Simcere licenses CDK4/6 inhibitor from G1 Therapeutics in $170M deal
Nanjing, China-based Simcere Pharmaceutical Co. Ltd. became the second Chinese player to seek assets from G1 Therapeutics Inc., of Research Park Triangle, N.C., this year. On Tuesday, it licensed trilaciclib, an intravenous CDK4/6 inhibitor, from G1 Therapeutics in a $170 million deal for Greater China rights.

Simcere licenses CDK4/6 inhibitor from G1 Therapeutics in $170M deal
Nanjing, China-based Simcere Pharmaceutical Co. Ltd. became the second Chinese player to seek assets from G1 Therapeutics Inc., of Research Park Triangle, N.C., this year. On Tuesday, it licensed trilaciclib, an intravenous CDK4/6 inhibitor, from G1 Therapeutics in a $170 million deal for Greater China rights.
Celltrion doubles pace for COVID-19 antibody treatment CT-P59
HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials.
Indian deadline for COVID-19 vaccine raises doubts
NEW DELHI – If India’s government has its way, the country could launch a vaccine for COVID-19 in mid-August, an extremely short deadline that has caused controversy and pushed companies to speed up their development and the trials of prospective vaccines.
Henlius’ Herceptin biosimilar wins EU approval, marks Chinese players entry to Europe
Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
News in brief
BioWorld Asia briefs for Aug. 4.
Hong Kong PolyU and Macau UST develop recombinant RBD vaccine against COVID-19
Universities in China’s Greater Bay Area have developed a recombinant receptor-binding domain (RBD) protein vaccine candidate that has shown promise against COVID-19, researchers said Monday.
Terns out-licenses BCR-ABL inhibitor for CML to Hansoh to accelerate entry to clinic
Terns Pharmaceuticals Inc., a NASH specialist based in San Francisco and Shanghai, has out-licensed the Greater China rights of its BCR-ABL inhibitor, TRN-000632, for treating chronic myeloid leukemia (CML) to Chinese pharma giant Hansoh Pharmaceutical Group Co. Ltd. to move the preclinical oncology asset to the clinic faster.
Taiwan’s Senhwa advancing CK2 candidate against moderate COVID-19
Senhwa Biosciences Inc., of Taipei, Taiwan, said casein kinase 2 (CK2) is the right target to aim at when developing a COVID-19 therapeutic treatment. The company’s silmitasertib is the only clinical-stage inhibitor of CK2, a kinase recently identified by researchers as being hijacked by SARS-CoV-2.
Iacta Pharmaceuticals and Zhaoke Ophthalmology agree to co-develop novel eye treatments
HONG KONG – California-based Iacta Pharmaceuticals Inc. and Hong Kong-based Zhaoke Ophthalmology Pharmaceutical Ltd. have inked a definitive license agreement for two of Iacta’s products.

Analysis and data insight

Snowballing research preps avalanche to bury COVID-19
Vaccine
Research focused on finding viable solutions to counter the COVID-19 pandemic continues at an explosive pace with a total of 588 potential therapeutics and vaccines at the forefront of scientific efforts launched by industry, academia and government.
BIO Digital: Industry looks for collaboration, recognition in COVID-19 efforts
Conferences
The biotech industry's rapid response to COVID-19, a pivot of global scope, is driving a broad array of approaches to tackling the infection. On Monday, the first day of BIO's virtual convention, the trade group gathered some of the effort's leading voices to take stock of how those efforts are...
Biopharma builds arsenal, launches showdown to squash COVID-19
Coronavirus
Swept up into a coronavirus whirlwind, the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that nobody could have imagined only months ago.
Amid pandemic, companies scramble to salvage trials, move virtual
FDA
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials.

Financings

China’s Sunshine Guojian prices $240M IPO on STAR, shares jump 92% on first day
Cancer
HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of 92%.

Australia

Australia garners first CARB-X award to fight antibiotic resistance with new class of antibiotics
Infection
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).

Australia’s Neuren raises AU$20M to advance NNZ-2591 to the clinic in three orphan indications
Neurology/Psychiatric
PERTH, Australia – Melbourne-based Neuren Pharmaceuticals Ltd. will be able to progress NNZ-2591 to the clinic for three orphan indications after raising AU$20 million (US$13.75 million) in a placement to institutional and sophisticated investors in Australia, New Zealand, Hong Kong and the U.K.
Australia’s Cynata ahead of the pack as it progresses iPSCs to phase III osteoarthritis trial
Inflammatory
PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is gearing up to take its Cymerus mesenchymal stem cell (MSC) product candidate, CYP-004, into a phase III trial in osteoarthritis.

