Deals and Financings
Luye Medical, the healthcare arm of Luye Life Sciences, is considering an IPO in Singapore that could raise as much as $500 million (see story). The company has assembled a portfolio of businesses, largely through M&A, consisting of hospitals, clinics and diagnostic services that spreads across China, Australia and Singapore. It is based in Singapore. Luye Pharma (HK: 2186), which is also part of Luye Life Sciences, is the parent's listed pharmaceutical subsidiary.
ARMO BioSciences (NSDQ: ARMO), a Bay Area immuno-oncology company, completed a $128 million IPO on the Nasdaq exchange (see story). The shares rose 75% on the first day to close at $29.74. In its Series C-1 funding, completed in August 2017, ARMO raised $67 million led by China investor Qiming Ventures, and joined by new China investors Decheng Capital, Sequoia Capital, Quan Capital and RTW Investments. ARMO's lead molecule is AM0010, a pegylated form of Interleukin-10, which is currently in Phase III trials as an adjunct to FOLFOX and in Phase I trials as a single agent.
Tmunity Therapeutics, a Philadelphia biopharma developing next-gen immuno-oncology drugs, closed a $100 million Series A round that included Ping An as its first-named investor (see story). Using technology developed at the University of Pennsylvania, Tmunity is developing a broad-based portfolio of T cell therapies for oncology, infectious diseases and autoimmune diseases. Tmunity’s portfolio produces engineered T cells that activate or suppress immunity. Its approaches include T cell receptors, regulatory T cells, Crispr-Cas9 gene editing, allogeneic T cells and bionic T cells, as well as CAR-T programs.
Neuspera Medical, a California neuromodulation company, completed the initial closing of a $26 million Series B round, led by 6 Dimensions Capital (see story). 6 Dimensions was formed in 2017 by the merger of two China-US healthcare investors, Frontline BioVentures and WuXi Healthcare Ventures. Neuspera engineers miniaturized neuromodulation devices using both licensed and proprietary power transfer technologies. Neuspera's implanted modules are as much as 100 times smaller than its competition, the company says.
XtalPi of Boston and Shenzhen closed a $15 million Series B funding led by Sequoia China, with participation from Google's (NSDQ: GOOG) venture arm and existing investor Tencent (HK: 0700) (see story). XtalPi combines artificial intelligence, quantum physics, and high-performance cloud computing to aid in drug design. The company believes its proprietary algorithms can predict important characteristics of small molecule drug candidates, saving development time. So far, XtalPi has raised over $20 million.
China’s Shanghai Pharma (SHA: 601607; HK: 2607) wants to expand its business through M&A, with an eye to overseas transactions, according to the South China Morning Post (see story). Shanghai Pharma is a familiar M&A participant. Recently, however, its thinking has evolved: it is planning to open an office in San Diego sometime in 2018 to spearhead the initiative, and it is thinking partnerships rather than takeovers, partly because of pressure from China and US regulators.
Taiwan Liposome (TT: 4152) will form a joint venture with Jixi Biotechnology to market Taiwan Liposome's products in China (see story). JiXi will make an investment of "millions of dollars" in a Hong Kong subsidiary of Taiwan Liposome in exchange for a minority stake in the company. Taiwan Liposome said it would use Jixi Biotech's experience and resources in mainland China to promote and sell their drugs more efficiently.
Harbour BioMed of Shanghai completed a Series A+ round of unspecified size (see story). The funding was led by CDH Investments, a China PE firm, and joined by existing investor Advantech Capital. In late 2016, Harbour was formed with $50 million in initial capital. At the same time, it acquired Harbour Antibodies BV, a Rotterdam company with two proprietary transgenic mouse platforms. The company plans to develop immuno-oncology and immunology antibodies. http://www.chinabiotoday.com/articles/Harbour-Raises-Additional-Capital
Trials and Approvals
Generon (Shanghai) reported its recombinant biologic for chemotherapy-induced neutropenia met its primary efficacy endpoint in a China trial that enrolled patients with breast cancer (see story). F-627 (Benegrastim/BineutaTM) is a second-gen human granulocyte colony-stimulating factor (rhG-CSF) dimer that Generon believes has best-in-class potential. The primary endpoint was the duration of grade 4 (severe) neutropenia in the first chemotherapy cycle.
Amoy Diagnostics (SHZ: 300685) of Xiamen received CFDA approval for its plasma-based EGFR test (see story). The Super-ARMS® EGFR Mutation Test is a companion diagnostic for EGFR-based inhibitors such as Iressa and Tarceva. The test, the first plasma-based EGFR diagnostic available in China, is indicated for use when a tumor biopsy for a patient is not available. Last year, AmoyDx's EGFR diagnostic was approved for use in the EU.
Chengdu's Clover Biopharma announced plans to build a biologic drug manufacturing facility in Changxing, Zhejiang Province (see story). The facility, which will have two 2000-L bioreactors, will be built around GE Healthcare’s FlexFactory single-use technology. Clover will use the plant for its biological fusion protein products, including both innovative drugs and biosimilars. Last month, Clover received CFDA permission to begin China trials of its Enbrel biosimilar for rheumatoid arthritis. The company also raised $9.5 million in a Series A funding recently.
GlaxoSmithKline (NYSE: GSK) launched Triumeq, a triple-therapy antiretroviral treatment for HIV, in China at a monthly price of $450 (see story). That price is lower than in South Korea, Taiwan and Hong Kong, GSK said. It is also an 85% discount to the usual price of $2900/month in the US. In China, Triumeq is distributed by ViiV Healthcare, a JV majority owned by GSK along with minority shareholders Pfizer (NYSE: PFE) and Japan’s Shionogi.
Government and Regulatory
China researchers have treated 86 cancer patients with genetically modified versions of their own immune cells (see story). Using Crispr-Cas9 tools, the scientists have removed a small section of the patients' T-cell DNA that prevents the immune cells from destroying cancer. There are no similar trials in the US because, according to a Wall Street Journal article (see story), the regulatory systems are so different in the two countries. Until a year ago, China treated cell and gene therapies, particularly autologous cell therapies, as natural substances. Now they are considered drugs and reviewed by the CFDA, which ChinaBio® believes will align China and US regulations more closely.