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» 23/07/2009 [Company watch]
China Aoxing Pharmaceutical Corp. Receives Renewal of GMP Certification for Capsule Dosage Form of Pharmaceutical Products
» 15/03/2010 [Industry news]
Recordati S.p.A And Lee Pharmaceutical Announce Partnership For Zanidip(R) In China
» 26/10/2009 [Finance]
China Growth to Remain Fast in Fourth Quarter, Official Says
» 17/08/2009 [Industry news]
Chindex Posts Profit on Product Sales, Health Services
» 07/05/2010 [Industry news]
Hong Kong: Recall of all products manufactured by Quality Pharmaceutical Lab Ltd
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Johnson & Johnson
»26/07/2009 [Company watch]
J&J Wins Approval to Market MDS Drug Without China Trials

Xian-Janssen, a division of Johnson & Johnson has launched a new drug in China. Dacogen (decitabine), a novel treatment for myelodysplastic syndrome, received SFDA approval through the Green Channel, an expedited approval process that the SFDA introduced in January 2009.

 
by: ChinaBio Today Xian-Janssen, a division of Johnson & Johnson has launched a new drug in China. Dacogen (decitabine), a novel treatment for myelodysplastic syndrome, received SFDA approval through the Green Channel, an expedited approval process that the SFDA introduced in January 2009. In Dacogens case, the SFDA allowed Xian-Janssen to begin marketing the drug in China based on trials done ex-China. Dacogen was granted an exception from trials because MDS is very rare in China – only 0.03% of the population has the disease – and no alternative treatment is available for it. When the SFDA instituted the Green Channel, it sought to speed up the regulatory process in a number of special situations. In particular, the agency listed four conditions that would make a potential drug eligible for consideration for expedited review. They are: 1. The active ingredient is extracted from an animal, plant or mineral composition and has not previously been launched in China; 2. The chemical API or its preparation and biologics have not been launched in China or abroad; 3. The drug is a novel compound with clinical efficacy in the treatment of AIDS, malignant tumor or seldom-seen disease; 4. The drug is a novel compound for a disease that does not have effective treatment. Dacogen qualifies for special treatment under provisions 3 and 4 of the list. Dacogen, which was developed by MGI and SuperGen (NSDQ: SUPG), received FDA approval in May 2006 following normal FDA procedures. Soon after it was approved, Ortho-McNeil-Janssen in-licensed the marketing rights of the drug. In another Green Channel case, Hutchison MediPharma has a cancer drug candidate, HMPL-012, that is seeking to be approved for clinical trials under the special provisions. The SFDA is often very slow in approving applications that allow a Phase I trial to begin. However, at the recent ChinaBio Partnering Forum, Samantha Du, PhD and CEO of Hutchison MediPharma, said initial discussions with the SFDA about approval under Green Channel provisions for clinical trials went very well. Patients with MDS have bone marrow that does not produce a sufficient amount of mature blood cells. It is often called “pre-leukemia” because, in most patients, the disease progresses to leukemia. In Dacogen’s clinical trials, the drug was shown to delay the onset of more acute stages of the disease.

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