On January 9th, Suzhou XinnoVie Pharmaceutical Technology Co., Ltd. (XinnoVie) saw the status of its application for listing on the Shanghai Stock Exchange's STAR Market change to "under inquiry." Haitong Securities is its sponsor, and the company aims to raise 2.94 billion yuan. According to the prospectus, the company is an innovative pharmaceutical firm focused on addressing significant unmet clinical needs globally. It is disease-oriented, committed to translating innovation into clinical value, and providing patients with optimal therapeutic drugs within their disease areas.
The company has established a two-tier innovative drug pipeline structure described as "1(NDA)+3(Phase III)+N" and has initially achieved a "research-sustaining-research" model through global business development (BD) licensing or transfers. As of the prospectus signing date, the company has developed 10 major innovative drug pipelines targeting substantial disease areas with broad market potential, including oncology and anti-infectives. Among these: (1) In the oncology field, XNW5004 (an EZH2 inhibitor), XNW27011 (a Claudin18.2-targeted ADC), and XNW28012 (a TF-targeted ADC) are all in Phase III or pivotal clinical study stages. These drugs have demonstrated excellent clinical efficacy, potentially offering "from scratch" or "from good to better" treatments for major diseases such as pancreatic cancer, gastric cancer, prostate cancer, and peripheral T-cell lymphoma. These pipelines have all received Breakthrough Therapy Designation from China's Center for Drug Evaluation (CDE). Furthermore, XNW27011 and XNW28012 have received Fast Track Designation (FTD) from the U.S. FDA, and XNW28012 has also obtained Orphan Drug Designation (ODD) from the U.S. FDA. (2) In the anti-infective field, the New Drug Application (NDA) for Imipenem/Cilastatin/XNW4107 for Injection (a compound formulation consisting of the company's self-developed novel β-lactamase inhibitor funobatan (XNW4107) combined with imipenem and cilastatin sodium) for treating hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Gram-negative bacteria has been accepted. It is expected to gain approval for market launch in 2026, which will help address the challenge of antibiotic resistance in Gram-negative bacteria in China. This drug has received Qualified Infectious Disease Product (QIDP) certification and Fast Track Designation (FTD) from the U.S. FDA.
Beyond the aforementioned pipelines in the NDA and late-stage clinical phases, the company also has several early-stage pipelines with differentiated mechanisms and high clinical value advancing steadily and in an orderly manner. The number of regulatory facilitation qualifications obtained by the company's pipelines ranks among the top domestic pharmaceutical companies.
Bolstered by a global vision and strategic layout, the company has initially realized a "research-sustaining-research" model through global BD activities. The company's first drug is expected to launch in 2026, marking its entry into an integrated growth phase driven by R&D, BD, and sales, as detailed below: (1) The company has initially normalized BD transactions, rapidly realizing pipeline value while also demonstrating recognition of its R&D capabilities and pipeline value by multinational pharmaceutical companies and well-known domestic listed pharmaceutical firms. As of the prospectus signing date, the company has four ongoing out-licensing or transfer collaborations for its pipelines. Partners include renowned multinational companies like Astellas and prominent domestic listed companies such as Everest Medicines (01952) and China Antibody (03681). The total agreed transaction value (including upfront payments, milestone payments, etc.) has exceeded $2 billion. Notably, the company received an irrevocable upfront payment of $130 million (pre-tax) in 2025 and is expected to achieve profitability at the company level (after deducting non-recurring gains and losses) for that year, having initially established the "research-sustaining-research" model. (2) The company's first innovative drug, Imipenem/Cilastatin/XNW4107 for Injection, is expected to receive domestic approval and launch in 2026. Three other drugs, XNW5004, XNW27011, and XNW28012, have received CDE Breakthrough Therapy Designation and are projected to successively achieve domestic market launches between 2027 and 2028, which will sustainably drive rapid growth in the company's drug sales revenue.
Financially, for the fiscal years 2022, 2023, 2024, and the first half of 2025, the company reported net losses of approximately -463 million yuan, -427 million yuan, -386 million yuan, and -374 million yuan, respectively.
