Shionogi, Grünenthal ink licensing deal worth $525M for injectable osteoarthritis pain drug
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.

Shionogi, Grünenthal ink licensing deal worth $525M for injectable osteoarthritis pain drug
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
FDA approves Daiichi Sankyo/Astrazeneca’s Enhertu for HER2 low metastatic breast cancer
The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Innovent, Sanofi to co-develop two oncology drugs in China with €300M investment
Innovent Biologics Inc. has formed a partnership with Sanofi SA to jointly develop and commercialize two of Sanofi’s oncology candidates in combination with sintilimab in China, namely SAR-408701 (tusamitamab ravtansine) and SAR-444245.
Hutchmed planning regulatory submissions on fruquintinib CRC data
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
Sironax raises $200M in series B for RIPK1 inhibitors
Sironax Ltd. has raised $200 million in a series B financing round to support the development of its receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors. The latest financing has brought the capital raised by the Beijing and Shanghai-based company to more than $300 million to date.
Oricell nets $120M in series B round for cell therapies
Oricell Therapeutics Co. Ltd. has raised $120 million in a series B financing to support development of its cell therapy pipeline and technology platform, as well as the construction of a manufacturing plant. The round was jointly led by Qiming Venture Partners and Quan Capital Management LLC.
News in brief
BioWorld Asia briefs for Aug. 9.
Structure Therapeutics nets $33M in financing for GPCR candidates
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
Poseida’s $6B blood relationship with Roche akin to Takeda deal in concept, strategy: CEO
Shares of Poseida Therapeutics Inc. (NASDAQ:PSTX) closed Aug. 3 at $4.51, up $2.08, or 85%, as a result of the collaboration and licensing deal with Roche Holding AG that brings $110 million up front as well as the same amount in near-term milestone payments described by CEO Mark Gergen as “highly achievable,” and the arrangement could be worth as much as $6 billion if goals farther down the road are met.
Researchers reprogram stem cells to uncover new genetic signatures of age-related AMD
Researchers are closer to better diagnosing and treating age-related macular degeneration (AMD) after discovering new genetic signatures of the disease by reprogramming stem cells to generate high-resolution disease models.
Taiwan’s Syneurx gears up for phase III test of COVID-19 oral antiviral
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.

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Analysis and data insight

Taiwan can help biopharma use data more smartly to keep innovation moving
Conferences
Keeping innovation growing at a fast clip while retaining new global supply chain capacity built up during the pandemic were the main topics of discussion at the Bio Asia-Taiwan conference July 27 in Taipei. With the theme of the conference, “Connecting the Asia Value Chain,” Taiwan Vice President...
Despite slow Q2 activity, 2022 deals on top of all recent years
Deals and M&A
Biopharma deals during the second quarter of 2022 fell short of each of the last two years with 379 completed deals valued at $36.9 billion, but the year is still the strongest to date. Thanks to the record-breaking first quarter, deals in the first half of this year are ahead of all other years,...
Infection tops nonprofit deal efforts; U.S. covers 57% of grants
Nonprofit deals with biopharma companies in 2022 indicate that 92% of the disclosed funds are going toward infectious disease therapies, with COVID-19 accounting for 79% of the total.
As world hobbles away from COVID-19, research forges on
Vaccine
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.

Financings

Inventisbio nets ¥2.08B in Shanghai IPO; shares plunge 15.6% on debut
Cancer
Inventisbio Co. Ltd. has raised ¥2.084 billion (US$296 million) in an IPO on Shanghai’s STAR Market priced at ¥18.12 per share, though its stock saw a disappointing debut, opening at ¥14 per share on the first trading day July 25 and closing at $15.29, for a drop of 15.6%. The stock closed Aug. 1...

Australia

Australia’s gene, cell and tissue framework should better align with global peers, stakeholders urge
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.

Radiopharma Clarity touts advantages of its targeted copper theranostics
Newco news
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes,...
Imugene reports positive final overall survival data in phase II HER-Vaxx gastric cancer trial
Clinical
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.

China

Lepu Biopharma anti-PD-1 antibody receives China’s nod for solid tumors
Regulatory
Lepu Biopharma Co. Ltd. has been given conditional approval by China’s NMPA for its anti-PD-1 monoclonal antibody, Puyouheng (pucotenlimab injection), based on data from a phase II study. The drug was conditionally greenlighted for patients with unresectable or metastatic microsatellite...
Genuine Biotech’s azvudine becomes the first China-developed oral drug for COVID-19
Regulatory
Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine...
China’s NMPA grants nod to Hengrui’s AR inhibitor for prostate cancer
Regulatory
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
China issues draft guidelines to speed up cancer drug development via single-arm trials
Clinical
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how...
Akeso wins NMPA approval for dual immune checkpoint inhibitor
Regulatory
Akeso Inc. has been given the green light by China’s NMPA for its PD-1/CTLA-4 antibody Kaitanni (cadonilimab), which was approved for the treatment of patients with relapsed or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy.

Regulatory

ITIF: Japan a cautionary tale for government Rx price controls
Japan
As Democrats in the U.S. Senate rush to pass prescription drug pricing reforms through the reconciliation process this week, the nonpartisan Information Technology & Innovation Foundation (ITIF) is offering Japan’s experience with government price controls as a cautionary tale.

Newco news

Vicebio emerges from stealth with revamped molecular clamp vaccine platform
Vaccine
The technology behind one of the most high profile COVID-19 vaccine development programs has been re-engineered to correct a design fault and now forms the basis of newco Vicebio Ltd. The London-based company has shown its face for the first time following its founding in 2019 around molecular...

Korea’s Medipost builds US, Japan presence for umbilical cord blood stem cells
Inflammatory
South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis.
Chinese biotech Therorna completes $42M series A to develop circRNA COVID-19 vaccines
Vaccine
Chinese biotech company Therorna Inc. completed a $42 million series A round to develop its circular RNA (circRNA) vaccines and therapies.

Science

New analyses conclude that lab origin of SARS-CoV-2 is ‘extremely unlikely’
The controversy about the origins of the SARS-CoV-2 virus and the accusations that it escaped from the Wuhan Institute of Virology, or even that it was deliberately engineered there, could – possibly – be brought to a close by two papers published...
Targeting S2 could lead to broad coronavirus protection
Vaccine
Since the very beginning of the COVID-19 pandemic, in addition to the attempts to rapidly develop a vaccine that was effective against current strains, researchers have been looking for a vaccine that could protect more broadly against multiple...
Taking aim at tumor metabolism, while taming toxicity
Conferences
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in...
Telomere to telomere, the human genome is done
There is a project management joke that the first 90% of a project takes 90% of the time, whereas the last 10% of the project takes the other 90% of the time.
EBV antibodies put to good use through retargeting
Cancer
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11,...
Preprints age well, manuscript preprint shows
One of the most striking recent changes in the dissemination of biomedical science has been the rapid rise of the preprint.

BioWorld Perspectives

U.S. politicking threatens public trust in the FDA and CDC
BioWorld
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to...
When it comes to drug quality, is a ‘C’ acceptable?
BioWorld
In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the...
A decade of incentives to promote antibiotic development and still no viable route to commercial success
BioWorld
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...

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