New stock news | NewLink Bio submits application to Hong Kong Stock Exchange, focusing mainly on the development of independently researched and developed innovative precision immune-oncology drugs.

According to the disclosure by the Hong Kong Stock Exchange on October 31st, NewLink Bio has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with Goldman Sachs and CITIC SEC as joint sponsors. The prospectus shows that NewLink Bio was established in 2016 and is a global biotechnology platform company that adopts a strategy for development in multiple therapeutic areas. Since its establishment, the company has focused on the development of innovative precision immune oncology drugs for cancer treatment. To further supplement its independent research and development pipeline, the company is seeking collaboration opportunities for the clinical development and commercialization of candidate drugs in order to better seize market opportunities. The company recently adopted a new business model, aiming to select and advance high-value therapeutic assets through strategic partnerships and specialized subsidiary entities. With this model, the company has become a biotechnology platform enterprise that establishes separate subsidiary companies to focus on the development of therapy-guided assets, thereby strengthening supervision, focusing on operations, and optimizing risk management. NewLink Bio's core product givastomig is a novel bispecific antibody ("bsAb") that can simultaneously target the tumor antigen Claudin18.2 ("CLDN18.2") which is primarily expressed in gastric cancer, esophageal cancer, and pancreatic cancer, as well as the T cell co-stimulatory molecule 4-1BB. With the widespread expression of CLDN18.2 in multiple tumors, givastomig can target various indications, including gastric/esophageal adenocarcinoma, biliary tract cancer, and pancreatic ductal adenocarcinoma. Compared to existing CLDN18.2 antibodies and 4-1BB agonistic antibodies, Givastomig (also known as "ABL111", "TJ033721", and "TJCD4B") has two core advantages: firstly, even in tumors with low CLDN18.2 expression, givastomig can effectively bind, making it potentially more widely applicable to patients with different levels of CLDN18.2 expression; secondly, its 4-1BB antibody component only activates T cells after binding to tumor cells, achieving precise local immune activation against the tumor. This CLDN18.2-targeted local T cell activation mechanism can enhance anti-tumor immunity, rejuvenate exhausted T cells, and significantly reduce the risk of systemic side effects, such as the hepatotoxicity commonly seen in 4-1BB drugs in preclinical studies and clinical trials. According to Frost & Sullivan reports, the estimated global market size for first-line treatment of GEA, BTC, and PDAC (excluding Greater China and Korea) in 2024 are $8.9 billion, $1.8 billion, and $4.4 billion, respectively, and are expected to reach $13 billion, $2.9 billion, and $6.4 billion by 2034. The company has completed Phase I clinical research part 1a and safety evaluation of Phase 1b dose escalation research. The company will initiate a randomized Phase II study in early 2026, and after submitting the clinical trial plan in August 2025, the company has not received any opposition or concerns from the US FDA regarding a Phase II combination treatment trial of givastomig for CLDN18.2-positive and PD-L1-positive GEA patients. In addition to givastomig, as of the last actionable date, NewLink Bio has established a pipeline consisting of three clinical-stage projects, including two oncology projects uliledlimab and ragistomig, as well as an ophthalmology project VIS-101. Financially, for the fiscal years 2023, 2024, and the six months ended June 30, 2024 and 2025, NewLink Bio recorded total revenue figures of approximately -$20.2 million, -$28.617 million, $9.852 million, and -$4.999 million US dollars respectively.