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BioWorld - Tuesday, May 17, 2022
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  • China U.S. deal

    Merck acquires global rights to cancer drug from Kelun in $1.4B deal

    In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
  • F2G finds partner for antifungal olorofim in $480M Shionogi deal

  • Taiho goes Pearl diving, brings up $405M Cullinan deal

  • Zhaoke licenses Asian rights to Visus presbyopia candidates in $130M deal

  • Zhifei Lvzhu wins rights to whooping cough vaccine from Intravacc

  • News in brief

  • Merck acquires global rights to cancer drug from Kelun in $1.4B deal

    In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
  • F2G finds partner for antifungal olorofim in $480M Shionogi deal

    Antifungals specialist F2G Ltd. has signed an agreement with Japanese pharma Shionogi & Co. Ltd. for development and commercialization of its treatment for invasive aspergillosis in both Asia and Europe. Under the terms of the deal, F2G is getting $100 million up front and regulatory and commercialization milestones of up to $380 million. The two partners will share clinical development costs.
  • Taiho goes Pearl diving, brings up $405M Cullinan deal

    Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
  • Zhaoke licenses Asian rights to Visus presbyopia candidates in $130M deal

    Visus Therapeutics Inc. has out-licensed phase III candidates Brimochol and Carbachol to Hong Kong’s Zhaoke Ophthalmology Ltd. to develop and commercialize its long-acting, presbyopia-correcting eye drops in greater China, South Korea and select Southeast Asian territories.
  • Zhifei Lvzhu wins rights to whooping cough vaccine from Intravacc

    Beijing Zhifei Lvzhu Biopharmaceutical Co. Ltd. has picked up rights to a whooping cough vaccine candidate from Intravacc B.V. on undisclosed terms. Zhifei Lvzhu gained exclusive rights to develop and commercialize the vaccine in China, as well as nonexclusive rights in Africa, South America, and selected Asian countries. In turn, Intravacc is eligible to receive milestone and up-front payments plus royalties on net sales of the vaccine, should it reach market.
  • News in brief

    BioWorld Asia briefs for May 17.
  • BioKorea 2022: As microbiome therapies emerge, leaders see challenges, opportunities

    Microbiome-modulating therapies are increasingly being explored to treat a variety of diseases. However, the market is still in its infancy and a lack of solid regulations remains challenging for companies to overcome, speakers at the BioKorea 2022 said May 11.
  • Orion picks up rights to Jemincare non-opioid pain drug in €15M deal

    Orion Corp. has secured exclusive global rights, outside China, to a non-opioid pain drug candidate from Jiangxi Jemincare Group Co. Ltd. The deal, for oral sodium channel inhibitor JMKX-000623, brought Jemincare €15 million (US$15.6 million) up front. 
  • BioKorea 2022: Key to predicting next pandemic lies in infectious diseases’ zoonotic component

    As the COVID-19 pandemic slowly starts to ease globally, efforts are already gearing up to predict the next potential pandemic. One institute researching the increasing number of diseases transmitted from animals to humans is Canada’s Vaccine and Infectious Disease Organization, part of the University of Saskatchewan.
  • The trouble with TIGITs: Genentech’s failure sparks worry across class

    A phase III failure for Roche Holding AG unit Genentech Inc.'s anti-TIGIT immunotherapy tiragolumab dragged down the share value of several other class entrants. 

BioWorld Insider Podcast

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Analysis and data insight

  • Global vaccine illustration

    As COVID numbers drop, biopharma research remains steadfast

    Vaccine
    For the first time since the early weeks of the COVID-19 pandemic in 2020, global deaths caused by the disease have fallen to their lowest point, as immunity against the SARS-CoV-2 virus and its variants continues to build. Infections and deaths appear to be decelerating, an optimistic sign that...
  • Handshake in office setting

    Biopharma deal values rise by 36% in Q1, while M&As are at lowest point

    Deals and M&A
    Although efforts focused on COVID-19 continue to fade and there are fewer collaborations than in previous years, the biopharma industry has recorded record value from mega-deals in the first quarter (Q1) of 2022, topping all recent years, as executives continue to opt against costly mergers and...
  • Biopharma financings in Q1 at lowest point since 2017

    Financings
    Biopharma financings for the first quarter of 2022 are at a five-year low, with 65.8% less money and 53% fewer transactions than a year ago. The industry raised $13.1 billion through 249 financings, compared with $38.3 billion from 529 transactions in 2021.
  • Globe and currency symbols

    Final tally comes in at $118B, second top financings amount in biopharma history

    Financings
    While the $118.3 billion raised by biopharma companies in 2021 through public and private transactions is 12% lower than the amount raised the prior year, it still represents an impressive financings record, led primarily by IPOs and venture capital rounds.
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 17, 2022

  • Conference data for April 12-18, 2022: AACR

  • Financings for May 10, 2022

  • In the clinic for May 10-16, 2022

  • Other news to note for May 17, 2022

  • Regulatory actions for May 10-16, 2022

Deals and M&A

  • Juniper acquires infigratinib rights from Helsinn in emerging markets

  • Hansoh wins greater China rights to oncology drug from Nikang in $218M deal

  • Awake at the wheel: Jazz buys Sumitomo sleep disorder candidate in $1.14B deal

  • Ashvattha lands $69M series B, Huadong licensing deal

  • Xbiome acquires drug from Assembly Biosciences to treat ulcerative colitis

  • SK Biopharmaceuticals and Ubix to develop cancer treatments using targeted protein degradation

  • Teijin and JCR quit joint development of stroke therapy as ‘new chapter’ unfolds

