Australia’s R&D tax incentive threatened yet again
PERTH, Australia – Despite a Senate inquiry recommendation to hold off on introducing cuts to Australia’s Research and Development Tax Incentive (RDTI), a bill that recommends cuts was introduced in Parliament, sending shudders through the biotech industry. “Ausbiotech is deeply concerned that the RDTI Bill has been reintroduced, despite the Senate Committee’s recommendations to defer consideration of the bill until further examination and analysis of the impact is undertaken,” said Ausbiotech CEO Lorraine Chiroiu.

Australia’s R&D tax incentive threatened yet again
PERTH, Australia – Despite a Senate inquiry recommendation to hold off on introducing cuts to Australia’s Research and Development Tax Incentive (RDTI), a bill that recommends cuts was introduced in Parliament, sending shudders through the biotech industry. “Ausbiotech is deeply concerned that the RDTI Bill has been reintroduced, despite the Senate Committee’s recommendations to defer consideration of the bill until further examination and analysis of the impact is undertaken,” said Ausbiotech CEO Lorraine Chiroiu.
Luye Pharma bids to acquires Boan in $205M deal to compete in biologics
BEIJING – Luye Pharma Group Ltd., of Yantai, Shandong Province of China, has proposed to acquire Shandong Boan Biological Technology Co. Ltd. for up to $205.8 million to expand and diversify its pipeline portfolio into biologics. The payment is to be in three parts: an initial amount of $102.9 million, followed by payments linked to China marketing approval for two of Boan’s candidates of $51.45 million each.
Emphasizing synergy and efficiency, EOC Pharma raises $71M series C to fight breast, gastric cancers
BEIJING – EOC Pharmaceutical Group, of Shanghai, completed a series C financing round, bagging $71 million to advance its lead programs EOC-103 and EOC-315 for breast and gastric cancers. The round was led by Hangzhou Tigermed Consulting Co. Ltd. and its affiliated funds, TF Capital and Yingke PE. Hanne Capital and Everest Venture Capital also participated in the round. In 2017, EOC raised $32 million in a series B round. All funding participants are China-based.
New PCa treatment strategy may overcome resistance
Targeting prostate cancer (PCa) neuroendocrine (NE) cells via inhibition of the C-X-C motif chemokine receptor 2 (CXCR2) is an androgen receptor (AR)-independent therapeutic strategy that can improve the efficacy of treatment for PCa, a leading cause of male cancer mortality.
With another $26M, Japan’s Heartseed aims to advance iPSC-derived regenerative medicine for heart failure
BEIJING – Tokyo-based biotech firm Heartseed Inc., which focuses on regenerative medicine, has closed a series B financing round to pocket $26 million that will go to its lead drug candidate, HS-001, for treating heart failure.
Rapt licenses FLX-475 to Hanmi in deal worth up to $118M
HONG KONG – Rapt Therapeutics Inc., of San Francisco, and Seoul, South Korea-based Hanmi Pharmaceutical Co. Ltd. entered a license agreement for Rapt’s FLX-475 in Asia. FLX-475 is an oral, small-molecule CCR4 antagonist for cancer treatment.
China’s Clover completes $43M series B
BEIJING – Chengdu-based Sichuan Clover Biopharmaceuticals Inc. closed a series B financing round to inject another $43 million into its drug development and manufacturing operations, with a focus on biologic candidate SCB-313, developed with its Trimer-Tag technology platform.
South Korea’s Avixgen secures ₩10.6 billion in pre-IPO investment
HONG KONG – South Korea’s Avixgen Inc., which recently secured ₩10.6 billion (US$9 million) in pre-IPO investment and has raised total funding of ₩27 billion since its series A in 2015, plans to use funds to further develop drug platform technologies and therapeutics for virus-causing diseases such as HIV-1/AIDS.

Analysis and data insight

Indian pharma sector needs to learn from its competitors: report
Asia-Pacific
NEW DELHI, India – While India is still an attractive prospect for investment in biotechnology, the country needs to learn from the successful examples of other countries, including its Asian biotech competitors, according to a new report.
In India, government steps up efforts to develop more TB testing and treatment
Infection
HYDERABAD – India, home to a quarter of the global tuberculosis (TB) cases, plans to enhance its capacity to fight TB drug resistance and bolster susceptibility testing under a new initiative launched by the Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND).
Population-based cancer registries needed for treatment, prevention efforts
Conferences
SINGAPORE – Population-based cancer registries were a frequent focus of discussion at the ESMO Asia Congress.
Analysis by U.K. startup Medbelle highlights extent of drug pricing disparity
Drugs
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines in 50 countries worldwide.

