Deals and Financings
Nanjing King-Friend Biochemical (NKF) (SHA: 603707) invested $95 million in Meitheal Pharma of Chicago, a generic injectables company, raising its holdings to a majority stake. Meithall distributes NKF products in the US. Founded in 2017, Meitheal has 12 FDA-approved products for anti-infective, oncolytic and intensive care indications. In addition, it has 49 products in R&D, 24 products under review in the US, and eight products planned for 2019 launches. Nanjing King-Friend is known for its heparin-related products, though it has expanded into critical care and oncology.
Shanghai Newsoara BioPharma acquired China rights to a prostate/breast cancer treatment from Zenith Epigenetics, a Canadian company, in a $78 million agreement. ZEN-3694 is a BET inhibitor that is in US Phase II trials to treat metastatic castration-resistant prostate cancer and triple negative breast cancer. Newsoara agreed to pay $15 million in upfront and near-term development milestones plus another $63 million in sales milestones. It will also pay make 6% royalty payments.
Beijing Biocytogen, a CRO that provides gene-modified animal models for biomedical research, closed a $77 million Series D venture funding round. The D round was led by China Life Healthcare Fund and SDIC Venture Capital. Last year, the company raised $65 million in a C round. Founded in 2008, Biocytogen has branches in Beijing, Haimen/Jiangsu, Shanghai and Boston. Bioocytogen generates custom gene-modified animal models/cell lines, breeds and produces animal models, and provides preclinical testing services for immunoncology molecules and therapeutic antibodies.
Ascletis Pharma (HK: 1672) of Hangzhou led a second tranche of a Series E financing for the Bay Area's Sagimet that brings the financing to $25 million. Ascletis, which also led the first tranche, acquired China rights to Sagimet's novel non-alcoholic steatohepatitis (NASH) candidate as part of the deal. In April 2019, Sagimet dosed the first patient in a US-China Phase II trial of the FASN (fatty acid synthase) inhibitor, TVB-2640. Ascletis focuses on viral, cancer and fatty liver diseases with two treatments for hepatitis C approved in China.
Kangpu Bio-Pharma, a Shanghai clinical stage company, completed a $14 million Pre-B financing. Headquartered in Zhangjiang Hi-Tech Park, Kangpu is focused on developing small molecule drugs targeting immuno-modulating sites to develop treatments for cancer, autoimmune diseases and inflammation. The company has developed proprietary technologies to generate and degrade ubiquitin-protein. It also has a drug discovery combination platform called X-Synergy. The financing was led by Shenzhen Guozhong Venture Capital and Shanghai Furong Investment.
PackGene Biotech, a Guangzhou-Boston company that develops viral vectors for gene therapies, completed a venture financing round from Kaitai Capital. The amount was not disclosed. The company offers customized adeno-associated virus (AAV) vector cloning/packaging services based on its unique entry vector portfolio. PackGene uses CRISPR technology to edit AAV vectors, a combination it believes will change the concept of in vivo experiments and animal modeling. It further expects its technology will solve the viral vector production bottleneck by improving the efficiency of the production process.
CStone Pharma (HKEX: 2616), a Suzhou oncology company, signed an agreement with Suzhou Industrial Park to build a 100,000 square meter facility that will house integrated R&D, pilot plant and commercial manufacturing operations. The SIP provided support for the facility, which is expected to break ground in 2020. When completed, the complex will have a production capacity of 26,000L for large molecule biologics and 1 billion tablets and capsules for small molecule drugs. CStone claims to be the only China pharma with all three checkpoint inhibitors - PD-1, PD-L1 and CTLA-4 - in clinical development.
Trials and Approvals
Suzhou's Innovent Biologics (HKEX: 01801) (OTCPK:IVBIY) will collaborate with Beijing Shenogen Pharma to test a combination of Innovent's approved PD-1 drug, Tyvyt, with Shenogen's SNG1005 in patients with advanced cancer. SNG1005 is a conjugate of angiopep-2 and paclitaxel that is designed to cross the blood-brain barrier. Shenogen has been approved to conduct a China Phase II/III trial of SNG1005 in patients with breast cancer carcinoma brain metastases (BCBS). In late 2018, Tyvyt was approved in China to treat classical Hodgkin's lymphoma. Innovent develops biologics for oncology, while Shenogen is a discovery/development pharma.
Eureka Therapeutics, a Bay Area immunotherapy company, began a US Phase I/II clinical trial of its liver cancer T-Cell therapy at the City of Hope Hospital in Los Angeles. Last year, the candidate completed a small proof-of-concept trial among heavily pre-treated liver cancer patients in China that showed early signs of efficacy. ET140202 ARTEMIS includes a propriety antibody that attaches to a protein unique to liver cancer and also features a re-engineered T-Cell that greatly reduces the cytokine release syndrome that plagues most other T-Cell therapies.
Gilead Sciences (NASDAQ:GILD) was granted China approval for its once-daily novel three-in-one oral treatment for HIV. Biktarvy is a combination of a novel, unboosted integrase strand transfer inhibitor (INSTI), bictegravir, with the two-drug treatment Descovy (emtricitabine and tenofovir alafenamide). Biktarvy was approved in the US and EU in 2018. Gilead was not required to conduct specific China tests, but based its filing on four Phase III global studies that enrolled a diverse population of 2,414 HIV-1 infected patients.
Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.