CS Pharma gains Chinese rights to Daewoong’s antifibrotic agent, bersiporocin, in $336M deal
Daewoong Pharmaceutical Ltd. has out-licensed greater China rights for its idiopathic pulmonary fibrosis (IPF) candidate, bersiporocin (DWN-2088), to CS Pharmaceuticals Ltd. in a deal worth up to $336 million. Bersiporocin is a prolyl-tRNA synthetase inhibitor being developed by Daewoong for IPF and potentially other fibrotic indications.

CS Pharma gains Chinese rights to Daewoong’s antifibrotic agent, bersiporocin, in $336M deal
Daewoong Pharmaceutical Ltd. has out-licensed greater China rights for its idiopathic pulmonary fibrosis (IPF) candidate, bersiporocin (DWN-2088), to CS Pharmaceuticals Ltd. in a deal worth up to $336 million. Bersiporocin is a prolyl-tRNA synthetase inhibitor being developed by Daewoong for IPF and potentially other fibrotic indications.
China approves two oral drugs to treat COVID-19
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
Hutchmed looks beyond China as Takeda gains colorectal cancer asset in $1.13B deal
Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau.
China’s Alpha Biopharma seeks new drug status for EGFR-TKI product
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
Australia begins first independent review of its health technology assessment process
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
China adds 111 new drugs to NRDL, focus on innovation
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
China grapples with regulating online drug sales
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
News in brief
BioWorld Asia briefs for Jan. 31.
ABVC Biopharma on the path to validating traditional medicine for the modern world
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models.
Mabwell out-licenses preclinical iron metabolism MAb to Disc Medicine in $412M deal
Just in time for the Chinese New Year, Mabwell Bioscience Co. Ltd. announced that its U.S. subsidiary, Mabwell Therapeutics Ltd., closed a licensing deal with Disc Medicine Inc. worth up to $412 million.
FDA lifts clinical hold on Astellas Fortis AAV gene therapy trial in Pompe disease
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
FDA grants breakthrough therapy designation to Abbisko’s CSF-1R inhibitor, pimicotinib
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
India drug regulations under the scanner again after fresh WHO alert on contaminated cough syrup
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
Holiday notice
BioWorld Asia was not published Jan. 25, 2023, due to the Lunar New Year holiday.

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Analysis and data insight

Shy of the prior year, deals reach $206B in 2022; M&As fall behind by 36%
Deals and M&A
While it made a sturdy effort as biopharma companies opted for licensing deals over M&As in 2022, the year did not surpass 2021 in deal values, falling about 3.5% short. Lackluster M&A values dropped to their lowest levels in five years and were down by 35.6% compared with 2021.
Emerging from the worst pandemic in a century
In the fourth year of the COVID-19 pandemic, the World Health Organization is monitoring two omicron subvariants, BA.5.2 and BF.7, causing a surge of COVID-19 cases in China. It also is keeping abreast of rising XBB.1.5 cases and declining BQ.1 cases in Europe and the U.S., where hospitalizations...
Top Trends of 2022: Asia Pacific shakes off pandemic isolation, but focus remains on sovereign supply chains, regional deals
Deals and M&A
Investment in the fourth quarter of 2022 was dismal in Asia Pacific, as the global venture community focused on preserving capital. And the region faced other challenges throughout the year, as leaders in Australia and across Asia became acutely aware of the vulnerabilities in their supply chains....
Bebtelovimab out, Kineret in, as US and globe fight to end the pandemic
Coronavirus
The world is emerging from the COVID-19 pandemic, as both cases and deaths have remained consistently low in recent months, despite continuous mutation of the SARS-CoV-2 virus. Nevertheless, there is a shuffling of candidates in the arsenal as new variants bump once-effective therapies and the next...

Financings

CR Biopharm nets $89M series B for clinical trials, partnerships
Series B
China Resources Biopharmaceutical Co. Ltd. (CR Biopharm) raised ¥600 million (US$89 million) in a series B round led by China Structural Reform Fund Co. Ltd.