Financings

Australia’s Opthea raises AU$50M to advance OPT-302 to phase III in wet AMD
Ocular
PERTH, Australia – On the heels of positive phase IIb data, Opthea Ltd. announced a private placement of AU$50 million (US$33.87 million) from institutional investors in Australia and the U.K. to advance lead candidate OPT-302 to phase III trials in wet AMD.

Australia

Australia’s Kazia Therapeutics reports positive interim results in phase II glioblastoma trial
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd.’s shares soared nearly 82% this week on positive interim results for lead molecule GDC-0084 in a phase II glioblastoma trial. Data from the first nine patients in the study show that GDC-0084 treatment resulted in a median progression-free...

National stem cell roadmap provides cohesive vision, funding for Australia's regenerative medicine sector
Conferences
MELBOURNE, Australia – Although Australia was one of the first movers in the regenerative medicine space, until now a cohesive plan for investing in regenerative medicine was holding the sector back.
Australia's biotechs grapple with reimbursement system for cell therapies
Conferences
Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies.

China

China updates reimbursement drug list, further encourages innovation at home
Regulatory
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
Is China ready for first-in-class? Not quite, but we must go ahead with innovation, experts say
Conferences
SHANGHAI – As Chinese biotech companies talk more about innovation, one question is whether they are ready to move into first-in-class drugs from me-too and fast follow-up drugs. To biotech executives, the China first approval for Fibrogen Inc.'s roxadustat, a first-in-class small molecule for amenorrhea, is a wake-up call.
Too many PD-1s? Facing a competitive landscape, Chinese firms seek ways to stand out
Conferences
SHANGHAI – With abundant venture capital and favorable policies, Chinese biotech companies are actively turning themselves from generic makers into innovation-driven players, but the market is getting crowded by too many companies focusing on the same area and even the same targets, a reality that is leading to a lack of differentiation in biotech innovation.
Foreign pharma can leverage China’s regulatory pragmatism, patients and lower trial costs
Conferences
SHANGHAI – Now is the time for foreign pharmaceutical companies to include China in their strategies, as the country's recent regulatory reform, vast patient pool and lower costs represent opportunities to score approvals faster, said experts at the Chinatrials12 Summit.
With the help of trial experts, Chinese biotechs set sail for global market
Clinical
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.

Regulatory

Celltrion’s Remsima SC wins marketing approval in EU
Immune
HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.

Newco news

China’s first AI microbiome firm Xbiome raises over $14M in series B
BEIJING – Shenzhen-based Xbiome Co. Ltd., said to be China’s first AI-based microbiome drug development company, closed a series B financing round to pocket ¥100 million (US$14 million).

SL Bigen secures ₩3B from Yuhan for CAR-NK therapy
HONG KONG – South Korean pharmaceutical giant Yuhan Corp. has invested ₩3 billion (US$2.6 million) in SL Bigen Co. Ltd., a Korean biotech based in Seongnam, Gyeonggi-do, that is focused on chimeric antigen receptor-directed natural killer (CAR-NK) therapy.
Australia's Cartherics creates next generation CAR T therapies
PERTH, Australia – Melbourne-based Cartherics Pty Ltd. plans on taking its pluripotent stem cell technology into the clinic next year. It is employing advanced gene editing techniques for the next generation of CAR T therapy.

Science

Australian researchers create kidney tissue from iPS cells
Stem cells
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells.
Schizophrenia biomarker can be detected in human hair
Neurology/Psychiatric
A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.
New method moves genome editing toward 'prime' time
A team at the Broad Institute of Harvard and MIT has developed a genome editing method that could, in principle, correct 90% of the roughly 75,000 currently known genomic changes that are associated with genetic diseases.
New small-molecule inhibitors block apoptosis in mice
Small molecule
Australian researchers have developed the first potent new small-molecule inhibitors capable of blocking the activation of apoptotic cell death before it causes damage to mitochondria, they reported in a study published in the Oct. 7, 2019, issue of Nature Chemical Biology.
Study shows just how far precision target ID has yet to go
Cancer
Ten targeted cancer drugs currently being tested in clinical trials involving 1,000 patients do not reach the targets at which they are aimed, according to recently published research.
Coagulation factors shown to be effective against resistant gram-negatives
Plasma coagulation factor VII (FVII), FIX and FX have been shown to be effective antibacterial proteins against drug-resistant gram-negative bacteria and may offer alternative strategies for combating the increasingly urgent global health threat posed by those resistant pathogens.

BioWorld Perspectives

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...
If no one reads it, what’s the purpose of a drug label?
BioWorld
Robert Califf said it when he was serving as FDA commissioner. Patient advocates have said it when testifying before Congress or commenting at public...

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