Deals and Financings
China's 3SBio (HKEX: 1530) obtained global rights to an anti-TNF mAb for autoimmune disease, including rheumatoid arthritis, which was discovered by Apexigen of the San Francisco area (see story). 3SBio in-licensed China rights to SSS07 in 2006; the new pact extends that agreement to include the rest of the world. 3SBio started a China Phase I trial of the molecule earlier this year. The ex-China rights will allow 3SBio to bring the drug to the lucrative US and European markets. No financial details were disclosed.
Materialise (NSDQ: MTLS), a 3D printing company based in Belgium, agreed to open a multidisciplinary 3D printing center in Fuwai Hospital, a tier three Beijing hospital focused on cardiovascular care (see story). The center will use Materialise's HeartPrint® software and printing equipment to construct 3D models of patients' hearts, based on MRI and CT scans, The models will help surgeons plan their strategy before complex surgeries. Materialise expects Fuwai Hospital will introduce the technology to the rest of China.
Trials and Approvals
Ascletis, a Hangzhou-US clinical stage pharma, reported that China and Taiwan have accepted a clinical trial application to test its dual-drug, interferon-free regimen for chronic hepatitis C (see story). Ascletis is the first China company to achieve this milestone. "There are no direct-acting antiviral agents (DAAs) approved in China, and no China companies have filed to start clinical trials of more than one DAA in China," Dr. Jinzi Wu, Founder, Chairman and CEO of Ascletis, told ChinaBio® Today in an exclusive interview. "We are very competitive against both domestic and multinational pharmas."
BeiGene, a Beijing biopharma focused on cancer therapies, was granted FDA approval to begin US clinical trials of BGB-3111, its proprietary Bruton tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies (see story). In preclinical tests, BGB-3111 showed improved efficacy and a better safety profile than existing BTK inhibitors, said BeiGene. BTK plays a part in B-cell receptor signaling, which is significant for B-cell malignancies such as various forms of leukemia.
PharmaEngine (TWO: 4162) of Taiwan reported its pancreatic cancer drug, MM-398, was granted priority review for its US NDA, reducing review time from ten months to six (see story). The filing was made by Merrimack Pharma (NSDQ: MACK), PharmaEngine's US licensee. Its European partner, Baxalta, a subsidiary of Baxter (NYSE: BAX), said the filing for approval of MM-398 was accepted by the EMA, triggering an $11 million payment to PharmaEngine. MM-398 (irinotecan liposome injection (nal-IRI)) is indicated for cancer of the pancreas in patients who have failed a gemcitabine treatment. In Taiwan, PharmaEngine's filing for approval of the drug was accepted earlier this month.
SGS Life Science Services, a global microbiology testing service headquartered in Switzerland, will expand its Shanghai cGMP chemistry and biotechnology testing lab (see story). One year ago, the company announced it would add on to its lab, but SGS says increased demand for services now means a follow-up expansion. In 2014, the lab employed 74; that has grown to 120; and SGS expects it to hit 135 by year-end 2015. As part of the growth, SGS will add an active compound lab to test antibodies and hormones.
source: ChinaBio® Today. Copyright ©
ChinaBio® LLC. Redistributed with permisssion. All rights reserved.