publication date: Dec 9, 2017
author/source: Richard Daverman, PhD
Deals and Financings
Pfizer (NYSE: PFE) signed a $226 million agreement for China/Asian rights to Cresemba® (isavuconazole), an antifungal drug developed by Swiss pharma Basilea (SIX: BSLN) (see story). Previously, Pfizer acquired rights for Cresemba in Europe, Russia, Turkey and Israel. In the latest deal, Pfizer in-licensed rights for China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. Isavuconazole is an antifungal aimed at life-threatening invasive mold infections. Pfizer will develop, manufacture and commercialize isavuconazole in China and the Asia Pacific region.
Everest Medicines announced a $224 million partnership with San Diego's Arena Pharma (NSDQ: ARNA) to develop two Arena small molecule candidates in China and southeast Asia (see story). Both candidates are in US clinical trials. Ralinepag is aimed at pulmonary arterial hypertension, and etrasimod is being tested in autoimmune diseases. Everest is a new company, dedicated to bringing innovative western drugs to China and backed with $50 million in an initial financing led by China's C-Bridge Capital. C-Bridge describes Everest as its incubator platform for bringing novel drugs to China.
Genova Biotech of Changzhou raised $50 million in a funding led by Tasly Pharma (see story). Genova is developing state-of-the-art diabetes products which it expects to offer at prices below global diabetes providers. Founded in 2014, the company has in-licensed rights to four products, though no details on the transactions are available. Genova is a JV formed by China investor BVCF and Changzhou Life Sciences & Healthcare Construction and Development. With the latest funding, Genova has raised $200 million in capital.
Etong Healthcare of Shanghai, a third-party health examination company, announced a $30 Million Series B funding, led by Vision Plus Capital of Hangzhou (see story). Previously, Etong focused on offering healthcare services to businesses. Now, it wants to build its customer-based operations, offering "customized" check-up opportunities to individuals. Etong has three divisions: one platform connects patients with hospitals to book physical checkups; a second connects patients with overseas checkups; and a third connects patients with doctors online.
MicuRx Pharma, a San Francisco-Shanghai company, closed a $15 million financing, which it will use to complete a China Phase III trial of its oral antibiotic, contezolid (MRX-I) (see story). MicuRx expects the trial will finish in 2018. Contezolid treats serious infections caused by Gram positive bacteria, including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant Enterococci (VRE) without causing myelosuppression. The funding was led by China affiliates of Delian Capital and BVCF, both of whom are existing MicuRx investors.
Esaote S.p.A., an Italian medical imaging company, was acquired by a group of China investors (see story). The China syndicate was headed by Yunfeng Capital, Alibaba's (NYSE: BABA) investment arm, and joined by several China medical device makers and investment firms. The price was not disclosed. Esaote will continue as a standalone company headed by its current CEO, Karl-Heinz Lumpi. The China investors intend to introduce Esaote's products -- Ultrasound and MRI scanners, together with associated IT -- to the China market. The company produced $317 million of revenue in 2016.
Shenzhen BioScien in-licensed greater China rights to an immunotherapeutic vaccine for prostate cancer from Generex Biotech (OTCQB: GNBT) of the US in a $5 million agreement (see story). In a Phase I trial, conducted by Generex's subsidiary Antigen Express, AE37 produced an activation of T cells in patients with prostate cancer. Generex said the activation was robust, long-term, and specific. BioScien will develop the drug for mainland China plus Taiwan, Hong Kong and Macau.
Shenzhen's BGI Genomics (SHZ: 300676) has formed a partnership with California's Sanguine BioSciences, a company that links patients with clinical trials (see story). Using BGI's sequencing machines, Sanguine will develop a database that combines genomic and clinical data to recruit patients for clinical trials of precision medicines. The partnership's first project will build a searchable whole-genome and electronic medical record database of more than 1000 patients with rheumatoid arthritis.
WuXi Biologics (HK: 2269) has completed construction of its $150 million 30,000 liter biomanufacturing facility in China (see story). The CRO/CMO initially announced it would build the facility in April 2015. Completed in two stages, the plant has begun operating fourteen 2,000 liter disposable bioreactors for fed-batch cell culture in the facility, the second construction phase, greatly expanding Phase I capacity, which consisted of two 1000 liter disposable bioreactors. WuXi Biologics' plant, located in Wuxi city offers cGMP contract manufacturing services for biologic drugs to WuXi clients.
Johnson & Johnson Innovation (NYSE: JNJ) plans to open a JLABS life science incubator in Shanghai's Zhangjiang Hi-Tech Park, with space for 50 startup companies (see story). The 47,000 square foot facility, the first JLABS site located outside North America, will be operational in Q2 2019. J&J said JLABS @ Shanghai will seek innovative companies from the entire healthcare spectrum, including pharmaceuticals, medical devices and consumer products. JLABS says its "no strings attached" model offers resident innovators a capital efficient and flexible platform for developing products.
Trials and Approvals
Bristol-Myers Squibb (NYSE: BMY) put an early stop to its China Phase III trial of Opdivo (nivolumab), because of positive results (see story). Opdivo is a PD-1 inhibitor and was being tested as a second-line treatment for non-small cell lung cancer. The trial's data monitoring committee determined Opdivo was superior to docetaxel. Using results from the trial, BMS submitted a BLA to the CFDA for Opdivo, and, according to BMS, Opdivo is the first immuno-oncology therapy for second-line NSCLC to be accepted for review in China. http://www.chinabiotoday.com/articles/BMS-China-Trial-Opdivo
Xynomic Pharma, a China-US oncology pharma, will start a Phase I/II trial of its lead candidate, the novel HDAC inhibitor Abexinostat, in combination with Janssen Pharma's Imbruvica® (ibrutinib) (see story). Imbruvica is a first-in-class BTK inhibitor that quickly acquired blockbuster sales in several hard-to-treat cancer types. The trial will be conducted at New York City's Memorial Sloan Kettering Cancer Center in patients with diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).
BeyondSpring (NSDQ: BYSI) announced that China has designated Plinabulin a 2017 National Science and Technology Major Project (see story). The designation implies speeded-up regulatory review and priority approval status in China. Plinabulin is currently being tested in a global Phase III clinical trial (with a large China arm) in patients with non-small cell lung cancer (NSCLC) and Phase II/III clinical program to prevent chemotherapy-induced neutropenia (CIN). BeyondSpring is a virtual company headquartered in New York City and a strong connection to China.