Yangtze River Pharmaceutical, TraceLink | May 06, 2021
TraceLink Inc., the leading digital network platform company, today announced that Yangtze River Pharmaceutical Group has selected TraceLink's global compliance solution to aid its plans for global growth. As the company gears up for international market expansion this year, Yangtze River Pharmaceutical Group (YRPG) will use TraceLink's multienterprise compliance applications and industry-leading digital supply network to comply with track and trace requirements in multiple markets, including the United States and Europe.
"As we approach our 50th anniversary this year, we are preparing to deliver our innovations to global markets beyond China," said Mr. Luo Bai Gui GM's Executive Assistant, International Projects from YRPG. "Given the broad scope of our portfolio and diverse business model, TraceLink' s integrated network, global compliance solutions and low total cost of ownership are crucial for us to achieve commercial success in multiple markets."
"Global commercialization has become a top priority during this special milestone year for YRPG and serialization compliance is a necessary step in their preparation for global expansion," said Shabbir Dahod, President and CEO, TraceLink. "As one of the top pharmaceutical enterprises in China, YRPG is highly esteemed for its relentless innovation and TraceLink is proud to be their serialization partner of record as they embark on their journey of continued global growth."
With more than 16,000 employees and over 20 subsidiaries located across China, YRPG has established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCMs) and biological medicines. Yangtze River Pharmaceutical Group's products include Chinese, Western medicines and APIs, covering ten fields, nearly 20 dosage forms and over 300 types of medicines and strengths. Nearly 100 innovative drugs for major diseases are currently under research & development.
About Yangtze River Pharmaceutical Group
With a total manufacturing footprint of more than 3 million square meters, Yangtze River Pharmaceutical Group employs 16,000 and owns 11 manufacturing subsidiaries located in Beijing, Shanghai, Nanjing, Guangzhou, etc. The company fields established R&D and production bases for innovative chemical medicines, patent traditional Chinese Medicine (TCM) and biological medicines. Currently, Yangtze River Pharmaceutical Group exports part of its portfolio assortment to 30 countries including Europe, Asia and Africa.
TraceLink is the only business network creation platform for building integrated business ecosystems with multienterprise applications. Business networks are the foundation of an Industry 4.0 digitalization strategy that delivers customer-centric agility and resiliency of the end-to-end supply network leveraging the collective intelligence of an industry. TraceLink's Opus Digital Network Platform enables speed of open innovation and implementation with a partner ecosystem for no-code and low-code development of solutions and applications.
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.
Kedalion Therapeutics, | November 16, 2021
Kedalion Therapeutics is pleased to announce the completion of its Series B financing led by Novartis and involving a combination of new and existing investors. The Novartis investment includes an Exclusive Option to Acquire the company and its AcuStream™ technology. This agreement follows a Feasibility Study agreement with the AcuStream™ technology signed earlier this year. The subsequent feasibility study has been completed with successful results. Collaboration between the two parties is ongoing. The financial and other terms of this transaction are not disclosed.
Kedalion’s AcuStream™ platform is a highly innovative, digitally connected, electromechanical topical ocular delivery device that aims to address a potential unmet need for a convenient, user-friendly device that reliably, accurately, and comfortably delivers topical ocular therapy with improved efficiency and patient comfort, and reduced reliance on patient skill and instillation technique when administered by a physician.1 The multi-dose, preservative-free platform strives to enable intended aim, potential for a comfortable patient experience, micro-dosing capability, and in phase 1 proof of concept studies, has shown a potential for a reduction in delivery dose of an intended therapy.1-4 Kedalion will continue to move forward with the development of the AcuStream™ platform across multiple disease categories, drug classes and compositions, including the treatment of presbyopia. The AcuStream™ technology has a potential to enhance the patient experience and optimize treatment outcomes of the company’s highly advanced portfolio of topical ocular drug products in development.
The company looks forward to the opportunity to collaborate with Novartis Innovative Medicines as a valued investor and partner in developing our technology platform and therapeutic targets.
“At Novartis, we are committed to reimagining medicine and investigating innovative approaches that have the potential to address unmet patient needs. The AcuStream™ technology is a novel platform with broad applicability in ophthalmics and we envisio that it could help us deliver transformative solutions to the patients who rely on our therapeutics to treat a range of eye conditions.”
Jill Hopkins, Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals
Dr. Mark Blumenkranz, the Chairman and Chief Executive of Kedalion Therapeutics, commented that “this transaction and associated further studies will help us accomplish our goal of revolutionizing the way drugs are delivered to the eye. The AcuStream™ technology, which strives to enable easier aiming, micro-dosing capability, and a potential for a reduction in delivery dose of an intended therapy, has the potential for a comfortable patient experience for patients worldwide.1 The platform could potentially provide convenience and enable micro-dosing capability for various ocular diseases.1 We see our capabilities coupled with the scientific and market leadership of Novartis in ophthalmics to be a winning formula for both organizations.”
About Kedalion Therapeutics
Kedalion Therapeutics is a venture-backed, clinical-stage biotechnology company whose mission is to bring to market transformative topical ophthalmic therapies for new and existing indications. Kedalion’s proprietary AcuStream™ platform technology delivers topical drugs to the eye in a precise and accurate manner that enables comparable effect with up to an 80% reduction in dose compared to standard eye drops. Kedalion is based in Menlo Park, CA.