FiercePharmaAsia—Amgen’s China biosim deal, Sovaldi’s Chinese nod, Shanghai Pharma’s Alvogen talks

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Amgen, Simcere, Shanghai Pharma and Gilead Sciences made the news this week.

Welcome to this week's FiercePharmaAsia report, which includes stories about a biosimilar development deal Amgen inked with Simcere, Gilead's Chinese nod for Sovaldi, a potential sale of Alvogen's U.S. business to Shanghai Pharma, and more.

1. Amgen targets China in cancer biosimilar development deal with Simcere

Amgen is trying to sell four of its biosimilars in oncology and inflammation in China, and it has inked a co-development deal with local specialist Simcere. Amgen said the meds will come from its existing pipeline, which includes copycats to some blockbuster meds like AbbVie’s Humira, Roche’s Avastin, Herceptin and Rituxan, and Janssen’s Remicade.

2. Gilead nabs Chinese nod for Sovaldi, eyeing world's largest hepatitis C patient base

China’s FDA has approved Gilead’s hepatitis C med Sovaldi months after it approved the country’s first direct-acting antiviral agents in the form of Bristol-Myers Squibb’s dual-drug regimen Daklinza and Sunvepra. The country’s estimated 10 million HCV patient base is far larger than the U.S.’ 3-4 million. Gilead is also examining Harvoni and Epclusa in China for approvals in the near future.

3. CVC talks $4B Alvogen sale with Shanghai after just 2 years of ownership

Just two years after nabbing a majority stake in Alvogen, CVC Capital Partners and others are said to be weighing their options to sell the New Jersey drugmaker’s U.S. business to Shanghai Pharma. For Shanghai Pharma, the buy would be a boost after its failed attempt at Stada. It's also bidding alongside Fosun Pharma for a stake in Arbor Pharma.

4. Boost for Exelixis as partner Daiichi Sankyo cues up hypertension drug filing

In a big step forward for Daiichi Sankyo’s longtime partnership with Exelixis, the pair’s essential hypertension therapy esaxerenone met its primary endpoint of matching eplerenone in lowering blood pressure in a phase 3 study. The Japanese drugmaker now plans to file for approval in its home market next year, while has also started phase 3 trials of the drug in diabetic nephropathy.

5. AstraZeneca's latest respiratory win could spur Bevespi approvals in China, Japan

In a phase 3 trial, AstraZeneca’s Bevespi Aerosphere—a combination of glycopyrronium and formoterol fumarate—outperformed the individual components at improving lung function. Now the company is planning to file this LAMA/LABA combo COPD med for approvals in China and Japan next year. With Symbicort and likely newcomer Duaklir, AZ is also fighting compatriot GlaxoSmithKline in the same field.  

6. Serum Institute touts phase 3 rotavirus data as it preps first deliveries

In a large-scale phase 3 study, Serum Institute of India’s heat-stable rotavirus vaccine, Rotasiil, reduced severe rotavirus diarrhea in infants by 39.5% over two years. Partnered with nonprofit PATH, the company is now aiming for WHO prequalification designation, challenging GSK’s Rotarix and Merck’s RotaTeq, both of which need to be refrigerated. India’s government has ordered 3.8 million doses of Rotasiil.

7. Sinovac’s chickenpox vaccine shows 87% efficacy in topline phase 3

Preliminary phase 3 data showed that Sinovac’s pediatric chickenpox vaccine was 87.1% effective against the viral infection. The company is now planning for commercialization in China by the end of 2019. The only Nasdaq-listed Chinese vaccine maker, Sinovac is slated to go private, but the process has been full of drama.

8. Chinese drugmaker gets FDA warning over false test results, barring access

The FDA found Shandong Vianor Biotech falsified test results, and during a May inspection, company officials prevented an investigator from entering a room identified as a laboratory. Later, when allowed to enter the room, the investigator found there was no equipment. The company was served with a warning letter and placed on an import alert.