namely XTR005 under the trade name Ouweining, adenosine injection under the trade name Oudale, and 18F-FDG injection. The company's core business model involves the development and commercialization of radiopharmaceuticals in three strategically focused areas, namely (i) oncology, (ii) neurodegenerative diseases, and (iii) cardiovascular diseases. The company has established three in-house production facilities, one located in Wuxi, Jiangsu Province, one in Zhongshan, Guangdong Province, and another in Mianyang, Sichuan Province. As of the Latest Practicable Date, the total gross floor area of these facilities exceeds 40,000 square meters, with a total of 21 commercial-scale production lines. Financially, for 2024, 2025, the six months ended June 30, 2025, and the six months ended June 30, 2026, the company's revenue was RMB44.064 million, RMB99.210 million, RMB36.908 million, and RMB61.254 million, respectively; during the same periods, gross profit was approximately RMB3.378 million, RMB15.023 million, RMB12.021 million, and RMB17.987 million, respectively.