Deals and Financings
Asymchem Laboratories (Tianjin) (SHZ: OO2821) completed a $125 million IPO in Shenzhen. Asymchem is contract manufacturer of APIs, cGMP intermediates and finished drugs, all from its manufacturing facilities in China. Most of the proceeds will be used to build its R&D facilities and additional manufacturing facilities in Tianjin, which is also the company's headquarters.
BeyondSpring Pharma, a virtual US-China company, filed to stage a $100 million IPO on the NASDAQ exchange. The company's business plan calls for integrating US and China clinical resources, making adept use of both to reduce cost and time. The company focuses on cancer-related therapies and plans to market them in the US and China. BeyondSpring will advance plinabulin as a treatment for neutropenia, and it is also testing the molecule, alone and as an adjunct to existing therapies, as a direct acting therapeutic for several forms of cancer.
SciClone Pharmaceuticals (NASDAQ:SCLN), a San Francisco-area company that markets drugs in China, received an unsolicited $570 million acquisition offer. The offering group, which does not seem to include SciClone's management, is GL Capital Management GP Limited and ABG Management Limited. Both entities are allied with Ally Bridge Group, a Hong Kong-based VC/PE firm. The investor consortium offered $11.18 per share to acquire SciClone, which was 13% higher than the previous day's closing price. SciClone's management did not embrace the offer and didn't comment, except to say it would consider the offer carefully, pointing out that the consideration was their duty.
Uni-Bio Science (HK: 0690) of Hong Kong and Luqa Pharma, a China dermatology and aesthetics company, formed a partnership to co-market their respective dermatology drugs/devices in China. The three-year agreement includes currently approved and future dermatology products. Both companies market wound healing treatments in China, and both have existing marketing teams. Uni-Bio promotes GeneSoft, an in-licensed ophthalmic wound healing product, in China, and Luqa is responsible for marketing Stratpharma's Strataderm to treat scars and Laluxid for wound healing.
Omixon, a Budapest molecular diagnostics company, partnered with Taiwan's TBG Biotechnology to distribute and promote Omixon's Holotype HLA products in China, Hong Kong, Taiwan and Australia. Omixon's Holotype HLA genotyping products are used to assess transplantation compatability. TBG and Omixon have optimized Holotype HLA on TBG's liquid handling DX-A Automation System, and the companies are completing a multi-site customer validation program of the liquid handling system.
Trials and Approvals
A team led by Lu You, an oncologist at Chengdu's Sichuan University, became the first to inject CRISPR-Cas9 edited genes into a patient. The patient has metastatic non-small cell lung cancer. The team extracted immune cells from the unnamed person, used CRISPR-Cas9 editing tools to delete the PD-1 immune system checkpoint, expanded the edited cells and injected them back into the patient. The ten-patient trial will administer two, three and four rounds of the treatment, with safety being the primary endpoint, though everyone will be equally interested in any signs of efficacy.
Athenex, a US-China pharma, will collaborate with Eli Lilly (NYSE:LLY) in a two-drug clinical trial for patients with advanced gastric and esophageal cancer. Athenex will contribute oraxol, its oral form of paclitaxel, and Lilly will add CYRAMZA, a vascular endothelial growth factor (VEGF) Receptor 2 antagonist. The Phase Ib trial, which will start in early 2017, will be conducted in the US and Asia. Athenex is building two manufacturing plants in Chongqing.
Hutchison China Meditech (Chi-Med) (NASDAQ:HCM) reported positive data from a first-in-human Phase I trial of HMPL-523, a Syk inhibitor. Syk helps to regulate downstream signaling in immune receptors, including B cell receptors. Chi-Med expects to test the candidate as a treatment for rheumatoid arthritis and B-cell malignancies. In healthy volunteers, the Phase I trial of HMPL-523 showed the molecule was generally well-tolerated and suppressed B-cell activation in a dose-dependent manner.
ASLAN Pharma of Singapore engaged JHL Biotech, a Taiwan/China CMO, to provide biologic process development services and clinical trial supplies of ASLAN004. ASLAN004 is a fully human monoclonal antibody that blocks the signaling of the IL-4 and IL-13 receptors. Work will start in 2016 in JHL's GMP-certified facility in Zhubei, Taiwan. ASLAN secured worldwide rights to ASLAN004 from CSL Behring in 2014, originally for asthma, though it is also developing the molecule to treat cancer.
NeuroMetrix (NASDAQ:NURO), a US medical device maker, announced it will begin the China launch of DPNCheck, a diagnostic test for peripheral neuropathy. The device was approved by the CFDA in January. A Class II Medical Device, DPNCheck measures sural nerve conduction velocity in the leg, a biomarker for peripheral neuropathy. The device will be introduced at the 20th Scientific Meeting of the Chinese Diabetes Society during November 16-19, 2016 in Xiamen, Fujian. Omron Beijing will market the device for NeuroMetrix in China.
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