CMS through its wholly-owned subsidiary signed a License Agreement with Cadila Healthcare Limited (“Zydus”) for its product Desidustat (ZYAN1) on 20 January 2020. According to the agreement, the Group through its wholly-owned subsidiary will gain a royalty bearing, exclusive, sub-licensable license under the licensed technology and Zydus data to develop, register and to manufacture, use and commercialise the in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan), and the manufacturing of the final product will be localized by the Group in China with technology transfer from Zydus. The term of the agreement starts on the date of signing the agreement until the last date of the occurrence of the following: (i) the expiration of the last–to-expire patent containing a valid claim covering the manufacture, use, import, offer for sale or sale of the product in the territory; (ii) ten years after the first commercial sale of the product in the territory; (iii) the expiration of all regulatory exclusivities for the product in the territory. Upon the expiration of the aforementioned term, the agreement may be renewable for every single period of five years thereafter as per certain conditions defined in the agreement.
Through this collaboration,
the Group’s product portfolio will be further
enriched and extended upon occurrence of the perspective commercialisation of
the Product in the Territory.
About
the Product
Desidustat（Phase
III clinical trial is ongoing oversea）
Desidustat is a novel oral
Hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) for treating
anemia in chronic kidney disease (CKD) patients. CKD is
involving gradual loss of functioning of kidneys and eventually lead to kidney
failure. If kidneys are healthy they will naturally secrete beneficial levels
of a hormone called erythropoietin (EPO), which encourages red blood cell
production. If the kidneys are impaired they will produce reduced levels or
tire of EPO production completely, leading to anemia. HIF-PHI promotes
erythropoiesis through increasing endogenous erythropoietin, improving iron
availability, and reducing hepcidin.
It
has been reported that more than 120 million people are estimated to be living
with CKD in China. Anemia is one of the frequent complications of CKD. A survey
in China showed that the prevalence of anemia in patients at CKD stage 1 to 5
were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively. The target-achieving
rate (the hemoglobin (Hb) level reaching the target value (110~120g / L)) was
only 8.2% for anemia patients in non-dialysis CKD and 35.2% for hemodialysis
CKD, showing large unmet healthcare need. Compared with the existing therapy,
Desidustat is administrated orally, thus expecting to improve the treatment
compliance of patients.
Zydus
had initiated two Phase III trials of Desidustat. The DREAM-ND
(ClinicalTrials.gov Identifier: NCT04012957) Phase III trial is being conducted
in CKD patients not-on-dialysis. The DREAM-D Phase III trial (ClinicalTrials.gov
Identifier: NCT04215120) is being conducted in CKD patients on dialysis. A
randomized, double-blind, placebo-controlled, parallel group, multicentric
phase 2 clinical trial had been conducted on 117 anemia patients in
non-dialysis CKD. After 6 weeks of treatment, as compared to placebo, in all
three Desidustat arms, the therapy showed statistically significant improvement
in the primary endpoint, change in Hb from baseline. In addition, the Hb
responder rates in secondary endpoint were over 60% in all three Desidustat
arms. In terms of safety, no serious adverse event was reported and there was
no significant change in vital signs, electrocardiographic parameters, or
safety laboratory values.
A
material patent has been granted in Mainland China, Hong
Kong Special Administrative Region, Macao Special Administrative Region and
Taiwan concerning Desidustat, which is a new molecular entity. The composition
of matter patent will expire in December 2033.
About Zydus
Zydus 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 nearly 25,000 people worldwide, including 1,400
scientists engaged in R & D, and is dedicated to creating healthier
communities globally.