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23-26 March, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
Digital content

04 Dec 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/after-dodging-biosecure-threat-wuxi-apptec-pentagons-crosshairs

20 Nov 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/wuxi-apptec-receives-frost--sullivans-2025-global-company-of-the-year-award-in-the-crdmo-industry-302620253.html

28 Oct 2025
// FIERCE BIOTECH
https://www.fiercebiotech.com/cro/wuxi-apptec-sharpens-focus-selling-clinical-research-units

21 Sep 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/wuxi-apptec-implements-its-first-interim-dividend-plan-distributing-rmb1-03-billion-in-cash-dividends-302562337.html

08 Sep 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/wuxi-apptec-awarded-gold-medal-by-ecovadis-sustainability-rating-for-second-consecutive-year-302547481.html

27 Aug 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/wuxi-apptec-completes-second-rmb1-0-billion-a-share-repurchase-program-in-2025--all-repurchased-shares-to-be-cancelled-302540052.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37610
Submission : 2023-06-07
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 : 36725
Submission : 2022-02-03
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 : 36104
Submission : 2021-07-22
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-24
Pay. Date : 2021-04-14
DMF Number : 34821
Submission : 2020-05-29
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 : 38725
Submission : 2023-08-16
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 : 40431
Submission : 2024-08-29
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 : 32693
Submission : 2019-01-02
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 : 33124
Submission : 2018-12-28
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 : 37861
Submission : 2022-12-28
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 : 37862
Submission : 2022-12-28
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37610
Submission : 2023-06-07
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36725
Submission : 2022-02-03
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36104
Submission : 2021-07-22
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40392
Submission : 2024-09-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40389
Submission : 2024-09-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40390
Submission : 2024-09-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40391
Submission : 2024-09-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40395
Submission : 2024-10-10
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40393
Submission : 2024-10-10
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40396
Submission : 2024-10-10
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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Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2022-11-30
Registration Number : Su171-4-ND
Manufacturer Name : Shanghai SynTheAll Pharmaceuti...
Manufacturer Address : No. 9 Yuegong Rd., Jinshan Subbranch(West), Chemistry Industry Zone, Shanghai, 201507...

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Registrant Name : Easy Biopharm Co., Ltd.
Registration Date : 2023-03-10
Registration Number : Su171-4-ND(1)
Manufacturer Name : Shanghai SynTheAll Pharmaceuti...
Manufacturer Address : No. 9 Yuegong Rd., Jinshan Subbranch(West), Chemistry Industry Zone, Shanghai, 201507...

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Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2021-07-09
Registration Number : Su248-16-ND
Manufacturer Name : Shanghai SyntheAll Pharmaceuti...
Manufacturer Address : No.9, Yuegong Road, Jinshan District, Shanghai, 201507, China

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Registrant Name : Biwon Medison Korea Co., Ltd.
Registration Date : 2022-09-16
Registration Number : Su969-1-ND
Manufacturer Name : Changzhou SynTheAll Pharmaceut...
Manufacturer Address : 589 North Yulong Road, Xinbei District Changzhou, Jiangsu, 213127, China

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 24538-445
Start Marketing Date : 2019-10-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-770
Start Marketing Date : 2014-07-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-208
Start Marketing Date : 2018-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-021
Start Marketing Date : 2023-02-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-606
Start Marketing Date : 2017-05-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-661
Start Marketing Date : 2018-02-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 24538-599
Start Marketing Date : 2025-04-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PR...

NDC Package Code : 24538-311
Start Marketing Date : 2019-11-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Details:
Nano-Mupirocin, an antibiotic targeting bacterial isoleucyl-tRNA synthetase, shows promise in treating Methicillin-Resistant Staphylococcus aureus (MRSA).
Lead Product(s): Nano-Mupirocin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Antibiotic
Recipient: Revium Rx
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2025

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Lead Product(s) : Nano-Mupirocin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Recipient : Revium Rx
Deal Size : Inapplicable
Deal Type : Inapplicable
Revium Rx Progresses to Phase 1 for Nano-Mupirocin Against Antibiotic-Resistant Infections
Details : Nano-Mupirocin, an antibiotic targeting bacterial isoleucyl-tRNA synthetase, shows promise in treating Methicillin-Resistant Staphylococcus aureus (MRSA).
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 21, 2025

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Through the partnership, Silo Pharma will advance the development of the SPU-16 for an early-stage study, a central nervous system homing peptide targeting multiple sclerosis.
Lead Product(s): SPU-16,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Peptide, Unconjugated
Sponsor: Silo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 07, 2024

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Lead Product(s) : SPU-16,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Silo Pharma
Deal Size : Undisclosed
Deal Type : Partnership
Silo Pharma Announces Partnership with Global CRO for CNS Homing Peptide
Details : Through the partnership, Silo Pharma will advance the development of the SPU-16 for an early-stage study, a central nervous system homing peptide targeting multiple sclerosis.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
August 07, 2024

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Details:
Under the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201, a 4-1BB-containing fully human CD19-CAR T, in systemic lupus erythematosus and idiopathic inflammatory myopathies, or myositis.
Lead Product(s): Resecabtagene Autoleucel,Inapplicable
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Cell & Gene Therapy
Sponsor: Cabaletta Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 22, 2023

