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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Regulatory

Regulatory  ·  Weekly Digest - 12 September to 18 September 2026
SYS6010 received NMPA BTD in China for actionable genomic alteration-negative non-squamous NSCLC

Weekly Digest – September 2026 Weekly Digest – September 2026 15 September 2026: SYS6010 received NMPA BTD in China for actionable genomic alteration-negative non-squamous NSCLC CSPC Pharmaceutical Group announced that SYS6010 has received BTD from China’s NMPA for recurrent or […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 12 September to 18 September 2026
Hengrui’s HER3 ADC, SHR-A2009 for injection, included in China’s Breakthrough Therapy list for NSCLC

Weekly Digest – September 2026 Weekly Digest – September 2026 14 September 2026: Hengrui’s HER3 ADC, SHR-A2009 for injection, included in China’s Breakthrough Therapy list for NSCLC Hengrui Medicine announced that its HER3-directed ADC SHR-A2009 has been included in China’s […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 12 September to 18 September 2026
Sino Biopharmaceutical announces NDA acceptance for TQB2102 in HER2-low Breast cancer in China

Weekly Digest – September 2026 Weekly Digest – September 2026 16 September 2026: Sino Biopharmaceutical announces NDA acceptance for TQB2102 in HER2-low Breast cancer in China Sino Biopharmaceutical has received China CDE acceptance of the NDA for TQB2102 in adults […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 05 September to 11 September 2026
Adlai Nortye announced the first patient dosing in Australia and U.S. FDA IND clearance for AN4035

Weekly Digest – September 2026 Weekly Digest – September 2026 08 September 2026: Adlai Nortye announced the first patient dosing in Australia and U.S. FDA IND clearance for AN4035 Adlai Nortye announced that the first patient has been dosed in […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 05 September to 11 September 2026
InnoCare announced approval in China to initiate clinical trials of ICP-B381, a novel PSMA/STEAP1-targeting bispecific ADC

Weekly Digest – September 2026 Weekly Digest – September 2026 09 September 2026: InnoCare announced approval in China to initiate clinical trials of ICP-B381, a novel PSMA/STEAP1-targeting bispecific ADC InnoCare Pharma announced that China’s NMPA has approved the clinical trial […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 29 August to 04 September 2026
Hansoh Pharmaceutical’s HS-20093 injection marketing authorization application for SCLC accepted by China’s NMPA

Weekly Digest – September 2026 Weekly Digest – September 2026 02 September 2026: Hansoh Pharmaceutical’s HS-20093 injection marketing authorization application for SCLC accepted by China’s NMPA Hansoh Pharma announced that the NMPA has formally accepted the marketing authorization application for […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 29 August to 04 September 2026
IDEAYA Biosciences’ IDE849 advances to a phase 3 registrational trial following a successful FDA type C meeting for ES-SCLC

Weekly Digest – September 2026 Weekly Digest – September 2026 31 August 2026: IDEAYA Biosciences’ IDE849 advances to a phase 3 registrational trial following a successful FDA type C meeting for ES-SCLC IDEAYA Biosciences announced a successful FDA Type C […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 22 August to 28 August 2026
DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC

Weekly Digest – August 2026 Weekly Digest – August 2026 25 August 2026: DualityBio’s DB-1317 granted FDA Fast Track Designation for advanced PDAC DualityBio announced that its ADAM9-targeted ADC candidate DB-1317 has been granted Fast Track Designation by the U.S. […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 22 August to 28 August 2026
SOTIO’s SOT106 granted FDA Fast Track Designation for Soft Tissue Sarcoma

Weekly Digest – August 2026 Weekly Digest – August 2026 26 August 2026: SOTIO’s SOT106 granted FDA Fast Track Designation for Soft Tissue Sarcoma SOTIO announced that the U.S. FDA has granted Fast Track Designation to SOT106, an LRRC15-targeted ADC, […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 15 August to 21 August 2026
Akeso’s AK157D1 cleared for phase 1 trial in Solid tumors

Weekly Digest – August 2026 Weekly Digest – August 2026 21 August 2026: Akeso’s AK157D1 cleared for phase 1 trial in Solid tumors Akeso announced that its B7-H3-targeted ADC candidate AK157D1 has been cleared by China’s NMPA Center for Drug […]

by Sandhya Ramalingam

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