China launches price war to reshuffle pharma industry; Bayer cuts prices by 90% to secure market
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price war has forced foreign players to revalue the Chinese market and prompted Chinese players to come up with survival strategies under a policy that aims to consolidate the industry.

Chi-Med’s surufatinib phase III trial halted early after meeting primary endpoint in advanced pancreatic NET
China’s I-Mab goes public in targeted range for $103.7M; after-market deep Zai?
Industry: Trade agreement important first step toward fairer Chinese market
Noxopharm spin-off Nyrada lists on ASX raising AU$8.5 million in oversubscribed IPO
Bionetix secures $9.33M in series B funding for AML/MDS and glaucoma treatment

China launches price war to reshuffle pharma industry; Bayer cuts prices by 90% to secure market
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price war has forced foreign players to revalue the Chinese market and prompted Chinese players to come up with survival strategies under a policy that aims to consolidate the industry.
Chi-Med’s surufatinib phase III trial halted early after meeting primary endpoint in advanced pancreatic NET
BEIJING – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) called an early stop to its phase III pivotal study of surufatinib in advanced pancreatic neuroendocrine tumors (NET) in China after it met the predefined primary endpoint of progression-free survival.
China’s I-Mab goes public in targeted range for $103.7M; after-market deep Zai?
Shanghai-based I-Mab Biopharma Co. Ltd. became the first IPO out of the gate this year, pricing its IPO of about 7.4 million American depositary shares (ADSs) – each 10 representing 23 ordinary shares of the company, par value $0.0001 per share – at $14 each, within the planned range of $12 at the low end and $15 at the high. But the stock’s performance might not have been all investors hoped, as shares (NASDAQ:IMAB) closed at $12.50 Jan. 17.
Industry: Trade agreement important first step toward fairer Chinese market
Time will tell whether what the Trump administration is calling a “historic” and “landmark” trade agreement with China will better enable drug and device companies to more fairly compete in the Chinese market without having to sacrifice their intellectual property (IP) and technology.
Noxopharm spin-off Nyrada lists on ASX raising AU$8.5 million in oversubscribed IPO
PERTH, Australia – Sydney-based Noxopharm Ltd. announced that its spin-off, Nyrada Inc., began trading on Australia’s Securities Exchange (ASX:NYR) on Jan. 16, following an oversubscribed IPO that raised AU$8.5 million (US$5.8 million).
Bionetix secures $9.33M in series B funding for AML/MDS and glaucoma treatment
HONG KONG – Bionetix Inc., of Suwon, South Korea, has secured ₩10.8 billion (US$9.33 million) in series B funding. The biotech, founded in February 2017, has attracted a total of KRW14.7 billion to date. The company will use the funds to advance NTX-301, a therapy for myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with epigenetic dysregulation, and NTX-101, a glaucoma treatment.
Oncologie boosts pipeline with phase II-ready bispecific candidate in Mereo deal
BEIJING – In a deal that adds another clinical-stage program to its pipeline, U.S.-China biotech Oncologie Inc. has picked up global rights to phase II-ready anti-DLL4/VEGF bispecific antibody navicixizumab from London-based Mereo Biopharma Group plc.
Miracogen expands ADC deal with Synaffix
HONG KONG – In less than a year, China-based Shanghai Miracogen Inc. has extended its partnership with Oss, the Netherlands based Synaffix BV for a second antibody-drug conjugate (ADCs) candidate. The new deal is similar to one signed last year in that it gives Miracogen nonexclusive rights to Synaffix’s Glycoconnect and Hydraspace ADC technologies for use in a second clinical candidate.
China promotes real-world evidence in R&D and approval with new guidelines
BEIJING – China has released guidelines to promote the use of real-world evidence (RWE) in drug development and reviews.
Aum Biosciences partners with Cyclica for cancer therapies development
HONG KONG - Singapore-based biotech Aum Biosciences Pte. Ltd., and Toronto, Canada-based biotech Cyclica Inc. have agreed to work together to apply Cyclica’s drug discovery platform in Aum’s R&D programs for the discovery of potential new cancer therapies. Aum will deploy its drug R&D skills including a biomarker-driven approach while Cyclica will contribute its AI-augmented platforms, Ligand Design and Ligand Express.

