Welcome to this week’s FiercePharmaAsia report, which includes stories about Novartis CEO's prediction for China pharma market growth, Hanmi's failure to disclose olmutinib cancer trial side effect, Celgene's first Asia-Pacific partnership, Ionis' China RNA drug development deal and more.
China is already the second largest pharma market in the world, but as drugmakers face growth challenges in the U.S. and other developed countries, the country is looking more enticing to Novartis chief Joe Jimenez, who expects it to surpass $300 billion by 2020. China is also making changes to offer new drugs more quickly and at lower prices to patients.
A patient died in a test of Hanmi’s lung cancer med olmutinib in 2015, but the person in charge did not immediately report the side effect to South Korea’s authority. It has broken two medical laws in that sense, but Hanmi argues that it originally thought the case wasn't related to its own med, only to discover otherwise after it went through the monitoring of data for its trials.
Celgene has tapped its first partner in the Asia-Pacific region: China-based Antengene. The first step is a licensing deal to develop its TORC1/2 inhibitor CC-223 in the area with a second one on the horizon, and CRO Tigermed will help the young Chinese biotech with clinical development. Celgene will obtain an equity position in Antengene, in addition to a place on its board of directors.
Ionis has enlisted the help of Suzhou Ribo Life Science to help it bring two second-generation antisense drugs—targeting metabolic disease and cancer—as well as an option on a third candidate to the Chinese market. It said the Chinese biotech is an “ideal partner” to Ionis, given its own focus on RNAi-based drugs and local drug development and regulatory expertise.
Japan’s Fujifilm believes its CDMO operation can grow exponentially by focusing on biologic drug manufacturing. To reach $1 billion in biologics contract work by 2023, it has completed a $93 million Texas manufacturing facility, funded in part by HHS’ BARDA, and said it will invest another $23 million to expand that operation. Another $9 million will be spent on its facilities in Billingham, U.K.
Swedish CDMO Recipharm made several acquisitions last year, including a 74% stake in India’s Nitin Lifesciences for $102 million, and India’s Kemwell, which gave Recipharm its first operation in the U.S., for $120 million. With a growing global footprint, the company believes it could take advantage of what is expected to be more consolidation and growth in the CDMO market.
The FDA issued Aurobindo Pharma a Form 483, citing six observations related to procedural improvements at the company’s Unit III facility at Bachupally in Hyderabad, India. The plant manufactures oral formulations that include antiretroviral drugs.