Adagene Secures $69M Series D Financing; Keytruda Approved for High-Risk Bladder Cancer; CSPC’s Pregabalin Capsule Launches in U.S.
Adagene Completes $69 Million Series D Financing to Advance Clinical Development of Immunotherapy Candidates
On January 8, 2020, Adagene announced the completion of a $69 million Series D financing round, led by General Atlantic with a $50 million investment. The proceeds will be used to advance the development of its immuno-oncology clinical programs and to further expand its proprietary innovative technologies. Since 2014, Adagene has raised over $150 million in capital from global financial markets.
Tarsus Pharmaceuticals Completes $60 Million Series B Financing to Launch Clinical Trials of Lead Candidate TP-03
On January 8, 2020, biopharmaceutical company Tarsus Pharmaceuticals completed a $60 million Series B financing round. The round was led by Vivo Capital, with participation from Frazier Healthcare Partners, Flying L Partners, Visionary Ventures, Aperture Venture Partners, and Horowitz Group. Tarsus Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company headquartered in Irvine, California. Founded in 2017, the company aims to apply innovative therapies to a range of diseases in need of better solutions, starting with demodex blepharitis and eye care, and is dedicated to developing the first-ever drug for blepharitis.
NorthSea Secures $40 Million in Series B Funding to Support Phase 2 Study of Icosabutate in NASH Patients
On January 9, 2020, Dutch biopharmaceutical company NorthSea Therapeutics announced the completion of a $40 million Series B financing round. The funds will be primarily used for the Phase 2b clinical trial, ICONA, evaluating its first-in-class orally administered structurally engineered fatty acid (SEFA) drug, icosabutate, in patients with non-alcoholic steatohepatitis (NASH).
Aegle Therapeutics Secures $4 Million in Funding to Advance Clinical Trials of Stem Cell-Derived Exosomes
Aegle Therapeutics recently announced that it has secured $4 million in investment, led by New World Angels and joined by Tellus BioVentures, DEFTA Healthcare Technologies, DeepWork Capital, and others, to advance clinical trials of its pioneering stem cell-derived exosomes for dystrophic epidermolysis bullosa (DEB), a rare pediatric blistering skin disease.
Merck’s PD-1 Inhibitor Keytruda Approved by FDA for Treatment of Patients with Specific High-Risk Bladder Cancer
On January 9, 2020, the FDA announced the approval of Merck & Co.’s (MSD) blockbuster PD-1 inhibitor Keytruda for the treatment of patients with specific high-risk non-muscle-invasive bladder cancer (NMIBC). These patients have carcinoma in situ (CIS), are unresponsive to bacillus Calmette-Guérin (BCG) therapy, and are unwilling or unable to undergo cystectomy. Merck’s press release stated that this is the first PD-1 inhibitor approved for the treatment of such patients.
CSPC’s Abbreviated New Drug Application (ANDA) for Pregabalin Capsules Approved by the FDA
Recently, CSPC Pharmaceutical Group announced that the Abbreviated New Drug Application (ANDA) for its Pregabalin Capsules has been approved by the U.S. Food and Drug Administration. Pregabalin is a structural derivative of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. It works by blocking voltage-gated calcium channels, thereby reducing the release of neurotransmitters. Clinically, it is primarily used for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, as adjunctive therapy for partial-onset seizures in adults, generalized anxiety disorder, neuropathic pain following spinal cord injury, and fibromyalgia.
Zhongsheng Pharmaceutical’s Dextromethorphan Hydrobromide Tablets for Cough Become the First to Pass Generic Drug Consistency Evaluation
On January 9, Zhongsheng Pharmaceutical issued an announcement stating that its wholly-owned subsidiary, Huanan Pharmaceutical, had recently received the "Approval Document for Supplementary Drug Application" (Approval No.: 2019B04697) approved and issued by the National Medical Products Administration (NMPA). It is reported that no other domestic enterprises have currently submitted applications for the consistency evaluation of quality and efficacy for generic dextromethorphan hydrobromide products. Huanan Pharmaceutical is the only enterprise in China to have passed the supplementary application review under the policy for consistency evaluation of quality and efficacy for generic dextromethorphan hydrobromide tablets. Dextromethorphan hydrobromide tablets are an over-the-counter (OTC) antitussive medication, classified as a Class A OTC drug, indicated for dry cough, including coughs caused by upper respiratory tract infections (such as the common cold and pharyngitis), bronchitis, and other conditions.
AbbVie’s Oral JAK1 Inhibitor Rinvoq Approved by Health Canada
Recently, AbbVie, the U.S. biopharmaceutical giant, announced that Health Canada has approved the JAK1 inhibitor Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to or intolerance of methotrexate (MTX). This once-daily oral selective and reversible JAK inhibitor can be used as monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
FDA Approves Expansion of Astellas’ Micafungin Indication to Include Infants Under 4 Months of Age
Recently, Astellas announced that the FDA has approved a supplemental new drug application for Mycamine (micafungin injection) for use in infants under 4 months of age to treat candidemia without meningitis and/or ocular involvement, acute disseminated candidiasis, candidal peritonitis, and abscesses.
