Jiangbei Innovative Pharmaceuticals

More good news.

Recently, Velizipor (stock code: 9887.HK), an enterprise in the Biomedical Valley Park of the New District, announced that its core product, Velizipor?, has been granted Orphan Drug status by the European Commission for the treatment of extrapulmonary neuroendocrine carcinoma.

It is worth mentioning that in the middle of last month, this innovative drug also obtained the fast-track qualification granted by the U.S. Food and Drug Administration (FDA), entering the review of the "fast track". Less than half a month, take two authoritative recognition.

01 What is an Orphan Drug?

Before introducing this innovative drug, let's first understand the "orphan drug".

Orphan drugs, which areDrugs for the diagnosis, prevention or treatment of rare diseases with low patient numbers that are easily overlookedThe EU definition of these diseases is that they usually affect no more than five in 10,000 of the population. In the EU definition, these diseases usually affect no more than 5 per 10,000 of the population and can be life-threatening or chronically disabling.

Although rare, there are always patients waiting in the wings; and high R&D costs and small markets have led few pharmaceutical companies to focus on the development of therapeutic drugs for rare diseases. As a result, countries provide several key incentives for orphan drug development.

In the European Union, for example, there is a "10-year market exclusivity" initiative: innovative medicines that have been granted orphan drug status.Ten years of market exclusivity from the date of marketing authorization approvalDuring this period, the EU and member state regulators will not authorize the marketing of similar drugs for the same indications by other companies. In addition, there are financial reliefs and subsidies.

02 Why Verisign??

With a series of support measures in place, being recognized as an orphan drug means that the process of global drug development will be put on the "fast track"; at the same time, the threshold for orphan drug eligibility is also very stringent, with very high requirements for both the drug itself and the company's technology platform.

Verisign? was recognized for its outstanding potential in the treatment of extrapulmonary neuroendocrine carcinoma. This is a rare malignant tumor for which there is currently a lack of effective clinical treatments. Verisign? isA dual-antibody drug that targets both PD-L1 and 4-1BB--It can not only release the "immune brake" of PD-1/PD-L1, but also activate the "charge" of T-cells, which can identify and destroy tumor cells more effectively.

Unique design leads to innovative mechanism of action. Currently, Verisign? has demonstrated in Phase II or registrational clinical trials in three indications: non-small cell lung cancer, small cell lung cancer and extrapulmonary neuroendocrine carcinomaWorld's first or best-in-class potentialThe

The drug is innovative enough, the clinical data is equally good, and it is easy to see why Verisign? has won the recognition of international regulators.

It's worth noting that as early as 2024, this innovative drug from the north of the riverHas been recognized as a breakthrough therapeutic drug by the National Drug Administration's Drug Review Centeras well asOrphan Drug Designation by the US FDA. The innovative power from the new district is shining on the world stage again and again, bringing new hope to global tumor patients.

03 They've been traveling this road for more than ten years.

Behind the highlights is more than a decade of perseverance.

Since its inception in 2012, the team at Velichipo has anchored itself in innovation, theFocused on developing innovative therapies for oncology, autoimmune diseases and other major diseasesThe team has been working hard on this project for a long time. This is undoubtedly a difficult and rare road, but the team insisted on coming out of their own innovative breakthrough road. For example, at the beginning of the company's founding, when many pharmaceutical companies piled into the hot track of PD-1/PD-L1, VILI Zhibo chose to "differentiate" the path, focusing on solving diseases that cannot be treated by existing therapies such as PD-1/PD-L1.

This persistence is rooted in a deep insight into patient needs and is even more science-driven.

The team has established several proprietary core technology platforms, on which it has built a rich pipeline of 14 innovative drug candidates. Among them.7 have entered the clinical stage and 4 core products are at the forefront of the global clinical progressThe

Last year, Vilazbo was listed on the Hong Kong Stock Exchange, and the capital market voted for its innovative value with real money. From dedicated R&D under the Dragon King Mountain to frequent appearances on the international stage, Vilicom is becoming the core leader on the track, one step at a time.

Looking forward to Verisign?

Early benefits for patients worldwide

We also look forward to more innovative medicines from Jiangbei

Moving forward to the world~