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Lead Product(s) : Resecabtagene Autoleucel,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Cabaletta Bio
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the agreement, WuXi ATU will serve as a cell processing manufacturing partner for the planned global clinical development of CABA-201, a 4-1BB-containing fully human CD19-CAR T, in systemic lupus erythematosus and idiopathic inflammatory myopathies...
Product Name : Undisclosed
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
August 22, 2023

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Details:
Through the partnership, Interius will leverage WuXi ATU's CTDMO platform for Good Manufacturing Process (GMP) manufacturing of Phase I clinical product and will advance INT-2104 in vivo CART program for B cell malignancies to the clinic.
Lead Product(s): INT2104,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Cell & Gene Therapy
Sponsor: Interius BioTherapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 08, 2023

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Lead Product(s) : INT2104,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Interius BioTherapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Details : Through the partnership, Interius will leverage WuXi ATU's CTDMO platform for Good Manufacturing Process (GMP) manufacturing of Phase I clinical product and will advance INT-2104 in vivo CART program for B cell malignancies to the clinic.
Product Name : Undisclosed
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
May 08, 2023

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Details:
PAS-004 (CIP-137401) is a small molecule allosteric inhibitor of MEK 1/2 in the Ras-Raf-MEK-ERK signaling pathway, which plays critical roles in the regulation of diverse cellular activities, including cell proliferation, survival, differentiation, and motility.
Lead Product(s): PAS-004,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Miscellaneous
Recipient: Pasithea Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 18, 2023

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Lead Product(s) : PAS-004,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : IND Enabling
Recipient : Pasithea Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Details : PAS-004 (CIP-137401) is a small molecule allosteric inhibitor of MEK 1/2 in the Ras-Raf-MEK-ERK signaling pathway, which plays critical roles in the regulation of diverse cellular activities, including cell proliferation, survival, differentiation, and m...
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 18, 2023

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Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral (AAV) vectors than traditional AAV manufacturing systems.
Lead Product(s): Undisclosed,Inapplicable
Therapeutic Area: Technology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Sponsor: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 11, 2022

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Lead Product(s) : Undisclosed,Inapplicable
Therapeutic Area : Technology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine
Deal Size : Undisclosed
Deal Type : Licensing Agreement
WuXi ATU Announces Licensing Agreement with Janssen for TESSA™ Technology
Details : Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral (AAV) vectors than traditional AAV manufacturing systems.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
August 11, 2022

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TFC-1326 has the potential to replace or supplement dermal filler injections to treat the static wrinkles. TFC-1326 with its unique mechanism of action is revolutionary in the aesthetic skin care space.
Lead Product(s): TFC-1326,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Miscellaneous
Sponsor: Sirona Biochem Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 22, 2022

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Lead Product(s) : TFC-1326,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Sirona Biochem Corp
Deal Size : Undisclosed
Deal Type : Agreement
Details : TFC-1326 has the potential to replace or supplement dermal filler injections to treat the static wrinkles. TFC-1326 with its unique mechanism of action is revolutionary in the aesthetic skin care space.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
June 22, 2022

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The partnership initially focusses on Chimeric’s two autologous CAR T-cell therapies for solid tumours: CHM 2101, currently in late preclinical for gastrointestinal cancers and CHM 1101 (CLTX CAR T), currently in single-site phase 1 for recurrent or progressive glioblastoma.
Lead Product(s): CHM 1101,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Cell & Gene Therapy
Recipient: Chimeric Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 12, 2022

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Lead Product(s) : CHM 1101,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase I
Recipient : Chimeric Therapeutics
Deal Size : Undisclosed
Deal Type : Partnership
Chimeric Enters Strategic Manufacturing Partnership With WuXi Advanced Therapies
Details : The partnership initially focusses on Chimeric’s two autologous CAR T-cell therapies for solid tumours: CHM 2101, currently in late preclinical for gastrointestinal cancers and CHM 1101 (CLTX CAR T), currently in single-site phase 1 for recurrent or pr...
Product Name : Undisclosed
Product Type : Cell & Gene Therapy
Upfront Cash : Undisclosed
April 12, 2022

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Details:
Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid time frame.
Lead Product(s): Undisclosed,Inapplicable
Therapeutic Area: Technology Brand Name: Undisclosed
Study Phase: Discovery PlatformProduct Type: Undisclosed
Sponsor: Orbit Discovery
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 07, 2022

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Lead Product(s) : Undisclosed,Inapplicable
Therapeutic Area : Technology
Highest Development Status : Discovery Platform
Partner/Sponsor/Collaborator : Orbit Discovery
Deal Size : Undisclosed
Deal Type : Partnership
Details : Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid time frame.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
March 07, 2022

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The National Drug Administration of China (NMPA) Drug Evaluation Center (CDE) has prioritized the new drug application (NDA) for Orelabrutinib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL).
Lead Product(s): Orelabrutinib,Inapplicable
Therapeutic Area: Neurology Brand Name: Hibruka
Study Phase: Phase IIProduct Type: Miscellaneous
Recipient: InnoCare Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 13, 2021

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Lead Product(s) : Orelabrutinib,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Recipient : InnoCare Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
InnoCare Orelabrutinib Included in Priority Review by NMPA
Details : The National Drug Administration of China (NMPA) Drug Evaluation Center (CDE) has prioritized the new drug application (NDA) for Orelabrutinib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic l...
Product Name : Hibruka
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 13, 2021

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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WuXi AppTec is a supplier offers 27 products (APIs, Excipients or Intermediates).
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