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Digital content

28 Oct 2020
// PRNASIA
https://en.prnasia.com/releases/global/yiling-pharmaceutical-revenue-and-net-profit-attributable-to-the-parent-company-for-the-first-three-quarters-already-exceeded-the-full-year-2019-296445.shtml

07 Sep 2020
// BIOSPECTRUMASIA
https://www.biospectrumasia.com/news/25/16659/yiling-pharma-receives-first-international-approval-for-herbal-covid-19-medicine.html

03 Sep 2020
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/tcm-lianhua-qingwen-granted-first-international-approval-for-covid-19-treatment-301124374.html

28 Aug 2020
// PRNASIA
https://en.prnasia.com/releases/global/yiling-pharmaceutical-reports-52-75-yoy-growth-in-r-d-investment-boosting-the-company-s-high-quality-development-289659.shtml

13 Nov 2018
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206037

31 Oct 2018
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210847
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-02-19
Pay. Date : 2024-12-27
DMF Number : 40305
Submission : 2024-12-19
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-13
Pay. Date : 2024-10-31
DMF Number : 39423
Submission : 2024-09-29
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-03-11
Pay. Date : 2025-01-23
DMF Number : 40942
Submission : 2025-01-21
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20442
Submission : 2007-04-03
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19421
Submission : 2006-05-08
Status : Inactive
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20442
Submission : 2007-04-03
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-02-19
Pay. Date : 2024-12-27
DMF Number : 40305
Submission : 2024-12-19
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-01-13
Pay. Date : 2024-10-31
DMF Number : 39423
Submission : 2024-09-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-03-11
Pay. Date : 2025-01-23
DMF Number : 40942
Submission : 2025-01-21
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19421
Submission : 2006-05-08
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Details:
XY0206 is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.
Lead Product(s): XY0206
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2025

A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
Details : XY0206 is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 09, 2025

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Details:
14-C XY0206 is a Radiolabeled Compounds drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): 14-C XY0206
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Radiolabeled Compound
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2025

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Lead Product(s) : 14-C XY0206
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
Details : 14-C XY0206 is a Radiolabeled Compounds drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Radiolabeled Compound
Upfront Cash : Inapplicable
February 12, 2025

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Details:
XY03-EA is a drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Ischemic Stroke.
Lead Product(s): XY03-EA
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 01, 2025

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Lead Product(s) : XY03-EA
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
Details : XY03-EA is a drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Ischemic Stroke.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
January 01, 2025

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Details:
Bio-008 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Lead Product(s): Bio-008
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 07, 2023

A Study of Bio-008 in Subjects With Advanced or Metastatic Solid Tumours
Details : Bio-008 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
September 07, 2023

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Details:
XY0206 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Leukemia, Myeloid, Acute.
Lead Product(s): XY0206
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 25, 2023

Details : XY0206 is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Leukemia, Myeloid, Acute.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 25, 2023

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Details:
XY03-EA is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ischemic Stroke.
Lead Product(s): XY03-EA
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Undisclosed
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 25, 2022

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Lead Product(s) : XY03-EA
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : First Affiliated Hospital, Sun Yat-Sen University
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
Details : XY03-EA is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Ischemic Stroke.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
August 25, 2022

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Details:
Felbinac Trometamol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain.
Lead Product(s): Felbinac Trometamol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2022

A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China
Details : Felbinac Trometamol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 28, 2022

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Details:
Phenlarmide is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Parkinson Disease.
Lead Product(s): Phenlarmide
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Xuanwu Hospital, Beijing
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 05, 2021

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets
Details : Phenlarmide is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Parkinson Disease.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
January 05, 2021

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Details:
Felbinac Trometamol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain.
Lead Product(s): Felbinac Trometamol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 25, 2020

A Phase â…¢ Clinical Study Trial of Felbinac Trometamol Injection in China
Details : Felbinac Trometamol is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Pain.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 25, 2020

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Details:
XY0206 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.
Lead Product(s): XY0206
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Proswell Medical Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 14, 2020

A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia
Details : XY0206 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 14, 2020

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RLD : No
TE Code : AB
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
Dosage Form : TABLET; ORAL
Proprietary Name : ANASTROZOLE
Dosage Strength : 1MG
Approval Date : 2018-11-09
Application Number : 206037
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
Dosage Form : TABLET; ORAL
Proprietary Name : LETROZOLE
Dosage Strength : 2.5MG
Approval Date : 2018-11-14
Application Number : 205869
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
Dosage Form : TABLET; ORAL
Proprietary Name : ORVATEN
Dosage Strength : 2.5MG
Approval Date : 2004-11-03
Application Number : 76725
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
Dosage Form : TABLET; ORAL
Proprietary Name : ORVATEN
Dosage Strength : 5MG
Approval Date : 2004-11-03
Application Number : 76725
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
Dosage Form : TABLET; ORAL
Proprietary Name : ORVATEN
Dosage Strength : 10MG
Approval Date : 2004-11-03
Application Number : 76725
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

District Decision : Official Action Indicated
Inspection End Date : 2024-10-11
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
City : Shijiazhuang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Official Action Indicated
Inspection End Date : 2024-10-11

District Decision : No Action Indicated
Inspection End Date : 2022-04-15
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
City : Miyun
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2022-04-15

District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-15
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
City : Shijiazhuang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-15

District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-15
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
City : Miyun
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-15

District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-23
Shijiazhuang Yiling Pharmaceutical Co.,Ltd.
City : Shijiazhuang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-08-23

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Shijiazhuang Yiling Pharmaceutical Co.,Ltd. is a supplier offers 5 products (APIs, Excipients or Intermediates).
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