Following a record-shattering year, terms were set for the first two biotech IPOs of 2021 in deals that could generate up to $300 million. Cullinan Oncology LLC, of Cambridge, Mass., set terms Jan. 4 for raising about $150 million by pricing 8.3 million shares in the $17 to $19 range. Read More

HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) earned approval from China’s National Medical Products Administration (NMPA) for Sulanda (surufatinib) for the treatment of non-pancreatic neuroendocrine tumors (NETs). Read More

Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions. Read More

NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). Read More

HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion. Read More

HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Read More

It has been a year since Wuhan health authorities first issued a bulletin about a cluster of pneumonia cases of unknown cause, first bringing what would become the COVID-19 pandemic to the attention of the World Health Organization. Now, a mutation that significantly increases SARS-CoV-2’s transmissibility has been detected in the U.S.  Read More

Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision. Read More

PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure. Read More

Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Advaccine Biopharmaceuticals Suzhou, Arcturus, Azurrx, Biontech, Brand Institute, Epivax, First Wave, Generex, Global Cancer Technology, Innovare R&D, Inovio, Moderna, Nugenerex Immuno-Oncology, Pfizer, Pluristem, Propanc, Shanghai Junshi, Vaxil. Read More

Biopharmas in Asia-Pacific raising money in public or private financings, including: Aivita Biomedical, Arch, Eyepoint, Immvira, Ocumension, Oragenics, Taiwan Liposome, Tracon. Read More

Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Arcturus, Direct Biologics, Emergent Biosolutions, Kaleido, Neurorx, Nicox, Ocumension, Redhill, Regeneron, Relief, Sinopharm, Tiziana Life Sciences. Read More

Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Antengene, Arcturus, Astrazeneca, Biocure Technology, Capricor, Celltrion, Hutchison China Meditech, Pharos Vaccine, Tracon. Read More