China

Hacking indictment details decade of thefts, ramps up U.S.-China tensions
Drugs
The alleged activities of two Chinese hackers outlined in a federal indictment unsealed Tuesday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said, as U.S.-China relations further soured with the news of the charges.
China's Sinovac phase III trials in Brazil could take as little as three months
Vaccine
CAJICA, Colombia, and BEIJING – Last week Sinovac Biotech Ltd., of Beijing, announced the approval by Anvisa, the Brazilian health care surveillance agency, to start phase III trials to test the efficacy and safety of its inactivated COVID-19 vaccine being developed by Sinovac Life Sciences, a subsidiary of the Chinese company, in the Latin American country.
Roche, Boehringer Ingelheim push further into China
Collaboration
HONG KONG- Boehringer Ingelheim International GmbH and Roche Holding AG have announced new initiatives to seek R&D collaborations in China, increasing both their footprint in China and China’s global biopharma presence. Boehringer Ingelheim announced earlier this month the launch of an External Innovation Hub in Shanghai. Meanwhile, Roche China also launched a collaboration initiative this week to develop therapies for gastrointestinal cancer.
Immunotech CEO: IPO shines light on China’s innovation in cell therapy
Immunotherapy
BEIJING – Beijing-based Immunotech Biopharm Ltd. made a strong debut as the first pre-revenue cellular immunotherapy firm to trade on the Hong Kong Stock Exchange (HKEX), raising $142 million via its IPO. Trading under the ticker 6978, the company’s share price closed at HK$15.48 (US$2) on July 10, up 40.7% from its offer price at HK$11.
China’s Kintor to provide AR antagonist for COVID-19 trial in Brazil
Latin America
BEIJING – Androgen receptor (AR) antagonist developer Kintor Pharmaceutical Ltd., of Suzhou, China, is going to provide its proxalutamide (GT-0918) to an ongoing clinical trial in male patients, led by U.S. firm Applied Biology Inc., in Brazil for COVID-19, after preliminary clinical research suggested a potential link between androgenetic alopecia and COVID-19 pathogenesis.

Regulatory

Regulatory front for Aug. 4, 2020
The latest global regulatory news, changes and updates affecting biopharma, including: Medicines and Healthcare Products Agency, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.

Newco news

G2GBIO seeks further funds after $9.53M series B financing
Diabetes
HONG KONG – Daejeon, South Korea-based biotechnology company G2GBIO Inc. has raised ₩11.4 billion (US$9.53 million) from a series B financing round, with the funds to be used on clinical trials for a sustained-release Alzheimer’s treatment as well as nonclinical trials for diabetes and...

After EU withdrawal, catumaxomab ready for phase III trials again under China’s Lintonpharm
Cancer
The first bispecific antibody to win regulatory approval, Removab (catumaxomab) was voluntarily withdrawn due to commercial reasons. Now Chinese biotech Lintonpharm Co. Ltd., of Guangzhou, said it plans to move catumaxomab to a global phase III trial following an IND approval from China’s NMPA,...
Australia’s Brandon Capital leads AU$29 M series A investment in Glyscend’s diabetes polymer compound
Diabetes
PERTH, Australia – With a series A investment in hand, Glyscend Therapeutics Inc. will take its polymer therapeutic that mimics the effect of gastric bypass surgery to Australia next year to begin clinical trials.

Science

COVID-19: Trying for herd immunity without vaccine ‘unethical’ and ‘unachievable’
Europe
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response.
CAR T cells target senescence marker, ameliorate cancer, fibrosis
Gastrointestinal
By targeting chimeric antigen receptors (CARs) to a senescence marker, researchers at Memorial Sloan-Kettering Cancer Center have developed a CAR T cell that had beneficial effects in mouse models of both liver fibrosis and lung cancer.
Centrifugation can be child’s play with fidget spinners
Genitourinary/Sexual Function
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually.
Germline ApoE variants affect melanoma trajectory
Cancer
Variants in the APOE gene are the strongest genetic risk factor for developing Alzheimer’s disease (AD). Now, researchers at Rockefeller University have demonstrated that APOE variants also affected the risk of progression and metastasis as well as the response to immunotherapy, in melanoma.
Phosphatases are yin to kinases’ yang
Conferences
The activity of many proteins is controlled through phosphorylation by kinases and dephosphorylation by phosphatases.
In vitro study gives ‘blueprint’, drug leads for SARS-CoV-2
A multi-institutional group led by the University of California at San Francisco’s Quantitative Biosciences Institute (QBI) has identified more than 200 host proteins that interacted with SARS-CoV-2 viral proteins during infection, creating “a blueprint of how SARS-CoV-2 hijacks human cells.”

BioWorld Perspectives

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
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...
Shoes, ‘Stones’ and surfing: BioWorld’s 12th annual Summer Reading List
BioWorld
Summer arrives with a bang for biopharma in the dueling agendas of the American Society of Clinical Oncology (ASCO) annual meeting, the BIO International...

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