Immunosuppressants

Bio-Thera Solutions Launches First Commercial Product, QLETLI® (格乐立®), in China

Retrieved on: 
Friday, January 10, 2020
General Health, Health, Science, Pharmaceutical, Research, Drugs, Life sciences, Articles, Immunosuppressants, TNF inhibitors, Monoclonal antibodies, Biotechnology, Biosimilar, Adalimumab, QLETLI®(格乐立®), Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a fully-integrated pharmaceutical company, today announced that QLETLI (), a biosimilar to Humira (adalimumab), is now available in China.

Key Points: 
  • Bio-Thera Solutions, Ltd., a fully-integrated pharmaceutical company, today announced that QLETLI (), a biosimilar to Humira (adalimumab), is now available in China.
  • QLETLI () is Bio-Thera's first biosimilar to receive regulatory approval and is the second biosimilar approved in China by the NMPA.
  • "The commercial launch of Bio-Theras first approved product is an enormous milestone for the company," said Shengfeng Li, Ph.D., CEO of Bio-Thera Solutions.
  • Bio-Thera is committed to bringing additional biosimilar and innovative products to the market in China and around the world."

Samsung Bioepis and AffaMed Therapeutics’ Eculizumab Biosimilar Candidate Receives China IND Approval, Expanding the Ongoing Global Phase 3 Trial

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Friday, January 10, 2020
Health, Medicine, Articles, Immunosuppressants, Eculizumab, Samsung, Rare diseases, Acquired hemolytic anemia, Paroxysmal nocturnal hemoglobinuria, Biosimilar, Hemoglobinuria, Clinical trial

SB12 is developed by Samsung Bioepis for the treatment of paroxysmal nocturnal hemoglobinuria and has responsibility for its global clinical trials conducted across 10 countries.

Key Points: 
  • SB12 is developed by Samsung Bioepis for the treatment of paroxysmal nocturnal hemoglobinuria and has responsibility for its global clinical trials conducted across 10 countries.
  • AffaMed is responsible for SB12 (AMT904)s China NDA approval based on the ongoing global Phase 3 trial conducted by Samsung Bioepis and received exclusive rights to commercialize the treatment in China and Singapore.
  • To date, SB12 (AMT904) is the only biosimilar candidate referencing Soliris (eculizumab) to be granted IND approval in China.
  • The clinical collaboration with AffaMed furthers Samsung Bioepis goal to innovate access to life-changing medicines for patients in need.

Tiziana Reports Phase 1 Clinical Data Demonstrating Oral Treatment with Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, is Well-tolerated in Healthy Volunteers

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Thursday, January 9, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Medical specialties, Medicine, Immunology, RTT, Immunosuppressants, Colitis, Diarrhea, Ulcerative colitis, Fostamatinib, Gemigliptin, Foralumab, Tiziana Life Sciences

Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule.

Key Points: 
  • Each cohort comprised of 4 subjects, of whom 3 received Foralumab treatment and 1 received a placebo capsule.
  • Data from a recently completed clinical study indicated that oral administration of OKT3 was well tolerated at 1 mg/day for 30 consecutive doses in patients with moderate-to-severe ulcerative colitis.
  • Importantly, the treatment resulted in clinical responses in 3 out of 6 patients, including one patient with a complete clinical response.
  • This is the first-ever study demonstrating that orally administered Foralumab is well-tolerated at all doses up to 5.0 mg/dose.

Sorrento Announces Filing for Approval of Infliximab Biobetter Antibody by Its Partner Mabpharm in China

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Monday, January 6, 2020
Medical specialties, Life sciences, Medicine, Biotechnology, Monoclonal antibodies, Immunology, Immune system, Immunosuppressants, Infliximab, Biopharmaceutical, TNF inhibitor, Biosimilar

SAN DIEGO, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm (HK:2181) filed recently a New Drug Application for the Infliximab biosimilar antibody in China.

Key Points: 
  • SAN DIEGO, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm (HK:2181) filed recently a New Drug Application for the Infliximab biosimilar antibody in China.
  • Sorrento plans to file a Biologics License Application (BLA) for the Infliximab biobetter antibody in the United States in 2020.
  • Sorrento, through a global licensing agreement with Mabpharm, owns the global rights to the Mabpharm Infliximab biobetter antibody outside of China.
  • Mabpharm recently submitted a new drug application with the National Medical Products Administration (the NMPA) for a recombinant anti-TNF-alpha chimeric monoclonal antibody based on infliximab.

Principia Updates PRN1008 Pemphigus Clinical Program

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Monday, December 30, 2019
Organ systems, Medical specialties, Medicine, Autoimmune diseases, Rare diseases, Pemphigus, Bruton's tyrosine kinase, Immune thrombocytopenic purpura, Immunosuppressants, Fostamatinib

Principia is currently enrolling patients in a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial, the PEGASUS study, in approximately 120 patients to evaluate PRN1008 versus placebo using a background treatment of tapering doses of CS.

Key Points: 
  • Principia is currently enrolling patients in a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial, the PEGASUS study, in approximately 120 patients to evaluate PRN1008 versus placebo using a background treatment of tapering doses of CS.
  • For more information on the PRN1008 pemphigus trials, please visit the Patients section of Principias website.
  • Principia believes this approach limits systemic exposure of PRN1008 and enables rapid clinical reversibility of effects on the immune system and is thus designed for use as a chronic therapy in immune-mediated diseases.
  • PRN1008, a reversible covalent BTK inhibitor, is being evaluated in a Phase 3 clinical trial in patients with pemphigus, an orphan autoimmune disease, and in a Phase 2 clinical trial in patients with immune thrombocytopenia (ITP), a rare hematological disease.

