Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.

Takeda bolsters oncology pipeline via $1.3B deal for Keros’ elritercept
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Dewpoint and Mitsubishi ink $480M ALS research collaboration
Dewpoint Therapeutics Inc. and Mitsubishi Tanabe Pharma Corp. have entered a research collaboration worth up to $480 million to advance Dewpoint’s novel TDP-43 small-molecule condensate modulator for amyotrophic lateral sclerosis. Under terms of the deal, Boston-based Dewpoint will receive an undisclosed up-front payment and is eligible to receive R&D-based milestone payments up to $480 million. Upon reaching those milestones, Osaka, Japan-based MTPC will have an exclusive option to license the program and assume responsibility for global clinical development and commercialization. Dewpoint will also receive tiered royalties on net sales.
NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye
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
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 I study for lymphomas.
Hanmi Pharm invests ₩140B to grow China production, R&D base
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.
Bionomics progresses BNC-210 to phase III in PTSD
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 were presented at the American College of Neuropsychopharmacology meeting in Arizona on Dec. 9, which showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
A single mutation in H5N1 is all that’s needed for easier transmissibility
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.
Paradigm's AU$16M moves Zilosul to pivotal osteoarthritis trials
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.
Boryung invests $10M in Intuitive Machines for outer space R&D
Following its $60 million investment in Axiom Space Inc. last year, Boryung Co. Ltd. made a $10 million private placement in Intuitive Machines Inc. to grow its pharmaceutical R&D reach in outer space.
Biopharma financing climbs 46% YTD; $97.42B raised through November
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.
News in brief
BioWorld Asia briefs for December 3, 2024.

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Analysis and data insight

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...
Celltrion to expand CRDMO business, hit ₩10T sales in 2027
Clinical
South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
Two Stelara biosimilars among 15 US FDA approvals in October
Regulatory
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.
Kura, Kyowa Kirin to co-develop ziftomenib in $1.49B deal
Deals and M&A
Kura Oncology Inc. and Kyowa Kirin Co. Ltd. have joined hands in a global strategic collaboration worth $1.49 billion to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor for treating patients with acute myeloid leukemia (AML) and other hematologic malignancies.

Financings

Jiuyuan Gene raises HKD$485M in Hong Kong IPO
Endocrine/metabolic
Hangzhou Jiuyuan Gene Engineering Co. Ltd. raised HKD$485.4 million (US$62.38 million) in a November 28 IPO on the main board of the Hong Kong Stock Exchange (HKEX:2566).

Australia

Arovella heads toward clinic with CAR-19-iNKT cells
Clinical
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.

Alloplex’s Suplexa reawakens immune cells to fight cancer
Newco news
When it comes to cell therapy, Alloplex Biotherapeutics Inc. CEO Frank Borriello said he believes that autologous, personalized therapy is the only thing that makes sense. “The allure of an off-the-shelf therapy has been such a magnet. It sucked in a lot of companies into that dream, and I'm sorry...
Australia reimburses Vazkepa a decade after US approval
Regulatory
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.

China

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.
China’s NMPA accepts Ascentage NDA for Bcl-2 inhibitor lisaftoclax
Regulatory
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
FDA lifts clinical hold on Carsgen’s CAR Ts following warnings
Regulatory
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
Abbisko’s pimicotinib meets endpoints in phase III
Clinical
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
Next Generation Gene pioneers gene therapy approach with China data
Clinical
Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with...

Regulatory

Celltrion wins Korea approvals of Prolia, Xgeva biosimilars
Cancer
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs,...

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

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...
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...
Chemistry Nobel awarded for 3D protein design, prediction work
Artificial intelligence
David Baker, Demis Hassabis and John Jumper share the 2024 Nobel Prize in Chemistry for their contributions to the science of protein structure. David Baker was awarded half the prize “for computational protein design,” according to the Royal...
Two win Nobel for microRNA work
Biomarkers
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its discoverers –...

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