Travere licenses out rare kidney disease drug to Renalys in Asia
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.

Travere licenses out rare kidney disease drug to Renalys in Asia
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
Australia takes first steps toward meaningful reforms to health technology process
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
Genexine files for Korea approval of Efesa for CKD-linked anemia
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Aravax secures $22M to close series B for peanut allergy therapy
After raising $20 million in a series B round in December 2022, Aravax Pty Ltd. has raised another $22 million to close out its series B round with $42 million that expands the syndicate with new investors Novartis Venture Fund, Breakthrough Victoria, Uniseed, Unisuper, and Agati Capital. The funds will take the company’s peanut allergy immunotherapy, PVX-108, through phase II trials.
Seegene pushes ambitious DTx tech-sharing initiative with Microsoft
In a post-pandemic world, South Korean molecular diagnostics firm Seegene Inc. is looking to ignite a new paradigm in the diagnostics business. Seoul-based Seegene is rolling out a new strategy of open innovation under its newfound initiative coined the “SG Onesystem,” which pledges to not only accelerate global partnerships for novel diagnostics but also “free the world of all disease.”
News in brief
BioWorld Asia briefs for January 30, 2024.
BIO’s infectious disease report: Meager investment puts world at risk
Be it viral, nucleic acid or protein vaccines, recent efforts that led to the first regulatory approvals for not only COVID-19, but also for malaria and respiratory syncytial virus, positioned infectious diseases in the headlines for much of the last four years.
Newco news: Vision Care’s iPS retinal cells primed for global market
Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.
Sciwind moves to once-weekly dosing after oral GLP-1 delivers strong phase I obesity data
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
Clinical trial updates up 5% in 2023 despite year-end slowdown
For full year 2023, clinical trial updates saw a 5.23% increase compared to the corresponding period last year. In December, BioWorld tracked 281 phase I-III clinical trial updates, a decline from the 354 noted in November and 416 reported in October.

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Analysis and data insight

2023 gainers and losers: Positive trial outcomes and M&As propel biopharma stocks to strong finish
Biopharma stocks saw a resurgence in 2023, with the BioWorld Stock Index finishing the year with a gain of 33.59%, in contrast to the 32.75% decline in 2022. An analysis of 516 stocks from the index showed that 193 companies (37%) concluded the year on a positive note, while shares of 322 companies...
Biopharma deals and M&A remain on track to outpace 2022
Deals and M&A
Biopharma deals totaled $18.97 billion in November, marking a notable decrease from October’s historic deal value of $44.91 billion. Even still, through the first 11 months of 2023 cumulative deal value reached $194.26 billion, an 18.65% gain over the $163.73 billion recorded in the same period in...
Biopharma funding hits $5.65B in November, with 18% increase YTD
Financings
In November, the biopharma industry raised $5.65 billion in total financings. While down from $11.6 billion tracked by BioWorld in October, overall financings are tracking ahead of last year. Biopharma funding has maintained an average of $6.1 billion per month in 2023, surpassing the $5.07 billion...
Biopharma grants see 75% growth YOY, while nonprofit deals decline
Grant
Biopharma grants have sustained the upward trajectory noted in August, ending October up nearly 75% compared to the corresponding period last year. In contrast, nonprofit deal value has continued its year-over-year decline, marked by a more than 90% decrease in value.

Financings

Korean gene therapy firm Genecraft draws ₩10B in series A
Cancer
As gene therapies gain unprecedented traction into 2024, preclinical-stage South Korean biotech Genecraft Inc. said it raised ₩10 billion (US$7.48 million) in a series A financing to further R&D for its therapy against lung cancer.

Australia

FDA offers life support to Mesoblast’s Revascor via rare pediatric disease designation
Regulatory
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.

Axelia Oncology takes its TLR2/6 agonist into the clinic to harness the innate immune system
Newco news
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially...
Starpharma’s dendrimer platform meets metastatic cancer endpoints in phase II
Clinical
Starpharma Holdings Ltd.’s DEP docetaxel phase II trial met its primary endpoints, demonstrating antitumor activity in multiple advanced, metastatic cancers, including pancreatic, gastro-esophageal, non-small-cell lung cancer and cholangiocarcinoma.

China

NMPA approves China’s second homegrown SGLT2 inhibitor janagliflozin
Regulatory
Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the...
Biontech and Dualitybio progress HER2 ADC to pivotal trials in China in metastatic breast cancer
Clinical
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia
Regulatory
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
Asia CDMO giants Wuxi and Samsung to grow production, ADC capacity
Conferences
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
Innovent’s mazdutide meets endpoints in phase III obesity trial
Clinical
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA...

Regulatory

FDA issues complete response letter to Satsuma for migraine NDA over CMC issues
Neurology/psychiatric
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for...

Newco news

Perpetual aims to be peptide powerhouse
Artificial intelligence
The field of peptides is exploding, Perpetual Medicines Corp. co-founder, chairman and CEO Kerry L. Blanchard recently told BioWorld, “with a projected growth rate far surpassing large and small molecules, and gene therapies. The area is underinvested, too, so this is a good opportunity to focus on...

Perpetual aims to be peptide powerhouse
Artificial intelligence
The field of peptides is exploding, Perpetual Medicines Corp. co-founder, chairman and CEO Kerry L. Blanchard recently told BioWorld, “with a projected growth rate far surpassing large and small molecules, and gene therapies. The area is underinvested, too, so this is a good opportunity to focus on...
Longevity AI-biotech Gero raises $6M in series A round for aging research
Series A
“Aging is not only slow, but it is irreversible, and that is what most people have been suspecting,” Gero Pte Ltd.’s CEO Peter Fedichev recently told BioWorld. “[But] aging is not an inevitable part of human existence.” By setting limits to what science can do – and not do – for aging, the Palo...

Science

Proteomic signature can identify long COVID
Proteomics
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six...
MS? Blame great-great-great-great-great-great-great-great-grandma
Genetic/congenital
Current risk genes for some diseases such as multiple sclerosis (MS) may have emerged in the past as protection against infection by different pathogens. A group of researchers led by scientists from the University of Copenhagen has analyzed the...
In 2023, big projects create ‘satellite maps’ of cell biology
Artificial intelligence
If we unraveled the DNA of the 46 chromosomes of a single human cell, it would barely measure 2 meters. If we did the same with the rest of the body, if we aligned the 3 billion base pairs of its 5 trillion cells, we could travel the distance from...
1st chimeric monkey born with large embryonic stem cell contribution
Drug design, drug delivery and technologies
Investigators at the Chinese Academy of Sciences have generated a chimeric monkey by injecting an embryonic stem cell into the morula, which is an extremely early embryo consisting of 16 to 32 cells. The animal survived for only 10 days, and it is...
ESMO 2023: New approaches to old targets, including HER2 and p53
Conferences
Some cancers with a poor prognosis have had no new treatments in decades. Advances in the genetic characterization of these tumors now offer a range of possibilities for the development of new therapies that could completely change the quality of...
Nobel Prize in Chemistry 2023 goes to quantum dots, which illuminated the path to nanotechnology
Drug design, drug delivery and technologies
Quantum dots, a phenomenon in quantum physics that alters the energy of electrons and changes the properties of particles, caught the attention of the Royal Swedish Academy of Sciences (KVA) for the 2023 Nobel Prize in Chemistry.

podcast microphone, sound waves on purple background Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.

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