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Luye Pharma Group Ltd (2186.HK)

2186.HK on Hong Kong Stock

5.70HKD
6 Dec 2019
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Latest Key Developments (Source: Significant Developments)

Luye Pharma Intends To Discuss With U.S. FDA On Further Development Of LY01005 In U.S
Thursday, 19 Sep 2019 

Sept 19 (Reuters) - Luye Pharma Group Ltd <2186.HK>::GROUP INTENDS TO DISCUSS WITH U.S. FOOD AND DRUG ADMINISTRATION ON FURTHER DEVELOPMENT OF LY01005 IN U.S.  Full Article

Luye Pharma's Transdermal Patch Receives German Medical Regulatory Approval
Monday, 15 Jul 2019 

July 15 (Reuters) - Luye Pharma Group Ltd <2186.HK>::GROUP'S RIVASTIGMINE ONCE A DAY TRANSDERMAL PATCH APPROVED BY GERMAN FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES.GROUP ALSO DEVELOPING PATENTED RIVASTIGMINE MULTI-DAY TRANSDERMAL PATCH (LY30410), OFFERING NEW DOSAGE REGIMEN.RIVASTIGMINE ONCE A DAY TRANSDERMAL PATCH IN DOSAGE STRENGTH 13.3MG/24H APPROVED BY GERMAN FEDERAL INSTITUTE FOR DRUGS &MEDICAL DEVICES.  Full Article

Luye Pharma's Rykindo NDA Filing Accepted By The U.S. FDA
Thursday, 30 May 2019 

May 30 (Reuters) - Luye Pharma Group Ltd <2186.HK>::LUYE PHARMA'S RYKINDO® NDA FILING ACCEPTED BY THE U.S. FDA.LUYE PHARMA GROUP -US FOOD AND DRUG ADMINISTRATION HAS COMPLETED THE FILING REVIEW AND ACCEPTED THE FILING OF RYKINDO'S NEW DRUG APPLICATION.  Full Article

Luye Pharma Group Says U.S. FDA Completed Filing Review For Rykindo
Wednesday, 29 May 2019 

May 29 (Reuters) - Luye Pharma Group Ltd <2186.HK>::U.S. FDA COMPLETED FILING REVIEW & HAS DETERMINED TO ACCEPT FILING OF A NEW DRUG APPLICATION FOR RYKINDO.  Full Article

Luye Pharma Group Announces Collaboration & License Deal With Pharmamar
Friday, 26 Apr 2019 

April 26 (Reuters) - Luye Pharma Group Ltd <2186.HK>::ANNOUNCES COLLABORATION AND LICENSE AGREEMENT WITH PHARMAMAR TO DEVELOP ONCOLOGY DRUG IN CHINA.UNDER DEAL CO WILL HAVE EXCLUSIVE RIGHTS TO DEVELOP AND COMMERCIALIZE ZEPSYRE FOR SMALL CELL LUNG CANCER IN CHINA.  Full Article

Luye Pharma Says Recombinant Anti-RANKL Human Monoclonal Antibody Injection Commenced Phase III Clinical Trial
Monday, 8 Apr 2019 

April 8 (Reuters) - Luye Pharma Group Ltd <2186.HK>::RECOMBINANT ANTI-RANKL HUMAN MONOCLONAL ANTIBODY INJECTION COMMENCED PHASE III CLINICAL TRIAL IN PEOPLE'S REPUBLIC OF CHINA.  Full Article

Luye Pharma Group Submits NDA To USFDA For Rykindo
Friday, 29 Mar 2019 

March 29 (Reuters) - Luye Pharma Group Ltd <2186.HK>::COMPANY SUCCESSFULLY SUBMITTED ITS FIRST NEW DRUG APPLICATION (NDA) TO U.S. FOOD AND DRUG ADMINISTRATION (''FDA'') FOR RYKINDO.  Full Article

Luye Pharma Reaches Strategic Partnership With Astrazeneca, Strengthens Commitment To Cardiovascular Therapeutic Field
Wednesday, 16 Jan 2019 

Jan 16 (Reuters) - Luye Pharma Group Ltd <2186.HK>::LUYE PHARMA REACHES STRATEGIC PARTNERSHIP WITH ASTRAZENECA, STRENGTHENS COMMITMENT TO CARDIOVASCULAR THERAPEUTIC FIELD.LUYE PHARMA GROUP LTD - GRANTS ASTRAZENECA EXCLUSIVES RIGHTS TO PROMOTE XUEZHIKANG CAPSULES IN MAINLAND CHINA.LUYE PHARMA - AGREEMENT WITH ASTRAZENECA CHINA GRANT ASTRAZENECA CHINA EXCLUSIVE RIGHTS TO PROMOTE CO'S XUEZHIKANG CAPSULES IN MAINLAND CHINA.LUYE PHARMA - CO, ASTRAZENECA CHINA ARE DISCUSSING POSSIBILITY OF EXPANDING XUEZHIKANG TO U.S. AND EUROPE.  Full Article

Luye Pharma Announces Clinical Trial Application Of Biological Antibody LY09004 Accepted By NMPA In China
Thursday, 3 Jan 2019 

Jan 3 (Reuters) - Luye Pharma Group Ltd <2186.HK>::ACCORDING TO SHANDONG BOAN BIOLOGICAL TECHNOLOGY CO, CLINICAL TRIAL APPLICATION OF BIOLOGICAL ANTIBODY LY09004 ACCEPTED BY NMPA IN CHINA.  Full Article

Luye Pharma Announces Approval From U.S. FDA For Clinical Trial For LY03010
Wednesday, 26 Sep 2018 

Sept 26 (Reuters) - Luye Pharma Group Ltd <2186.HK>::ANNOUNCES APPROVAL FROM U.S. FDA FOR CLINICAL TRIAL FOR LY03010.PALIPERIDONE PALMITATE INJECTABLE SUSPENSION OBTAINED APPROVAL FROM U.S FOOD AND DRUG ADMINISTRATION TO INITIATE CLINICAL TRIALS.  Full Article