Bevacizumab

Breakthroughs in Kexing Biopharm's Overseas Efforts: Qualification of Two Licensed Products for GMP Audits in Egypt

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星期二, 四月 2, 2024
Ulcerative colitis, Psoriasis, Rheumatoid arthritis, Growth, Ankylosing spondylitis, Drug, EDA, Ageing, Kingdom Holding Company, Crohn's disease, Lung cancer, GMP, Bevacizumab, Infliximab, Pharmaceutical industry

In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.

Key Points: 
  • In 2022, Kexing Biopharm secured agreements with 24 overseas market customers and commenced the submission of local drug access registration documents.
  • The product underwent GMP audits in Egypt, Brazil, and Indonesia respectively in September 2023, February 2024, and March 2024.
  • In 2022, Kexing Biopharm swiftly reached agreements with 23 overseas market customers, initiating the submission of drug access registration documents.
  • By establishing local subsidiaries, Kexing Biopharm strives to accelerate product registration processes and enhance competitiveness in overseas markets.

Essex Bio-Technology Posts Sound 2023 Annual Financial Results, Revenue Up 29.5%, Profit Up 22.1%

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星期一, 三月 18, 2024
Cloud, Research, SKQ1, Quality control, Weather, NMPA, Therapeutic Goods Administration, Environment, Best, Intelligence, Patent, Patient, Conditional sentence, Ophthalmology, Hospital, POCT, Acquisition, CMC, European Medicines Agency, GMP, City, QMS, Bevacizumab, Chemistry, Yoy, US FDA, Traction, Good, Therapy, Point-of-care testing, VISTA, Pharmaceutical industry

The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.

Key Points: 
  • The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.
  • As of 31 December 2023, the Group had cash and cash equivalents of approximately HK$509.8 million (2022: approximately HK$543.5 million).
  • Together with the interim dividend of HK$0.045 per ordinary share paid on 13 September 2023, the total dividend for 2023 would be HK$0.09 (2022: HK$0.065) per ordinary share.
  • The Group's turnover is primarily made up of the ophthalmology segment ("Ophthalmology") and surgical (wound care and healing) segment ("Surgical").

Tempest Reports New Preclinical Data for TPST-1120 in RCC at the AACR Annual Meeting

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星期二, 四月 9, 2024
HCC, Head, Growth, Immunotherapy, Patient, Tumor microenvironment, Cancer, Renal cell carcinoma, AACR, Bevacizumab, RCC, Neoplasm, Therapy, Nivolumab, ASCO, Tempest, Kidney cancer

These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.

Key Points: 
  • These new data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.
  • “Preclinical data presented at AACR further demonstrate that TPST-1120 has the potential to positively transform the tumor microenvironment and expand the activity of anti-tumor immunity in kidney cancer,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest.
  • In preclinical models of renal cell carcinoma (RCC), treatment with TPST-1120 reduced tumor growth by 52%-56% as monotherapy.
  • Additional improvement in anti-cancer activity was demonstrated in combination treatment with standard first-line RCC cabozantinib or anti-PD1 therapy, where tumor inhibition was 81% and 74%, respectively.

Cardiff Oncology Presents Novel Preclinical Data at AACR Annual Meeting 2024 that Supports Ongoing First-line RAS-mutated mCRC Clinical Study

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星期一, 四月 8, 2024
Ovarian cancer, Cetuximab, CRDF, RAS, Patient, Bev, PLK1, Abstract, AACR, Bevacizumab, Cancer, Phase, Data, SCLC, Pharmaceutical industry

In combination, the abstracts underscore the significant potential of the company’s lead molecule onvansertib in metastatic colorectal cancer (mCRC) and other cancers.

Key Points: 
  • In combination, the abstracts underscore the significant potential of the company’s lead molecule onvansertib in metastatic colorectal cancer (mCRC) and other cancers.
  • In addition, we are particularly encouraged by our RAS-mutated mCRC preclinical data highlighting onvansertib’s ability to inhibit activation of the hypoxia pathway via the regulation of HIF1α.
  • All the abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR.
  • Following the presentation, the posters will be posted to the “ Scientific Presentations ” section of the Cardiff Oncology website.