  • Bridge Biotherapeutics inks ₩30B deal with Shaperon for GPCR19 agonist

  • Genequantum collaborates with Aimed Bio to develop ADC for brain tumors

  • Juniper Biologics acquires gene therapy for knee osteoarthritis in $600M deal from Kolon Life Science

Financings

  • Antibodies attacking cancer cell

    Askgene’s series A adds $20M for cytokine fusion, antibody pipeline

    Cancer
    Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of...
  • Pepgen and B&L join a struggling IPO market

    Neurology/Psychiatric
  • NEC Oncoimmunity bags $4.8M to develop vaccines for SARS-CoV-2 variants, other betacoronaviruses

    Infection
  • Antibody firm Remegen raises $410M in Shanghai IPO, but stock tumbles

    Antibody-drug conjugate
  • Recbio raises HK$765M in Hong Kong IPO, shares rise 1.8% on first trading day

    Vaccine
More in Financings
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Australia

  • Map of Australia as blue circuit board, digital network

    Australia to begin routine GCP inspections for clinical trial sites

    Clinical
    Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would...
  • Australia to allow imports of overseas medicines to mitigate drug shortages

    Regulatory
    Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian...
  • Telix in-licenses Lilly’s failed olaratumab in deal worth up to $225M

    Deals and M&A
    Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
  • TGA: More feedback needed on repurposing drugs

    Regulatory
  • Australia introduces patent box legislation for med-tech and biotech innovations

    Regulatory
  • Australian National Medicines Policy consultation process causes industry uproar

    Regulatory
  • New Zealand’s Pharmac funds 13 new drugs, widens access to 19

    Regulatory
More in Australia

China

  • Esophageal cancer

    Beigene’s tislelizumab meets primary survival endpoint in first-line advanced esophageal cancer

    Clinical
    Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
  • RNA

    Arrowhead and Vivo co-launch firm in China with $60M investment

    Newco news
    Arrowhead Pharmaceuticals Inc. and Vivo Capital LLC have launched a joint venture named Visirna Therapeutics for RNA interference therapeutics in the greater China market. Arrowhead is the majority shareholder of the new entity, while Vivo invested $60 million in the new entity.
  • China-flag-regulatory.png

    China’s NMPA approves Pfizer’s third-generation ALK inhibitor Lorbrena in NSCLC

    Regulatory
    China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
  • Beigene’s zanubrutinib meets primary endpoints in phase III trial to treat chronic lymphocytic leukemia

    Clinical
    Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
  • DNA illustration

    China clarifies regulations on sharing human genetic resources

    Clinical
    China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
More in China

Clinical

  • As space muscles up, Wall Street tries to separate the menin from the noise

  • Connect seeks to partner S1P drug after phase II falls short

  • Shionogi releases positive results, back on track for COVID-19 treatment

  • With positive phase III Tibsovo data, Servier and Cstone targeting AML

  • US booster study next after Arcturus’ self-amplifying mRNA COVID-19 vaccine hits endpoints

  • Shionogi’s COVID treatment could disturb fetal development, impact regulatory approval

  • Ontak making a comeback with new data from Citius

  • Ark Bio shares positive data for first positive RSV antiviral phase III

  • Allist's furmonertinib meets primary endpoint in phase III trial to treat lung cancer

  • Phase III proxalutamide opens door for Kintor in COVID-19

Regulatory

  • Global vaccine.png

    WTO’s IP waiver reaches final stretch

    Drugs
    A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
  • CRLs make week's start rough start for four companies

    Cancer
  • Turkey disputes WTO findings, US 301 calls out the same bad actors

    Europe
  • Japan’s annual drug price reforms result in less predictability for pharma market

    Drugs
  • China issues new audit rules and weighs giving U.S. regulators full access to audits

    China
More in Regulatory
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Newco news

  • Gold dollar sign inside gold cog

    Chimera going for ‘Gold’ as AFCR award boosts funding round

    Cancer
    Chimera Bioengineering Inc. has been selected as the winner of the Asian Fund for Cancer Research's (AFCR) 2021 BRACE Award Venture Competition, contributing $500,000 as part of a recent $7.5 million capital infusion and bringing to $26 million the company’s total amount raised to date.
  • ‘Endo’ the line for CESED? Aurion cell therapy raises $120M

    Ocular
    Aurion Biotech Inc. pulled down a $120 million financing to advance efforts with its lead candidate, a cell therapy for the treatment of corneal edema secondary to endothelial dysfunction (CESED).
  • On heels of $70M series B round, China’s Medilink Therapeutics poised to enter clinic with ADC pipeline

    Cancer
    After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs).
  • Aevisbio and NIH work to tackle neuroinflammation in Alzheimer's disease

    Neurology/Psychiatric
  • Prota Therapeutics achieves clinical remission of peanut allergy in phase IIb trial

    Clinical
  • Servatus advances live microbial biotherapeutics after AU$7.5M capital raise

    Immune
  • Binhui moves HSV-2-based oncolytic viral candidate toward U.S. trial

    Clinical
More in Newco news

Science

  • 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.
  • British Pakistani genomics study illustrates need for diversity

    Europe
    It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of...
  • B-cell GABA release blunts tumor immune response

    Cancer
    Immune system B cells secrete the neurotransmitter gamma amino-butyric acid (GABA), which promotes generation of anti-inflammatory macrophages and blunts the cytotoxic T cell-based response to tumors in mice.
More in Science

BioWorld Perspectives

  • Health care and politics illustration

    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...
  • C grade on notebook paper

    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...
  • Capsules in blister packs

    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...
  • U.S. money

    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...
More in BioWorld Perspectives

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