Australia

After fecal microbiota approval, Biomebank to develop synthetic treatments for gut microbiota
Regulatory
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a...

Australia delivers new National Medicines Policy aiming to deliver greater access to medicines
Regulatory
The Australian government delivered an early Christmas present to the biopharma industry in the form of a new National Medicines Policy giving voice to major industry goals – among them a clear vision to “achieve the world’s best health, social and economic outcomes for all Australians through a...
Vaxxas raises $23M to advance needle-free COVID-19 vaccines
Medical devices and technologies
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the...

China

China drops Paxlovid coverage despite rising COVID cases
Regulatory
China's National Healthcare Security Administration will not be adding Pfizer Inc.'s COVID-19 treatment Paxlovid to its list of medicines covered by basic medical insurance schemes in the country, due to its high prices.
China’s clinical trial landscape is evolving quickly toward innovation
Clinical
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
China grants emergency use authorization for Merck’s COVID-19 drug
Regulatory
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
Recbio’s COVID-19 vaccine shows strong efficacy in phase II Philippines trial
Clinical
Jiangsu Recbio Technology Co. Ltd. released phase II data showing its recombinant two-component COVID-19 vaccine Recov appeared more effective than Comirnaty (tozinameran), the mRNA vaccine developed by Biontech SE and Pfizer Inc., as a booster for users of inactivated vaccines.
Sciclone gets green light for naxitamab for patients with neuroblastoma in China
Regulatory
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1...

Regulatory

Biogen, Eisai win FDA clearance for AD therapy Leqembi
Neonatal/Pediatrics
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.

Newco news

E-nitiate Biopharma raises $14.4M to develop drugs for dermatosis
Dermatologic
E-nitiate Biopharmaceuticals Co. Ltd. has raised ¥100 million (US$14.4 million) in a series A round to speed up the clinical trials of its lead assets, QY-201 and QY-101, and expand the pipeline. “Our strategy is to focus on the ‘blue ocean’ of the dermatosis market,” said Shi Jun, chief medical...

Avelos raises $8M series A funding to develop biomarker-driven oncology pipeline
Cancer
Startup Avelos Therapeutics Inc. raised $8 million in series A funding that will launch the company’s biomarker-driven cancer therapy pipeline using its synthetic lethality platform. Participating in the series A funding were SV Investment, UTC Investment, Quad Investment Management, Timepolio...
Alterity begins phase II trial with lead candidate ATH-434 in multiple system atrophy
Clinical
Alterity Therapeutics Ltd. has begun phase II trials with its lead candidate, ATH-434, in multiple system atrophy, a rare and highly debilitating Parkinsonian disorder.

Science

Amyloid plaques recast as cause of neural network dysfunction
Neurology/Psychiatric
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about...
ENA 2022: Mutant specific or target selective, that is the question for drug development
Conferences
Diwali, the Festival of Light, marks different events depending on where it is celebrated. In some areas of India, it marks the return of Lord Rama to his birthplace of Ayodhya after defeating the demon Ravana.
Gut microbiota degrade intestinal nicotine, alleviate smoking-related liver disease
Gastrointestinal
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease...
CRISPR activation mouse model can turn on previously silenced genes
Drug design, drug delivery and technologies
Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, Australia, have developed a new genome editing technique than can activate any gene, including those that have been silenced, allowing new drug targets and...
Laskers go for integrins, prenatal testing, COVID-19 dashboard
Diagnostics
The 2022 Albert Lasker Basic Medical Research Award has been awarded to Richard Hynes, of the Massachusetts Institute of Technology, Erkki Ruoslahti, of the Sanford Burnham Prebys Medical Discovery Institute, and Timothy Springer, of Harvard...
From ancient DNA, a Nobel Prize, and perhaps modern drug targets
Genetic/Congenital
The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo today "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for...

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