Tempest Announces Publication of Positive Data from Phase 1 Trial of TPST-1120 in Patients with Advanced Solid Tumors in Journal of Cancer Research Communications

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星期四, 四月 4, 2024
HCC, Combination therapy, Nivolumab, Head, Patient, Bevacizumab, Therapy, Cancer, PD-1, Pharmaceutical industry

These earlier Phase 1 data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, which showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations.

Key Points: 
  • These earlier Phase 1 data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, which showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations.
  • “In this Phase 1 study of TPST-1120, we saw the first evidence of anti-tumor activity in multiple cancer types, affirming our belief that PPARα inhibition is an exciting and novel approach for cancer treatment,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest.
  • “These early-phase data are supported by the positive top line results of the ongoing randomized Phase 1b/2 trial in first-line HCC.
  • We believe there is tremendous potential for TPST-1120 to make a meaningful impact for patients and we look forward to providing updated data this year.”

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

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星期五, 三月 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

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星期一, 三月 25, 2024
Research, FASN, Fatty liver disease, Congress, Exercise, Progression-free survival, F2, Patient, SAN, Food and Drug Administration, F3, G&A, IPO, Obesity, IND, Acne, Bevacizumab, Glioblastoma, Fibrosis, Clinical trial, NASH, FDA, Drug development, Pharmaceutical industry

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • In January 2024, Sagimet sold 9,000,000 shares of its Series A common stock in an underwritten public offering and received $104.7 million in net proceeds.
  • In November 2023, Sagimet presented preclinical data evaluating denifanstat alone or in combination with semaglutide in mouse models of MASH at the 7th Obesity and NASH Drug Development Summit.
  • In October 2023, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany.
  • In July 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share.

Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

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星期五, 三月 22, 2024
Retina, Civil service commission, Committee, EMA, European Medicines Agency, Bevacizumab, European, Outlook, Therapy, European Commission, AMD, Marketing, CHMP, Pharmaceutical industry

Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.

Key Points: 
  • Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
  • “The CHMP positive opinion for ONS-5010/LYTENAVA™ represents a significant milestone for Outlook Therapeutics and advancement in the treatment of wet AMD in the EU.
  • If approved, an initial ten years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA™.
  • The CHMP’s positive opinion supports the grant of marketing authorization by the European Commission (EC) for Outlook Therapeutics’ application for ONS-5010.

NuCana Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Business Update

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星期三, 三月 20, 2024
Lung cancer, Apoptosis, Docetaxel, FOLFIRI, Irinotecan, Immunotherapy, Progression-free survival, Patient, Lung, Dicarboxylic acid, Standard of care, Cancer, Bevacizumab, Melanoma, NCNA, Therapy, PFS, Pharmaceutical industry

EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.

Key Points: 
  • EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.
  • As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022.
  • NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022.
  • Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022.

Tempest Reports Year End 2023 Financial Results and Provides Business Update

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星期二, 三月 19, 2024
Research, OS, NCI, Mutation, EP4, Gene expression, Immunotherapy, RECIST, Patient, National Cancer Institute, Pembrolizumab, Society, AACR, Bevacizumab, Therapy, Nivolumab, ASCO, EP2, SITC, PFS, Liver cancer, FDA, Pharmaceutical industry

“2023 was a transformative year for Tempest.

Key Points: 
  • “2023 was a transformative year for Tempest.
  • We announced strong positive randomized data showing the benefit of TPST-1120 combination therapy compared to standard-of-care in first-line liver cancer,” said Stephen Brady, president and chief executive officer of Tempest.
  • Tempest ended the year with $39.2 million in cash and cash equivalents, compared to $31.2 million on December 31, 2022.
  • Based on current cash and operating plan, Tempest expected to have sufficient resources to fund operations into the second quarter of 2025.