Clover Biopharmaceuticals Initiates Phase III Study of Etanercept Biosimilar Candidate SCB-808 in China

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Monday, December 30, 2019
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Medicine, Health, Arthritis, Immunosuppressants, TNF inhibitors, RTT, Axial spondyloarthritis, Ankylosing spondylitis, Etanercept, Biopharmaceutical, Spondyloarthropathy

The Phase III, multi-center trial in China is designed to assess the efficacy, safety and pharmacokinetics of SCB-808 and originator drug Enbrel in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) via subcutaneous administration.

Key Points: 
  • The Phase III, multi-center trial in China is designed to assess the efficacy, safety and pharmacokinetics of SCB-808 and originator drug Enbrel in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) via subcutaneous administration.
  • The treatment of ankylosing spondylitis and other rheumatic diseases remains a high unmet medical need in China, as the majority of patients remain severely undertreated.
  • We are excited to work with Dr. Huang and these world-class investigators and sites participating in this study, said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover.
  • Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases.

Starton Successfully Completes Proof of Concept Study for Transdermal Lenalidomide

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Friday, December 27, 2019
Drugs, Medicine, RTT, Clinical medicine, Immunosuppressants, Lenalidomide, Chronic lymphocytic leukemia, Multiple myeloma, Tumors of the hematopoietic and lymphoid tissues, CLL

NEW YORK, Dec. 27, 2019 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (Starton or the Company), a biotechnology company focused on transforming standard of care therapeutics, today announced the completion of a proof of concept study of multiple myeloma with lenalidomide using a model which emulates transdermal delivery.

Key Points: 
  • NEW YORK, Dec. 27, 2019 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (Starton or the Company), a biotechnology company focused on transforming standard of care therapeutics, today announced the completion of a proof of concept study of multiple myeloma with lenalidomide using a model which emulates transdermal delivery.
  • The positive outcome provides a clear path for development of transdermal lenalidomide in hematologic malignancies including multiple myeloma and chronic lymphocytic leukemia.
  • "Startons 7-day lenalidomide may be particularly valuable for the CLL patient population where lenalidomide is recommended by NCCN guidelines but is lacking FDA approval.
  • Starton uses proven transdermal technology with proprietary drivers to obtain new indications or develop on-label superiority.

AbbVie Receives European Commission Approval of RINVOQ™ (upadacitinib) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Retrieved on: 
Wednesday, December 18, 2019
Medical specialties, Medicine, Clinical medicine, RTT, Immunosuppressants, Rheumatology, Anti-inflammatory agents, Organofluorides, Upadacitinib, Methotrexate, Rheumatoid arthritis, Arthritis

"We are proud to offer this once-daily tablet as a new treatment option for patients with moderate to severe active rheumatoid arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie.

Key Points: 
  • "We are proud to offer this once-daily tablet as a new treatment option for patients with moderate to severe active rheumatoid arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie.
  • If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
  • Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study.
  • A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Nave Patients with Active Rheumatoid Arthritis.

​NeuClone Completes Dosing in Phase I Clinical Trial of Stelara® (ustekinumab) Biosimilar Candidate

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Wednesday, December 18, 2019
Biotechnology, Pharmaceutical, Health, Clinical trials, Life sciences, Articles, Health, Biotechnology, Pharmaceutical industry, Immunosuppressants, Monoclonal antibodies, Biosimilar, Drugs, Biopharmaceutical, Clinical trial, Ustekinumab, NeuClone, the NeuClone and Serum Institute Partnership

NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced successful recruitment and dosing of all subjects in the Phase I clinical trial for its Stelara (ustekinumab) biosimilar candidate, NeuLara.

Key Points: 
  • NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced successful recruitment and dosing of all subjects in the Phase I clinical trial for its Stelara (ustekinumab) biosimilar candidate, NeuLara.
  • We are very excited to see faster than anticipated enrolment of subjects into our NeuLara Phase I clinical trial, stated Dr Noelle Sunstrom, CEO and Founder of NeuClone.
  • NeuLara is one of several biosimilars developed in partnership between NeuClone and Serum Institute of India Pvt Ltd (Serum Institute).
  • NeuClone develops biosimilar products using its proprietary NeuMAX platform that facilitates low-cost manufacture of biologics, while enabling the highest product quality.

Meiji Seika Pharma and Dong-A Socio Holdings Initiate Phase I Clinical Trial of DMB-3115, a Ustekinumab Biosimilar Candidate

Retrieved on: 
Monday, December 16, 2019
Biotechnology, Pharmaceutical, Health, Clinical trials, Monoclonal antibodies, Immunosuppressants, Life sciences, Biotechnology, Articles, Janssen Biotech, Ustekinumab, Meiji Seika, Biosimilar, Medicine

Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, Meiji) and Dong-A Socio Holdings Co., Ltd. (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, Dong-A) today announced the initiation of a Phase I clinical trial of DMB-3115.

Key Points: 
  • Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi, Meiji) and Dong-A Socio Holdings Co., Ltd. (Headquarters: Seoul, Korea, CEO: Jong Hyun Han, Dong-A) today announced the initiation of a Phase I clinical trial of DMB-3115.
  • The Phase I clinical trial is a randomized double-blind, three-arm, single-dose study to compare pharmacokinetics, safety and tolerability of DMB-3115 with its reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers at a single site in Europe.
  • The dosing for subjects in the study was started on 13 December.
  • Meiji and Dong-A are developing DMB-3115 as a biosimilar candidate to ustekinumab, a recombinant immunoglobulin G1kappa monoclonal antibody targeting interleukin (IL)-12 and IL-23.