Acacia Pharma Group plc | October 12, 2020
Acacia Pharma Group plc (“Acacia Pharma”, the “Group” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, announces that it has drawn down the remaining €10 million available under its unsecured €25 million loan facility with Cosmo Technologies Limited, a wholly-owned subsidiary of Cosmo Pharmaceuticals N.V. The Company plans to deploy this capital to support its ongoing US launches of BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting and BYFAVO™ (remimazolam for injection) for procedural sedation.
Innovent Biologics | September 02, 2021
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics (Shanghai) Inc., a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, today jointly announced that they have entered into an exclusive license agreement for the development and commercialization of GenFleet's lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.
GFH925, GenFleet's lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies.
According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China.
GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets.
About GFH925 (KRAS G12C Inhibitor)
Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest.
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products.
About GenFleet Therapeutics
Dedicated to serving significant unmet medical needs, GenFleet Therapeutics established its proprietary R&D platform based on the deep understanding of disease biology, translational medicine, as well as researches into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. GenFleet's rich and diversified pipeline highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 13 programs in development, four of which have entered clinical stages. GenFleet is expected progress additional programs into clinics, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.
PharmaJet | January 05, 2022
PharmaJet®, the maker of innovative, needle-free injection technology, announced that its partner Zydus Cadila, is partnering with Enzychem Lifesciences to manufacture their COVID-19 plasmid DNA vaccine in Korea. The plan is to manufacture 80+ million doses of the ZyCoV-D vaccine, which was recently granted emergency use approval by India’s national regulatory agency for those aged 12 years and above. The vaccine will be manufactured in Korea and exported to several lower-middle income countries in Latin America and Asian New Southern Policy member countries. It is exclusively delivered by the PharmaJet Tropis® Needle-free Injection System.
Under the terms of this agreement, Zydus will transfer its manufacturing technology and provide technical assistance to Enzychem Lifesciences. The vaccine is administered intradermally using the PharmaJet needle-free system, which can be deployed more readily, especially in resource-poor populations where these are urgently needed.
“This manufacturing agreement will enable people in lower-middle income countries access to a safe, well-tolerated and efficacious vaccine, delivered by a proven delivery system. Our systems have been successfully used to deliver millions of doses for polio immunization initiatives in Pakistan, Somalia, The Gambia, and numerous other countries. We are prepared for this commercialization initiative and have scaled our operations to meet the demand driven by COVID-19 vaccinations as we continue to fulfill our company mission of improving peoples’ lives through our needle-free delivery technology.”
Chris Cappello, President and CEO of PharmaJet
PharmaJet’s mission is to improve people’s lives through needle-free technology. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections.
Headquartered in Seoul, South Korea, Enzychem Lifesciences is developing novel small molecule therapeutics to target fundamental pathways in inflammation, patients with significant unmet needs in oncology, inflammatory, and severe respiratory diseases. Enzychem lead candidate, EC-18, has successfully completed US FDA phase 2 clinical testing in cancer patients. In response to the Korean government pledge for a Vaccine Hub, Enzychem has formed a consortium with Hanmi Pharma and several domestic companies in Korea to manufacture vaccines against COVID 19. The company plans to leverage its expertise in lipid chemistry and manufacturing to establish itself as a regional producer of lipid-based formulations for improved delivery of nucleic acids and other biologicals and drugs.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 23,000 people worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating healthier communities globally.