China pushes on with vaccine efforts, with 16 candidates approved for trials
HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.

China pushes on with vaccine efforts, with 16 candidates approved for trials
HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.
Clover bags $230M in series C, moves COVID-19 vaccine to phase II/III
Chengdu-based Sichuan Clover Biopharmaceuticals Inc., known for its Trimer-Tag technology, raised $230 million in a series C financing round. The proceeds will, most notably, help it advance its COVID-19 vaccine candidate, S-Trimer (SCB-2019), to a global phase II/III trial by June. Following its $43 million series B round in December 2019, Clover said on Tuesday, Feb. 23, that it raised more than $400 million in the last 12 months. The company uses its Trimer-Tag technology platform to produce covalently-trimerized fusion proteins to develop protein-based vaccines and biologic cancer therapies.
COVID-19 vaccine counterfeits set off alarms across the globe
CAJICA, Colombia – A cooler box with 70 vials allegedly filled with counterfeit COVID-19 vaccines seized from a Chinese couple in Colombia’s El Dorado International Airport on Feb. 17 underscored the growing challenges facing pharmaceutical companies, law enforcement authorities and health care regulators around the world. Patient safety, company liability, and the security of distribution channels have all been areas of growing concern.
Australian researchers identify potential treatment for fatal brain cancer in children
PERTH, Australia – The fight against diffuse intrinsic pontine glioma may finally see some progress, after experiments using 3D models of the tumor in animal studies showed that a combination therapy of the polyamine inhibitor AMXT-1501 (Aminex Therapeutics Inc.) and the ornithine decarboxylase 1 inhibitor difluoromethylornithine could eradicate cancer cells.
Beigene strikes its second overseas deal this year with BITT for TNFR2 antibodies
HONG KONG – Beijing-based Beigene Ltd. struck its second deal outside China this year, signing an option and license agreement with Boston Immune Technologies & Therapeutics Inc. (BITT) for the latter’s tumor necrosis factor receptor 2 (TNFR2) antagonist antibodies. Beigene will exclusively develop, manufacture and commercialize BITT’s TNFR2 antagonist antibodies in Asia, excepting Japan, Australia and New Zealand.
News in brief
BioWorld Asia briefs for Feb. 23.
Awaiting FDA decision on ibrexafungerp, Scynexis deals greater China rights to Hansoh
HONG KONG – Hansoh Pharmaceutical Group Co. Ltd. picked up the greater China rights to Scynexis Inc.’s lead candidate, ibrexafungerp. Under the terms, Hansoh will take charge of the development, regulatory approval and commercialization of the antifungal in the region in exchange for a $10 million up- front payment and as much as $112 million in development and commercial milestones, plus low double-digit royalties on net product sales.
Ferring expands Mybiotics ties with deal for development of microbiota-based BV therapy
HONG KONG – Ferring Pharmaceuticals’ microbiome-focused subsidiary Rebiotix Inc. and Mybiotics Pharma Ltd. have agreed to a multiyear strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis (BV). The companies did not disclose the financials of the deal.

Analysis and data insight

Clinical data drops in recent months, but is way ahead of this time last year
Clinical
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
Still on deck for FDA action, developers continue to wait beyond PDUFAs
Drugs
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
Wanted: A sense of urgency, a roadmap and a global health system to battle future pandemics
Conferences
As the world begins to emerge from a horrific pandemic, it has become abundantly clear that dangerous infections are here to stay, and it is up to health care leaders and citizens to remain prepared and vigilant in preventing another deadly and disruptive COVID-19.
Stakeholder survey: Drug and device companies laud TGA’s pandemic response but want process improvements
Coronavirus
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s...

Financings

Innocare raises $392M, starts phase III of orelabrutinib combo therapy for MCL
Cancer
Chinese cancer and autoimmune specialist Innocare Pharma Ltd. raised HK$3.04 billion ($392 million) in private placements with two Hillhouse Capital subsidiaries and Vivo Opportunity Fund to advance its pipeline, especially its core asset, the BTK inhibitor orelabrutinib.

Australia

Australia establishes COVID-19 vaccine safety monitoring plan ahead of rollout
Regulatory
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.

