China's National Health and Family Planning Commission (NHFPC) will invest $3.2 billion in R&D projects for new drugs that target ten major diseases. The effort is to take place during the 12th Five-Year Plan, which ends in 2015, leaving less than two years to make the investments. The diseases include cancer, cardiovascular and cerebrovascular diseases, neurodegenerative disorder, mental disorders, diabetes, autoimmune disease, drug-resistant pathogen infection, tuberculosis and other common diseases.
To speed up approval of innovative medical devices, the CFDA has set up a special office at the Center for Medical Device Evaluation. The division will decide whether a specific device qualifies as innovative. If it does, the same group will supervise the approval process under priority procedures. Both foreign and domestic companies are eligible for the program. The priority review is expected to shorten the entire approval process to about 160 days. Under the old system, it was a year or more.
The CFDA has begun a five-month campaign to root out unsafe medical products in China. The effort will target a wide range of possible problems, ranging from counterfeit products, to medical equipment that is not sterile, to websites promoting useless products, to complex medical devices whose clinical trial data may have been compromised. The increased oversight is a precursor to more thorough regulatory reform. Soon, China's State Council will issue a revision of the Regulations on Medical Instrument Management, which will put new long-term rules in place for monitoring the safety of medical devices.
Sagent Pharma (NSDQ: SGNT) will invest $30 million to build a second production line at its China production plant (see story). At full capacity, the Chengdu facility will be able to supply 25% of its annual product needs. In general, Sagent uses partners to produce its portfolio of injectables products, but it spent $25 million last year to buy out its China JV partner and bring the Chengdu operation entirely in-house, the only production facility Sagent owns.
On Monday, March 24, Qiagen (NSDQ: QGEN) will celebrate World TB Day by staging the China launch of QuantiFERON-TB Gold In-Tube, its TB diagnostic blood test (see story). Qiagen says its test is more accurate than the traditional skin test for TB, which is known to give false positives. Qiagen, a Dutch maker of samples and assays, expects China to become one of its major markets for the test.
Simulations Plus (NSDQ: SLP) of California signed up the Research Institute for Liver Diseases, located in Shanghai, to distribute its pharmaceutical discovery/development simulation and modeling software in China (see story). Simulations calls its products "in silico consulting services" and positions them as a natural fit for RILD's in vitro experimental systems.
Trials and Approvals
Hua Medicine of Shanghai announced it will start a Phase Ib trial of its glucokinase activator (GKA) treatment for type 2 diabetes. In the Phase Ia trial, HMS5552 produced positive results in healthy volunteers. Because of the excellent early results, Hua thinks HMS5552 may be a best-in-class candidate. The Phase Ib trial will test the drug in type 2 diabetics. Hua, which in-licensed the second generation GKA drug from Roche (OTCQX:RHHBY), holds global rights to HMS5552.