NMPA

Cyclica and IMPACT Therapeutics Team Up to Advance Differentiated Anti-cancer Drug Development

Wednesday, September 22, 2021 - 2:37pm

Cyclica, the partner of choice for data-driven drug discovery, and IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics with synthetic lethality approach, announce today that they have entered to a collaboration agreement on IMPACT Therapeutics differentiated targeted anti-cancer drug development.

Key Points: 
  • Cyclica, the partner of choice for data-driven drug discovery, and IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics with synthetic lethality approach, announce today that they have entered to a collaboration agreement on IMPACT Therapeutics differentiated targeted anti-cancer drug development.
  • IMPACT Therapeutics will apply Cyclicas Ligand Express platform to selectively understand the targetivity profile of its novel anticancer therapeutics.
  • The insights gained from such a collaboration will further improve and validate IMPACT Therapeutics competitive advantage in its clinical candidate.
  • To learn more about Cyclica and how we partner, please visit www.cyclicarx.com
    IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality.

Global Virtual Clinical Trials Markets, 2021-2028 by Study Design (Interventional, Observational, Expanded Access), & Indication (Oncology, Cardiovascular) - ResearchAndMarkets.com

Tuesday, September 21, 2021 - 1:33pm

The "Global Virtual Clinical Trials Market Size, Share & Trends Analysis Report 2021-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Virtual Clinical Trials Market Size, Share & Trends Analysis Report 2021-2028" report has been added to ResearchAndMarkets.com's offering.
  • The global virtual clinical trials market size is expected to reach USD 11.5 billion by 2028 and is expected to expand at a CAGR of 5.7% from 2021 to 2028.
  • The need for patient diversity clubbed with enhanced data collection in clinical trials is boosting virtual/decentralized clinical trials (DCTs) market growth.
  • Virtual clinical studies eliminate challenges posed by traditional research studies, for example, delays in patient recruitment and time-consuming procedures.

BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical Oncolo

Monday, September 20, 2021 - 12:30pm

ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m.

Key Points: 
  • ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m.
  • This includes the final intention-to-treat (ITT) dataset from the Companys DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type.
  • Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.
  • The DUBLIN-3 Phase 3 trial is a randomized, active controlled, single blind to patients, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with a measurable lung lesion.

Junshi Biosciences Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19

Sunday, September 19, 2021 - 12:29pm

The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.

Key Points: 
  • The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.
  • Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Sciences.
  • Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.
  • Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine

Friday, September 17, 2021 - 2:00pm

LAWRENCEVILLE, N.J. and HAINAN, China, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, today announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.

Key Points: 
  • Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsions vaccine based on its TheraPlas technology.
  • Madame Fang, chief executive officer of Hainan Poly Pharm said, Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience.
  • Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing clinical batches of GEN-1 to support Celsions OVATION 2 Study in advanced ovarian cancer.
  • Commenting on the agreement, Michael Tardugno, chairman, president and chief executive officer of Celsion said, This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm.

IASO Biotherapeutics Secures $108 Million Series C Funding to Advance Global Development of Innovative Cell Therapies

Thursday, September 16, 2021 - 1:00pm

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicines, today announced the completion of $108 million Series C to advance the global development of novel cell therapies and biologics for oncology and autoimmune diseases.

Key Points: 
  • IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicines, today announced the completion of $108 million Series C to advance the global development of novel cell therapies and biologics for oncology and autoimmune diseases.
  • Proceeds from the financing will be used to accelerate the global development and regulatory submissions of multiple novel cell therapies.
  • The clinical development of these three innovative products marks the full coverage of our products in plasma cell, B cell, and T cell malignancies.
  • IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases.

GeneQuantum announces two key leadership appointments

Thursday, September 16, 2021 - 2:00am

Their joining marks a concrete step forward in our strategic planning of establishing and expanding a world-class clinical and regulatory affairs team.

Key Points: 
  • Their joining marks a concrete step forward in our strategic planning of establishing and expanding a world-class clinical and regulatory affairs team.
  • Their extensive expertise and excellent leadership capability are crucial for the success of the company.
  • They commented, " GeneQuantum has the world's leading Antibody-Drug-Conjugate (ADC) iLDC platform, as well as a rich and innovative pipeline based on this platform.
  • We are very happy to join GeneQuantum in this critical moment, when the company is growing quickly with many products entering the IND and clinical stage.

Hua and Sinopharm Announced Supply Chain Strategic Cooperation

Wednesday, September 15, 2021 - 6:35am

SHANGHAI, CHINA, Sept 15, 2021 - (ACN Newswire) - On September 13, 2021, Hua Medicine (Shanghai) Ltd. (the "Hua Medicine", Stock Code: 2552.HK) has signed a supply chain strategic cooperation agreement with Sinopharm Group Co., Ltd. (the "Sinopharm", Stock Code: 1099).

Key Points: 
  • SHANGHAI, CHINA, Sept 15, 2021 - (ACN Newswire) - On September 13, 2021, Hua Medicine (Shanghai) Ltd. (the "Hua Medicine", Stock Code: 2552.HK) has signed a supply chain strategic cooperation agreement with Sinopharm Group Co., Ltd. (the "Sinopharm", Stock Code: 1099).
  • Hua Medicine will rely on Sinopharm's nation-wide drug distribution network to carry out in-depth cooperation in supply chain management.
  • "We are very glad to witness the strategic cooperation between Sinopharm and Hua Medicine, opening a new chapter on our cooperation.
  • In recent years, Sinopharm continue to innovate and build up the new ecosystem of the smart pharmaceutical and supply chain, improving the efficiency of supply chain.

Zai Lab Announces Breakthrough Therapy Designation Granted for Bemarituzumab (FPA144) in China

Tuesday, September 14, 2021 - 12:30pm

In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab.

Key Points: 
  • In granting Breakthrough Therapy Designation, we are pleased to see that the CDE recognizes the promise of bemarituzumab.
  • The Breakthrough Therapy Designation was granted based upon this subset of patients, based on IHC testing, showing at least 10% of tumor cells overexpressing FGFR2b.
  • Drugs that have been granted the Breakthrough Therapy Designation are prioritized by the CDE in communications, and in receiving guidance to promote the drug development progress.
  • Zai Lab has an exclusive license to develop and commercialize bemarituzumab in Greater China.

Legend Capital Led a New Round of Investment of Etana

Tuesday, September 14, 2021 - 12:42am

HONG KONG, Sept 14, 2021 - (ACN Newswire) - Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM).

Key Points: 
  • HONG KONG, Sept 14, 2021 - (ACN Newswire) - Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM).
  • Hong Tan, Managing Director of Legend Capital, said "We appreciate Etana's vision to provide Indonesia with cost-effective biopharmaceuticals.
  • Legend Capital is an independent professional venture capital company under Legend Holdings.
  • Its core business is positioned at the initial stage of venture capital and expansion stage growth investment.