China FDA HIV treatment nods for Xian Janssen, GSK show going local helps

China FDA has approved two HIV therapies that show the combination of local partners and high unmet need might be a winning one for reaching the market quicker.

Approvals in the past month for Tivicay from GlaxoSmithKline's ($GSK) joint venture partner ViiV Healthcare, and Complera for local pharma subsidiary Xian Janssen Pharma, a unit of Johnson & Johnson ($JNJ), highlight the moves by policymakers to focus on disease areas with high unmet need and the potential of help from local companies to speed the process along.

In July, GSK said the API of Tivicay, dolutegravir, will be made in China by Shanghai-based Desano Pharmaceuticals, offering a "competitive supply" for Medicines Patent Pool countries as well as China. Tivicay is indicated for HIV-infected patients who have taken other treatments and in children younger than 12 who have not used integrase inhibitor therapies.

"Tivicay, an innovative HIV drug from ViiV Healthcare, has received approval from the China Food and Drug Administration for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age," GSK said in a Jan. 19 press release. The product came to the joint venture through Japan's Shionogi and was approved in the U.S. in 2013.

Complera was approved in late December, a Xian Janssen spokeswoman said in an emailed statement to FiercePharmaAsia. The treatment was co-developed by J&J and Gilead Sciences ($GILD).

"Xian Janssen can confirm that in December 2015 the China Food and Drug Administration granted regulatory approval for Complera use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy," the emailed statement said. Complera incorporates three antiretroviral medications in a single daily tablet, and is the first complete single-tablet regimen for HIV treatment to be approved in China.

Janssen recently has done deals in China on hepatitis B and a diabetes treatment in South Korea that show the extent of its efforts to work with local firms.

Although the approvals were an essential first step, analysts have stressed the importance of getting the products onto the national reimbursement list for what has been officially recognized as a growing health concern.

In December, a report said that China now counts more than half a million people with HIV/AIDS, citing data from the China CDC, with adolescents particularly at risk. HIV along with cancer were identified last year as diseases that would see potential therapies fast-track reviewed.

That effort to speed such drugs to the market may also bode well for GSK to show its commitment to bringing in new therapies to China as part of a pledge made following a $489 million fine last year for bribing Chinese doctors to buy its drugs.

GSK's Hervé Gisserot

"The approval of Tivicay in China is a significant treatment advance for HIV/AIDS patients in China. We are working tirelessly to launch Tivicay in the Chinese market," Hervé Gisserot, senior vice president and general manager of Pharmaceuticals and Vaccines for China/Hong Kong, said in a statement.

"However, in our view, launching innovative products without providing access to them, is not real innovation. Therefore, GSK's strategy to be in China, with China, for China means we are absolutely committed to making Tivicay accessible to as many patients as possible".

- here's the release from GSK China