LONDON – Efficacy data for Russia’s Sputnik V COVID-19 vaccine held steady at 91.4% in the second interim analysis, conducted after 39 confirmed cases of COVID-19 infection in 18,794 volunteers, seven days after they received the second dose.
PERTH, Australia – Immutep Ltd. completed a AU$29.6 million (US$21.72 million) placement that will allow the immunotherapy company to accelerate and broaden clinical development of its immuno-oncology and autoimmune programs. Read More
HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints. Read More
SHENZHEN – While China is rather new in biotech innovation and still has potential for growth, industry insiders worry about the long-term sustainability of innovation. Speaking at a recent conference in the southern Chinese city of Shenzhen, various experts said sustaining innovation may depend on differentiation, globalization and reimbursement policies. Read More
SHENZHEN – To accelerate the development of cell therapies, China’s NMPA has introduced a dual-track regulatory pathway that allows companies to seek an IND with data from investigator-initiated trials. Read More
A new report on the biopharma industry by cybersecurity firm Bluevoyant LLC found that the eight most prominent players in the race for a COVID-19 vaccine faced the highest volume of targeted, malicious cyberattacks, and 77% of the total 20 companies examined had unsecured remote desktop protocol (RDP) ports and email domains lacking basic measures to block hackers. “COVID-19 vaccines are the crown jewels of 2020 – and cyber attackers know it,” the report says. Read More
LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222. Significantly, efficacy increased to 90% in the prime-boost arm of the trial, in which volunteers received half a dose, followed by a full dose. In addition to greater protection, that will make supplies go further. Read More
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion. Read More
HONG KONG – Hutchison China Meditech Ltd. (also known as Chi-Med) has received a $100 million equity investment from the Canada Pension Plan Investment Board, which will fund ongoing research, clinical development and commercialization capabilities. Read More
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease. Read More
HONG KONG – D3 Bio Inc. is the new kid on the biopharma block in Shanghai, kicking off with a $200 million series A financing backed by some of Asia’s most prominent venture capital firms. Read More
HONG KONG – Shanghai and New Jersey-based Lianbio has landed a commitment of up to $70 million in non-dilutive capital from a new collaboration with Pfizer Inc., just weeks raising $310 million in an oversubscribed crossover financing round. Read More
HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks. Read More
HONG KONG – Taiho Pharmaceutical Co. Ltd. has signed an exclusive license agreement with Lung Therapeutics Inc., picking up the Japanese rights to Lung Tx’s LTI-01. Read More
PERTH, Australia – As the idea of going to Mars starts to look less far-fetched, scientists are beginning to ask practical questions about how space affects the stability of drugs. Read More
Biopharmas in Asia-Pacific raising money in public or private financings, including: CASI, D3 Bio, Emergex Vaccines, Hutchison China Meditech, Immutep, Juventas Cell Therapy, Oragenics, Qiming Venture Partners, Verona. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Amgen, Arca, Ascentage, Beigene, Biogen, Biontech, Cytodyn, Eli Lilly, Gilead Sciences, Innovent Biologics, Inovio, Janssen Cilag, Moderna, Pfizer, Redhill, Regeneron, Samsung Bioepis. Read More
