Weekly in Asia 2019｜AUG-3
20190818-0824 Weekly in Asia
CStone Gets Approval for Phase I trial of CDK4/6 Inhibitor CS3002 in Australia
CStone Pharmaceuticals, a leading China-based biopharmaceutical company, recently announced that it has received an ethics approval for the Phase I clinical trial of CS3002 from the Human Research Ethics Committee in Australia, and an electronic Clinical Trial Notification (eCTN) from Australia’s Therapeutic Goods Administration (TGA).
CS3002 is a selective inhibitor developed by CStone, which arrests cell cycle of tumor cells through the inhibition of the cyclin-dependent kinases 4 and 6 (CDK4/6). In addition to inducing cell cycle arrests, CDK4/6 inhibitors also strengthen anti-tumor immunity and modulate the tumor microenvironment. These characteristics of CS3002 provides the foundation for a new approach in cancer treatment, which is the combination of CDK4/6 inhibitors and immunotherapies in various solid tumors.
About Cstone Pharmaceuticals
Cstone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs. The company develops cancer therapeutics with a focus on immuno-oncology based combination therapies.
Propanc Biopharma Receives US Patent Covering Cancer Drug PRP Formulation
Propanc Biopharma Inc., a biopharmaceutical company based in Melbourne, announced on August 21th the receiving of a granted United States patent from the United States Patent and Trademark Office (USPTO).
Propanc’s lead product PRP is a long-term therapy based on a pancreatic proenzyme formulation. The granted patent confers exclusive rights to PRP, which includes trypsinogen and chymotrypsinogen, two digestive proenzymes that suppresses tumor recurrence and metastasis in the growth of several cancer cell lines. At Present, Propanc’s PRP has 65 patents either in force, or pending, in major global regions around the world, and has been planned to enter human trials in the near future.
About Propanc Biopharma
Propanc Biopharma, Inc. operates as a clinical stage biopharmaceutical company focused on developing new cancer treatments. The Company develops proenzyme therapy to treat and prevent recurrence and metastasis of pancreatic and colorectal cancer.
AstraZeneca’s Kidney Drug Roxadustat Receives Marketing Authorisation in China
Anemia is common in patients with chronic kidney disease (CKD) because the kidneys no longer produce adequate amounts of erythropoietin (EPO), a hormone involved in the production of red blood cells.
AstraZeneca announced on August 22nd that its partner FibroGen China Medical Technology Development Co., Ltd. has received marketing authorisation by China’s National Medical Products Administration (NMPA) for roxadustat in China for the treatment of anemia caused by CKD in non-dialysis-dependent (NDD) patients. Earlier in December 2018, the NMPA approved roxadustat for CKD-associated anemia in dialysis-dependent patients. AstraZeneca and FibroGen China expect to launch roxadustat in China during the second half of 2019. AstraZeneca will manage commercialisation activities, while FibroGen China manage commercial manufacturing and medical affairs as well as continued clinical development and regulatory affairs.
About FibroGen China
Based in Beijing, FibroGen China is a wholly-owned subsidiary of FibroGen Inc. that sponsored the development and registration of roxadustat.
AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in Oncology, Cardiovascular, Renal and Metabolism (CVRM) and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Innovent and Eli Lilly Signs Licensing Agreement to Develop and Commercialize Novel Diabetes Medicine In China
Diabetes is one of the world’s fastest-growing chronic diseases. The patients with diabetes in China is estimated to be 1 in 10 out of Chinese adult.
Innovent Biologics, Inc. announced on August 22nd that it has entered into a licensing agreement with Eli Lilly and Company for the development and potential commercialization in China of a new diabetes medicine, an oxyntomodulin analog known as OXM3. OXM3 is a dual glucagon-like peptide 1 (GLP-1) and glucagon receptor agonist derived from post-translational processing of preproglucagon in the gut that has been engineered to be a long-acting molecule, suitable for once-weekly injection. In early-stage clinical trials, OXM3 has demonstrated the effectiveness of weight loss and evidence of improved glycemic control under weekly administration. OXM3 has the potential to be developed as a therapy for diabetes, obesity and potentially nonalcoholic steatohepatitis (NASH).
About Eli Lilly and Company
Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products for humans and animals. Eli Lilly products include neuroscience, endocrine, anti-infectives, cardiovascular agents, oncology, and animal health products.
About Innovent Biologics, Inc.
Established in 2011, Innovent is a Chinese biopharmaceutical company committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of major diseases.
GSK Submits First Regulatory Application for Daprodustat in Japan for Patients With Renal Anemia Due to Chronic Kidney Disease
Anemia caused by chronic kidney disease (CKD) is associated with cardiovascular disease, hospitalization, cognitive impairment and reduced quality of life, and has been shown to increase the risk of death in patients with CKD. Anemia becomes increasingly common in patients with CKD as their disease progresses. It is estimated that, in Japan, around 3.5 million patients have anemia associated with renal disease.
GlaxoSmithKline PLC (GSK) announced on August 21st the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anemia due to CKD.
GSK’s filing is built upon data from two phase 3 trials, one compared to Amgen’s Aranesp in hemodialysis patients, another in CKD patients not on hemodialysis. Both trials found oral daprodustat is comparable of increasing levels of hemoglobin as Kirin‘s injectable incumbent drugs Espo and Nesp.
GlaxoSmithKline PLC operates as a research-based pharmaceutical company that develops, manufactures, and markets vaccines, prescription, and over-the-counter medicines, as well as health-related consumer products. GlaxoSmithKline provides products for infections, depression, skin conditions, asthma, heart and circulatory disease, and cancer.
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