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New News from Jiangbei Innovative Drugs Recently, the enterprise in the Biomedical Valley Park of the New District, Vitis Life Sciences (stock code: 9887.HK), announced that its core product, Vilexin®, has been granted orphan drug status by the European Commission for the treatment of extrapulmonary neuroendocrine cancer.
It is worth noting that just in the middle of last month, this innovative drug also received the fast-track qualification recognition from the US Food and Drug Administration (FDA), entering the “fast lane” for review. In less than half a month, it obtained two authoritative recognitions.
01 What is an “orphan drug”?
Before introducing this innovative drug, let’s first understand what an “orphan drug” is.
An orphan drug refers to a medication used for diagnosing, preventing or treating rare diseases that have a small number of patients and are often overlooked. According to the definition in the European Union, such diseases typically account for no more than five out of every ten thousand people in the population and can be life-threatening or cause chronic disability.
Although rare, there are always patients who are desperately waiting. And the high research and development costs and the small market have made few pharmaceutical companies pay attention to the research and development of rare disease treatment drugs. Therefore, each country provides several key incentives for the research and development of orphan drugs.
Take the European Union as an example. There is a “market ten-year monopoly” measure: Innovative drugs that obtain orphan drug qualification recognition will enjoy a ten-year market monopoly from the date of the approval of the marketing authorization. During this period, the regulatory authorities of the European Union and its member states will not approve other enterprises to launch similar drugs for the same indication. In addition, there are also financial reductions, subsidies, etc.
02 Why is it Villysin®?
Before a series of supportive measures, obtaining orphan drug qualification recognition means that the global development process of the drug will enter the “fast lane”; at the same time, the threshold for obtaining orphan drug qualification recognition is also very strict, with extremely high requirements for both the drug itself and the company’s technical platform.
This time, Vilexin® was recognized because of its outstanding potential in treating extrapulmonary neuroendocrine cancer. This is a rare malignant tumor, and currently there are no effective treatment methods in clinical practice. Vilexin® is a dual-antibody drug that targets both PD-L1 and 4-1BB – it can not only relieve the “immune brake” of PD-1/PD-L1, but also activate the “call to action” of T cells, more effectively identifying and eliminating tumor cells.
The unique design brings an innovative mechanism of action. Currently, Vilexin® has demonstrated global first-in-class or superior potential in phase II or registration clinical trials for three indications: non-small cell lung cancer, small cell lung cancer, and extrapulmonary neuroendocrine cancer.
The drug is innovative enough and the clinical data is excellent as well. Therefore, the reason why Vilexin® has gained recognition from international regulatory agencies is self-evident.
It is worth noting that as early as 2024, this innovative drug from Jiangbei has already received the breakthrough therapy drug recognition from the Drug Evaluation Center of the National Medical Products Administration, as well as the orphan drug recognition from the US FDA. The innovative forces from the new district are shining on the world stage again and again, bringing new hope to global cancer patients.
03 This road has been traveled by them for over a decade.
Behind the shining moments lies a decade-long unwavering commitment.
Since its establishment in 2012, the VistaliBo team has been focused on innovation and has been dedicated to developing innovative treatments for tumors, autoimmune diseases, and other major illnesses. This is undoubtedly a difficult and rarely-trodden path, but the team has persisted and forged its own path of innovation breakthrough. For instance, at the beginning of the company’s establishment, when many pharmaceutical companies were flocking into the popular PD-1/PD-L1 market, VistaliBo chose a “differentiation” approach, focusing on addressing diseases that existing therapies could not treat.
This persistence stems from a profound understanding of the patients’ needs, and is also driven by science.
The team has established several independent core technology platforms, and based on these, they have built a rich pipeline covering 14 innovative candidate drugs. Among them, 7 have entered the clinical stage, and 4 core products are at the forefront of global clinical progress.
Last year, VeriCognition went public on the Hong Kong Stock Exchange, and the capital market voted with real money for its innovative value. From the dedicated research and development under the Dragon Mountain, to frequent appearances on the international stage, VeriCognition is taking steps one by one and becoming the core leader on the race track.
We are looking forward to the early availability of Wiliexin® for patients all over the world, and we also hope that more innovative drugs from Jiangbei will make great progress and go global!
