Parenteral Biotech Ltd., a subsidiary of Parenteral Drugs (India), Ltd will launch Sinovac’s seasonal influenza vaccine Anflu and H1N1 vaccine Panflu.1 in India.
Sinovac Biotech Ltd, a leading China-based vaccine manufacturer, has entered into exclusive license, supply and distribution agreements with Parenteral Drugs, the companies announced in a press release.
As per the agreement, Parenteral is authorized to register, supply and distribute Sinovac’s Anflu (seasonal influenza vaccine) and Panflu 1 (H1N1 vaccine) to the government of India and private market in India.
Currently, Parenteral Biotech is involved in the registration process is ongoing in India.
Parenteral intends to apply to the Drug Controller General of India (DCGI) for the import approval for the vaccines.
The volume, delivery schedule and other specific details about how Sinovac’s vaccines may be marketed and supplied to the government of India and the private market in India have not been determined.
“The agreements correspond with Sinovac’s international marketing strategy to partner with established local suppliers to secure regulatory approval and more efficiently facilitate distribution in numerous international markets,” stated Weidong Yin, chairman, president and CEO of Sinovac.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases.
Sinovac’s commercialized vaccine products include Healive (hepatitis A), Bilive (combined hepatitis A and B), Anflu (seasonal influenza), Panflu (pandemic influenza (H5N1)), and PANFLU.1 (pandemic influenza A (H1N1)).
Chinese firm Sinovac Biotech Co has claimed that Panflu is a single shot vaccine against the swine-flu causing H1N1 Influenza A strain virus.
Sinovac has tested the vaccine shots in 1,614 volunteers and found that the vaccine is safe and protects people against the pandemic virus after a single shot, the company claimed.
Sinovac’s seasonal influenza vaccine Panflu was released by China SFDA and commercially launched at the end of July 2009.
In June 2009, the Beijing municipal government made its first purchase of its H1N5 vaccine Panflu from Sinovac, with an initial order of four million doses that are expected to be delivered by the end of September 2009.
Sinovac expects more orders in October, taking the total to 10 million doses, reports said.
Sinovac began the clinical trials of its one-shot H1N1 vaccine on July 22, 2009. The volunteers included 101 elders, 706 adults, 404 juvenile and 403 children. All 1614 volunteers had received the first shot of the vaccine through July 25.
None of the volunteers participating in Sinovac’s clinical tests exhibited any sign of severe adverse reactions, during the three-day observation period. Total adverse event rate is 11.8%, which is similar to that of seasonal influenza vaccine. The adverse events were all mild and transient. The most severe symptom was pain at the site of injection, Sinovac said in a companyrelease.
Panflu’s clinical trial was organized by China’s Center for Disease Control (CDC), and undertaken by Beijing CDC. The Ministry of Health (MOH) and State Food and Drug Administration (SFDA) were paying close attention to this clinical trial. Deputy Director General of MOH Disease Control Department, Director of SFDA Registration Section, and other relevant experts visited the clinical trial site to observe the clinical trial.
Sinovac is developing vaccines for enterovirus 71, universal pandemic influenza, pneumococcal infection, Japanese encephalitis, and human rabies.
Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.
Parenteral Drugs (India), Ltd develops, manufactures and markets products, from more than 30 core technologies and across some 40-plus product divisions. The company operations in over 60 countries, and sales in more than 200.