TGA seeks feedback on impact of proposed fee changes for drugs and devices
Drugs
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
Australia’s TGA grants provisional approval to Astrazeneca’s COVID-19 vaccine
Regulatory
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26...

China

Sinovac COVID-19 vaccine gets approved in China; doors opening elsewhere
Regulatory
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization.
Many unkept promises, but USTR sees progress in China’s trade commitments
Drugs
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters.
Luye’s schizophrenia drug approval in China challenges J&J’s Risperdal Consta
Regulatory
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is...
Ascentage’s New Year’s resolution includes getting its first candidate to market
Clinical
HONG KONG – Tapping into synergies it sees between the U.S. and Chinese biotech industries, Suzhou, China-based Ascentage Pharma Group International is aiming to get its most advanced candidate, HQP-1351, to market this year.
China's CNBG/Sinopharm COVID-19 vaccine is 79% effective
Clinical
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.

Regulatory

FDA grants EUA for Abcellera-Junshi-Lilly COVID-19 treatment
Drugs
Another monoclonal antibody therapy has entered the pandemic fray with the FDA granting emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg and etesevimab (JS016 or LY-CoV016) 1,400 mg as a cocktail for treating mild to moderate COVID-19 in patients aged 12 and up at high risk for...

Newco news

U.S.-China startup Tavotek pursues innovation with early stage cancer, autoimmune R&D
Cancer
Preclinical startup Tavotek Biotherapeutics Ltd., with operations in Pennsylvania and Suzhou, China, boasts two technology platforms for discovering and developing molecular-targeted biologics for cancers and autoimmune diseases and is working to push its candidates, including a bispecific...

Australia’s Chimeric Therapeutics in-licenses scorpion-derived CAR T from City of Hope
Cancer
PERTH, Australia – Chimeric Therapeutics Ltd. has acquired exclusive worldwide rights to develop and commercialize the City of Hope Cancer Center’s chlorotoxin chimeric antigen receptor cell therapy.
After AU$45M IPO, Aroa rakes in two new approvals as it ramps up commercial presence
Regulatory
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.

Science

KRAS drugs may do best in tough subtype
Conferences
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40...
WCLC 2021: KRAS drugs may do best in tough subtype
Conferences
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined.
Trying to stay ahead of SARS-CoV-2 as variants emerge
Europe
LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19...
COVID anniversary coincides with advent of more transmissible variants
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...
Antimicrobial polymers AMP up fight against MDR bacteria
Drug resistance
An international study led by Nanyang Technological University in Singapore has designed and synthesized broad-spectrum antimicrobial polymers (AMPs) and demonstrated the safety and efficacy of two such agents against multidrug-resistant (MDR)...
Linking two liver cancer culprits
China
BioWorld looks at translational medicine, including: Reversal of pumping direction is reversal of fortune for tumor cells; Cholesterol drug affects checkpoint blockade via MHC1; Heart development protein has role in adult immunity.

BioWorld Perspectives

U.S. politicking threatens public trust in the FDA and CDC
BioWorld
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
When it comes to drug quality, is a ‘C’ acceptable?
BioWorld
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the...
A decade of incentives to promote antibiotic development and still no viable route to commercial success
BioWorld
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for...
BioWorld's Top 10: Biggest newsmakers and trending stories of 2018
BioWorld
In many ways, 2018 resembled the previous year in fast motion. Political turmoil accelerated on both sides of the Atlantic, with Asia swept into the fold,...
Deck the halls, or get decked out: BioWorld’s 12th annual Holiday Gift Guide
BioWorld
The holidays are (already) here again. Much as we try to push back the calendar, those Thanksgiving doorbuster, Black Friday blowout, Small Business...
Price increases - tone deaf or defiant?
BioWorld
Defying the laws of nature, many drug companies seem intent on proving that what goes up doesn’t have to come down. For them, the sky’s the limit when it...
PABNAB – A disappointing distraction at BIO, not associated with BIO
BioWorld
On what planet are the PABNAB (Party at BIO not associated with BIO) organizers living to think it was acceptable to spotlight topless dancers with company...

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