Analysis and data insight

China's financing activity slows as partnering grows, Chinabio say
Conferences
SAN FRANCISCO – Pacing the stage at this year's China Showcase Saturday, Chinabio CEO Greg Scott sounded a touch disappointed. Last year lacked the kind of record-breaking stats he likes to punctuate with iconic explosions, a common image in his widely valued China health care talks. "Simply...
Dec. 30, 2019-Jan.3, 2020: BioWorld hails 2019 as a pretty good year for biopharma
As we entered a new decade, BioWorld writers took the opportunity to review the highs and lows of the past 12 months and they concluded that 2019 was a great year for the sector – save for a few bumps in the road.
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).

Financings

Adagene raises $69M series D to advance lead immuno-oncology programs
Cancer
Adagene Inc., an immuno-oncology company with operations in both the U.S. and China, has raised a $69 million series D financing to support its development of two monoclonal antibodies (MAbs) and extension of its technology-driven in-house antibody design platform. Its two lead candidates are a phase I MAb targeting CD137 and a preclinical MAb targeting CTLA4.

Australia

As bushfires continue to burn, Australia’s regulators don’t anticipate delays
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.

Australia implements opioid reforms to deal with 150 hospitalizations per day
Regulatory
PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.
Australia unveils new companion diagnostics regulatory framework
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.

China

Innovent scores first IND for TIGIT antibody and explores PD-1/RNAi combination
Clinical
China-based Innovent Biologics Inc. will need to get on two new tasks this year: Preparing for the first clinical trial for an anti-TIGIT antibody in China and investigating the combination therapy of its Tyvyt (sintilimab) and Sirnaomics Inc.’s STP-705.
Chinese scientist faces three years in jail for creating world’s first gene-edited babies
Gene therapy
BEIJING – Chinese scientist He Jiankui has been sentenced to three years in prison and fined ¥3 million (US$429,421) for illegally carrying out the human embryo gene editing that led to the birth of twin girls and another baby with heritable changes to their genomes.
Foreign pharma’s strategy for China: Lower price for a bigger pie
BEIJING – China is aggressively pushing its goal to make drugs more affordable, and foreign pharma giants are adjusting their pricing strategy for a market that comprises nearly 20% of the world’s population and is expected to continue growing. To achieve its goals, China is using its huge population, which stands at 1.43 billion, as a bargaining chip to negotiate prices with pharmaceutical companies.
HTA and drug/device pricing in Asia in 2020
Asia-Pacific
MALAYSIA – Asian countries, like India, have been struggling to find a middle ground to the effective pricing of drugs and medical devices over the past year and several are looking at health technology assessment (HTA) programs as a solution for this issue.
Tracon buys rights to subcutaneous PD-L1 antibody from China’s 3D Medicines and Alphamab
Deals and M&A
BEIJING – U.S. biotech Tracon Pharmaceuticals Inc., of San Diego, has in-licensed from Chinese drugmakers 3D Medicines (Beijing) Co. Ltd. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. the rights to develop envafolimab, a subcutaneous PD-L1 antibody, to treat soft tissue sarcoma in North America.

Regulatory

Regulatory front for Jan. 21, 2020
The latest global regulatory news, changes and updates affecting biopharma.

Newco news

Genesen secures $1.9M for peptide-based autoimmune disease treatment
Immune
HONG KONG – South Korean biopharma Genesen Inc. has secured ₩2.2 billion (US$1.9 million) in seed funding to advance its peptide-based drug candidates for the treatment of autoimmune and inflammatory diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis and psoriasis.

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...
With another $26M, Japan’s Heartseed aims to advance iPSC-derived regenerative medicine for heart failure
Cardiovascular
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.

Science

Glutamine transporter variant identified as new cancer target
Cancer
A mitochondrial glutamine transporter variant is a key regulator of glutamine metabolism and metabolic reprogramming in cancer cells, and targeting such transporters could be a new strategy for controlling tumor growth.
Cobra genome may yield new antivenoms, venom-based drugs
Toxicity/Intoxication
A reference genome from the Indian cobra compiled in an international collaborative study should lead to the development of new safer and more effective antivenoms, while the elucidated genome and predicted associated proteome may be a powerful platform for studies of venomous snakes.
Scientists report insights into the mechanics, literally, of IPF
Respiratory
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis.
New PCa treatment strategy may overcome resistance
Cancer
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.
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.

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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