Zelgen Gains After Chinese Drugmaker’s New Cancer Medicine Wins Orphan Status in US
Tang Shihua
DATE:  Aug 09 2024
/ SOURCE:  Yicai
Zelgen Gains After Chinese Drugmaker’s New Cancer Medicine Wins Orphan Status in US Zelgen Gains After Chinese Drugmaker’s New Cancer Medicine Wins Orphan Status in US

(Yicai) Aug. 9 -- Shares in Zelgen Biopharmaceuticals advanced as much as 3.5 percent today after the Chinese drugmaker said that its experimental oncology treatment has been granted orphan drug status in the US, making it eligible to receive substantial government support that will allow it to complete clinical trials, market registration and commercialization in the country.

Zelgen’s share price [SHA:688266] as trading up 0.7 percent at CNY54.81 (USD7.60) as of 1 p.m. today. Earlier in the day it hit CNY56.30.

ZG006 is a small cell lung cancer injection produced by an antibody research and development platform under unit Gensun Biopharma that is still under development, the Kunshan-based developer of first-in-class, or prototype, medicines said yesterday. It targets tumor cells with T-cell specificity and there is no such drug available yet in the world.

Orphan drug designation is given to treatments for rare medical conditions that would not be profitable to produce without government support. The backing of the US Food and Drug Administration will help pay for the new drug’s ensuing research and development, registration, and commercialization. There will be a seven-year period of market exclusivity, tax credits on clinical trial fees, an exemption from the new-drug application charge as well as other benefits.

Zelgen still needs to negotiate with the FDA on subsequent clinical trials and the registration filing process. So, there are still uncertainties on whether the injection will get the go-ahead in the US and when it will hit the market, it added.

Zelgen has a R&D center in Shanghai's Zhangjiang Hi-Tech Zone and is headquartered in Kunshan and California, according to its website. It also a pilot production line for innovative drugs at its Kunshan plant.

Editor: Kim Taylor

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Keywords:   Orphan-Drug Designation,FDA,New Medicine Development,First-in-Class Medicine,Cancer Treatment,Antibody Medicine,Gensun Biopharma,Zelgen Biopharma