Mesoblast scores first US nod for mesenchymal stromal cell therapy
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.

Mesoblast scores first US nod for mesenchymal stromal cell therapy
Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), for steroid-refractory acute graft-vs.-host disease (SR-aGvHD) in children 2 months and older, including adolescents.
Any Betta? FDA adds Ensacove to ALK lung cancer weaponry
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
Merck strikes a $2B GLP-1 deal with Hansoh
Merck & Co. Inc. has turned to Asia for a second time to get into the GLP-1 market, this time to Shanghai-based Hansoh Pharmaceutical Group Co. Ltd. for its investigational preclinical oral small-molecule GLP-1 receptor agonist. Hansoh is getting $112 million up front and could bring in another $1.9 billion in milestone payments. Merck said the addition to its GLP-1 arsenal is “to provide additional cardiometabolic benefits beyond weight reduction.”
Sangamo and Astellas link up in a $1.32B AAV deal
Sangamo Therapeutics Inc.’s second large, worldwide licensing deal for its capsid technology in the past five months is with Astellas Pharma Inc. The California-based company is getting $20 million up front and the chance to bring in up to $1.3 billion in fees and milestone payments in an agreement spanning five potential disease targets for gene therapies to treat neurological diseases.
China gives thumbs up to Innovent’s taletrectinib for lung cancer
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
In 2024, pandemic breakthroughs were for better and for worse
First, the good news about pandemics – and in 2024, there was big “good news.” Science Magazine named lenacapavir (Gilead Sciences Inc.) as the Breakthrough of the Year. In two separate trials, lenacapavir prevented HIV transmission with 100% efficacy in cisgender African women and 99.9% efficacy in men and gender-diverse persons when administered twice a year.
Sanofi expands SK Bio deal, starts phase III of GBP-410
SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs). The first deal resulted in GBP-410 (SP-0202), its pediatric 21-valent PCV candidate that moved into phase III study last week.
AI cancer firm Oncocross debuts with $60M IPO on Kosdaq
AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).
Cancer, GI-focused Onconic shares take off after ₩20B IPO
Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting.
Flagship’s Generate Bio scores investment from Samsung fund
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.
Year in review 2024: Top deals
The top 10 deals announced in 2024.
Year in review 2024: Top M&As
The top 10 M&As announced in 2024.
News in brief
BioWorld Asia briefs for December 24, 2024.

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Analysis and data insight

November’s 10 billion-dollar deals cap 2024 as record year
Deals and M&A
Biopharma deal activity in November reached $29.18 billion, up from $22.29 billion in October. Year-to-date deal values have increased 3.6%, from $194.13 billion in the first 11 months of 2023 to $201.19 billion through November this year, overtaking 2023 to be the highest year on record through...
Biopharma financing climbs 46% YTD; $97.42B raised through November
Financings
Biopharma companies have raised $97.42 billion through November 2024, up 46% from $66.79 billion during the same period in 2023 and also more than $56.56 billion in 2022.
Hanmi Pharm invests ₩140B to grow China production, R&D base
Cancer
Beijing Hanmi Pharm. Co. Ltd. broke ground on a ₩140 billion (US$98.65 million) large-scale project to build a near-500,000-square-foot China base near Beijing Capital International Airport in efforts to increase the company’s local production, R&D and office capabilities.
HIF 2024: Immune system could be key to neurodegenerative disease
Conferences
Our immune cells are not just “defenders” against deadly viruses and pathogens but also a great balancer for tissue homeostasis. For neurological disorders, understanding the neuro-immune axis could be key to treating previously untreatable conditions such as autism spectrum disorder, according to...

Financings

Paradigm's AU$16M moves Zilosul to pivotal osteoarthritis trials
Clinical
Paradigm Biopharmaceuticals Ltd. raised AU$16 million (US$10.31 million) in a placement that will allow the company to start a global phase III trial with its lead product, Zilosul (injectable pentosan polysulfate/iPPS), to treat osteoarthritis.

Australia

SK Bioscience to start mRNA vax trial for Japanese encephalitis
Clinical
SK Bioscience Co. Ltd. gained approval from the Human Research Ethics Committee in Australia to start phase I/II trials of GBP-560, its mRNA-based vaccine candidate for mosquito-borne Japanese encephalitis virus, with funding from Coalition for Epidemic Preparedness Innovations.

Recce moves to pivotal trials in Indonesia for diabetic foot ulcers
Clinical
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James...
Bionomics progresses BNC-210 to phase III in PTSD
Regulatory
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.

China

Caliway’s CBL-514 meets endpoints in reducing abdominal fat
Clinical
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye
Regulatory
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Cstone’s ROR1 ADC chases Merck’s, plus China biotech data: ASH 24
Clinical
Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase...
NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases
Regulatory
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Keymed, Platina sign $626M deal for bispecific antibody CM-336
Deals and M&A
Keymed Biosciences Co. Ltd. is out-licensing global rights, excluding China, for its bispecific antibody, CM-336, to Platina Medicines Ltd. in a deal worth up to $626 million plus sales royalties.

Regulatory

Two Stelara biosimilars among 15 US FDA approvals in October
Analysis and data insight
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.

Newco news

AI Medi Scan develops at-home melanoma detection app
Cancer
Australia is the skin cancer capital of the world, but with a shortage of dermatologists, patients often wait too long to get skin checks that could end up costing them their lives.

Dermr could displace skin biopsies with microneedle patch
Cancer
Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with...
Genor wins $440M+ cancer drug deal with Third Rock/Two River firm
Deals and M&A
China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC.

Science

A single mutation in H5N1 is all that’s needed for easier transmissibility
Infection
Although it does not generally infect humans, a single mutation of the H5N1 virus in the highly pathogenic avian and bovine clade 2.3.4.4b could overcome this barrier and possibly trigger a pandemic.
More than 100M cells included in the human cell atlas
Artificial intelligence
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will...
ESGCT 2024: Steps forward in gene and cell therapies for brain tumors
Conferences
Scientists from different laboratories around the world have presented the latest advances in research into malignant brain tumors at the 31st Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), which is being held Oct. 22 to...
Synthesis Bioventures founder wins Aussie innovation award
Cancer
When Andrew Wilks invented the JAK inhibitor momelotinib in the late 1980s for myelofibrosis, he never would have imagined it would take more than 20 years to develop and eventually be acquired for $1.9 billion. Today he’s on a mission to ensure...
Study paves way for therapy, easier diagnosis in endometriosis
Endocrine/metabolic
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama...
Alternative splicing study reveals genetic variants across Indonesian archipelago
Omics
A new study helps explain the role of genetic variation in shaping gene regulation in the Indonesian archipelago, one of the most diverse regions in the world. “This study is the only study of splicing from Southeast Asian populations. There is...

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