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CPhI India 2024CPhI India 2024
Not Confirmed
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26-28 November, 2024
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11-14 November, 2024
TIDES Europe 2024TIDES Europe 2024
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12-14 November, 2024
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Events
Webinars & Exhibitions
CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
Industry Trade Show
Not Confirmed
11-14 November, 2024
TIDES Europe 2024TIDES Europe 2024
Industry Trade Show
Not Confirmed
12-14 November, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities
28 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/multiple-study-results-of-kelun-biotechs-trop2-adc-skb264-sac-tmt-at-2024-csco-congress-302261773.html
09 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/three-study-results-abstracts-from-kelun-biotechs-trop2-adc-skb264-sac-tmt-at-2024-esmo-released-today-302241655.html
20 Aug 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/kelun-biotechs-trop2-adc-skb264-sac-tmt-second-nda-accepted-by-npma-locally-advanced-or-metastatic-egfr-mutant-nsclc-302226239.html
20 Aug 2024
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/merck-bags-1-kelun-adc-375m-boots-out-another-asset-pipeline-tinkering-continues
24 Oct 2023
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/merck-discontinues-some-cancer-drug-development-with-chinas-sichuan-kelun-2023-10-23/
23 Dec 2022
// Ned Pagliarulo BIOPHARMADIVE
https://www.biopharmadive.com/news/merck-kelun-adc-antibody-drug-conjugate-cancer/639402/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32467
Submission : 2017-12-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32367
Submission : 2017-11-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40416
Submission : 2024-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-08
Pay. Date : 2023-03-28
DMF Number : 37986
Submission : 2023-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38463
Submission : 2023-06-02
Status : Active
Type : II
CEP/COS
Certificate Numbers : R0-CEP 2022-490 - Rev 00
Status : Valid
Issue Date : 2023-08-03
Type : Chemical
Substance Number : 2270
Details:
Merck has taken up its option on SKB571, a bispecific ADC that Kelun sees primarily as a treatment of solid tumors such as lung cancer and gastrointestinal tumors.
Lead Product(s): SKB571
Therapeutic Area: Oncology Brand Name: SKB571
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Merck & Co
Deal Size: $37.5 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 20, 2024
Lead Product(s) : SKB571
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : $37.5 million
Deal Type : Licensing Agreement
Merck & Co. Buys Kelun ADC For $37.5M, Drops Another Asset
Details : Merck has taken up its option on SKB571, a bispecific ADC that Kelun sees primarily as a treatment of solid tumors such as lung cancer and gastrointestinal tumors.
Brand Name : SKB571
Molecule Type : Large molecule
Upfront Cash : Undisclosed
August 20, 2024
Details:
A166 is an antibody-drug conjugate (ADC) composed of an anti-HER2 antibody conjugated to Duostatin-5, a novel anti-microtubule Auristatin derivative, via a proprietary stable covalent linker.
Lead Product(s): A166
Therapeutic Area: Oncology Brand Name: A166
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Levena Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Lead Product(s) : A166
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Levena Biopharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : A166 is an antibody-drug conjugate (ADC) composed of an anti-HER2 antibody conjugated to Duostatin-5, a novel anti-microtubule Auristatin derivative, via a proprietary stable covalent linker.
Brand Name : A166
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 01, 2022
Details:
The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing of upfront cash in exchange for ex-China rights to a “macromolecular tumor project".
Lead Product(s): Macromolecule-based Therapeutic
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Large molecule
Sponsor: Merck & Co
Deal Size: $1,407.0 million Upfront Cash: $47.0 million
Deal Type: Licensing Agreement May 16, 2022
Lead Product(s) : Macromolecule-based Therapeutic
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : $1,407.0 million
Deal Type : Licensing Agreement
China’s Kelun Pharma Jumps on Licensing New Cancer Drug to Holland’s Merck Sharp & Dohme
Details : The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing of upfront cash in exchange for ex-China rights to a “macromolecular tumor project".
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : $47.0 million
May 16, 2022
Details:
A166, a third-generation antibody-drug conjugate with tubulin inhibitor Duo-5 toxin, cleavable linker and site-specific K-Lock conjugation chemistry, demonstrated antitumor activity with meaningful responses in heavily pretreated subjects with HER2-positive breast cancer.
Lead Product(s): A166
Therapeutic Area: Oncology Brand Name: A166
Study Phase: Phase IIProduct Type: Large molecule
Recipient: Levena Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2022
Lead Product(s) : A166
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Levena Biopharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : A166, a third-generation antibody-drug conjugate with tubulin inhibitor Duo-5 toxin, cleavable linker and site-specific K-Lock conjugation chemistry, demonstrated antitumor activity with meaningful responses in heavily pretreated subjects with HER2-posit...
Brand Name : A166
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 03, 2022
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Sichuan Kelun Pharmaceutical is a supplier offers 5 products (APIs, Excipients or Intermediates).
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