Aruvant’s Fetal Hemoglobin Gene Therapy ARU-1801 Receives FDA Rare Pediatric Disease Designation
Recently, Aruvant Sciences, a subsidiary of Roivant Sciences, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ARU-1801 for the treatment of sickle cell disease (SCD). ARU-1801 is an improved fetal hemoglobin gene therapy developed for sickle cell disease (SCD) and related hemoglobinopathies, such as beta-thalassemia.
Blueprint Announces Pivotal Clinical Trial of RET Inhibitor Pralsetinib for NSCLC
On January 9, 2020, Blueprint Medicines announced positive topline results from the Phase 1/2 ARROW clinical trial of pralsetinib (BLU-667), a highly selective RET inhibitor, in patients with RET fusion-positive non-small cell lung cancer (NSCLC). Blueprint Medicines has initiated a rolling New Drug Application (NDA) submission to the U.S. FDA for this indication and expects to complete the submission in the first quarter of this year. Additionally, the company plans to submit another NDA for pralsetinib in the second quarter of this year for the treatment of patients with medullary thyroid cancer (MTC) who have previously received multi-kinase inhibitor therapy.
Conde Biopharma Announces Positive Results from Phase 1b Clinical Study of Innovative Drug CBP-201 for the Treatment of Moderate-to-Severe Atopic Dermatitis
Recently, Connexin Biosciences announced significant progress in its R&D pipeline: its novel IL-4Rα antibody drug, CBP-201, demonstrated positive clinical results in a Phase 1b study conducted in Australia and New Zealand involving patients with moderate-to-severe atopic dermatitis. Compared with clinical data for Dupixent, the current standard of care for eczema, CBP-201 exhibited superior efficacy after four weeks of treatment, along with a favorable safety profile. CBP-201 is a high-potency anti-IL-4Rα monoclonal antibody.
WuXi Biologics and Almirall Sign Strategic Collaboration Agreement to Develop Multiple Bispecific Antibodies for Dermatological Therapies
On January 9, 2020, WuXi Biologics, a globally leading open-access biologics technology platform company, and Almirall, an international pharmaceutical company focused on skin health, jointly announced the signing of a strategic collaboration agreement to develop multiple innovative bispecific antibodies for the treatment of dermatological diseases. Under the terms of the agreement, Almirall has been granted licenses to utilize several antibody technology platforms with independent intellectual property rights owned by WuXi Biologics. WuXi Biologics will receive upfront licensing fees, milestone payments tied to product development, regulatory approval, and commercialization, as well as sales royalties based on global net sales after product launch.
Verastem and Chugai Reach Exclusive Licensing Agreement for RAF/MEK Inhibitor to Treat Solid Tumors
On January 9, 2020, Verastem Oncology announced that it had entered into an exclusive global licensing agreement with Japan’s Chugai Pharmaceutical Co., Ltd., granting Verastem the global rights to develop and commercialize CH5126766 (CKI27), a RAF/MEK inhibitor developed by Chugai. Currently, CH5126766 is being developed for the treatment of patients with solid tumors harboring KRAS mutations. Under the terms of the agreement, Verastem will be responsible for the development and global commercialization of CH5126766, and will pay Chugai a $3 million upfront payment, as well as future sales royalties on CH5126766.
Universal Sequencing Launches TELL-Seq Whole Genome Sequencing Library Preparation Kit
Recently, Universal Sequencing Technology officially launched its first product—the TELL-Seq Whole Genome Sequencing Library Preparation Kit—which enables researchers to extract long-range information from short-read sequencing data. Reportedly, this whole-genome library preparation kit employs a transposase to fragment DNA and add barcodes, thereby facilitating the reassembly of reads after sequencing. The kit can be used to generate pseudo-long reads with an average length of 50 kb and a maximum length of 100 kb. It supports library preparation for up to four large genomes or 12 smaller genomes in a single run, and is priced at $720.
Australia Trials Free Genetic Testing for Prospective Parents, Covering Over 700 Rare Genetic Disorders
Australia Trials Free Genetic Testing for Expectant ParentsRecently, Australia has been piloting free genetic testing for expectant parents. Funded by the government, this initiative offers screening for over 1,300 genetic variants associated with more than 700 rare hereditary diseases to participating parents.
Hong Kong Enters Winter Influenza Season, with Influenza A(H1N1) Accounting for 66.3%
On January 9, the Centre for Health Protection of Hong Kong announced that the activity level of seasonal influenza in Hong Kong continued to rise last week and exceeded the baseline threshold, indicating that Hong Kong has entered the 2019/2020 winter influenza season. The Centre pointed out that over the past two weeks, the predominant circulating influenza viruses were influenza A(H1) (accounting for approximately 66.3%) and influenza A(H3) (accounting for approximately 30.4%).