Oncology | Phase II Developments | CHINA

AnHeart Therapeutics

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CHINA China

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First Patient Dosed with Taletrectinib in AnHeart Phase 2 Trial of Non-Small Cell Lung Cancer with ROS1 Fusion

Lead Product(s): Taletrectinib

Therapeutic Area: Oncology Product Name: AB-106

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 21, 2020

Details:

This Phase 2 trial will enroll approximately 106 NSCLC patients with ROS1 fusion and is designed as an open-label, single-arm, multi-center study in China.

AnHeart Therapeutics

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CHINA China

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AnHeart Therapeutics Announces License Agreement with NewG Lab for Taletrectinib Rights in Korea

Lead Product(s): Taletrectinib

Therapeutic Area: Oncology Product Name: AB-106

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: NewG Lab

Deal Size: $7.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement July 15, 2020

Details:

NewG Lab will be responsible for development, market authorization and commercialization activities for taletrectinib in Korea. AnHeart will allow NewG Lab to join its Phase 2 multi-regional clinical trial (MRCT) for non-small cell lung cancer (NSCLC) with ROS1/NTRK mutations.

AnHeart Therapeutics

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AnHeart Therapeutics Announces Acceptance of Taletrectinib Phase 1 Data for Publication in Clinical Cancer Research

Lead Product(s): Taletrectinib

Therapeutic Area: Oncology Product Name: AB-106

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2020

Details:

The lead clinical candidate taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier.

Ascentage Pharma

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CHINA China

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Ascentage Pharma Submits Its First New Drug Application to National Medical Products Administration, for HQP1351

Lead Product(s): HQP1351

Therapeutic Area: Oncology Product Name: HQP1351

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

Details:

Guangzhou Healthquest Pharma has submitted a NDA to the Center for Drug Evaluation of China National Medical Products Administration for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia and accelerated phase CML.

RemeGen

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CHINA China

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RemeGen Co., Ltd. Announced New RC48-ADC Data in Patients with Advanced Gastric Cancer at ASCO

Lead Product(s): Disitamab vedotin

Therapeutic Area: Oncology Product Name: RC48

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

Results demonstrated a clinically meaningful response and survival benefit for heavily treated patients with unmet need.

Alphamab Oncology

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China China

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Alphamab Oncology and Sanofi Enter Collaboration on KN026 in HER2+ Breast Cancer

Lead Product(s): KN026,Docetaxel

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Sanofi

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 09, 2020

Details:

According to the terms of the agreement, after reaching certain clinical milestones, Sanofi will have the right to negotiate the exclusive right to introduce KN026 during the exclusive period.

JW Therapeutics

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CHINA China

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JW Therapeutics, Today Announced the Completion of a US$100 Million Series B Round Financing

Lead Product(s): JWCAR029

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: CR-CP Life Science Fund

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing June 09, 2020

Details:

JW Therapeutics plans to use the proceeds to further advance its lead product JWCAR029 (a CAR-T cell product targeting CD19 in clinical phase II), further build-out a pipeline, and gear up to establish commercialization capabilities to support product launch.

Genor Biopharma

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CHINA China

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Hillhouse Leads $160M Round for Chinese Antibody Maker Genor

Lead Product(s): Genolimzumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Hillhouse

Deal Size: $160.0 million Upfront Cash: Undisclosed

Deal Type: Financing June 02, 2020

Details:

Genor will use proceeds of the Series B round to finance the clinical development of its existing pipeline, R&D of early-stage innovative drugs, potential strategic partnerships at home and abroad, as well as preparation for the commercialisation of its mature products.

I-Mab Biopharma

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I-Mab and Genexine Announce China NMPA Clearance for Phase 2 Clinical Trial of TJ107/HyLeukin-7™ in Glioblastoma Multiforme

Lead Product(s): Efineptakin alfa

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2020

Details:

China National Medical Products Administration (NMPA) has cleared the initiation of a Phase 2 clinical trial of TJ107/HyLeukin-7™ (Efineptakin alfa), in lymphopenic patients with newly-diagnosed glioblastoma multiforme (GBM).

Ascentage Pharma

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Ascentage Pharma's Core Drug Candidate HQP1351 Granted Orphan Drug Designation by the US FDA

Lead Product(s): HQP1351

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

HQP1351 is the first 3rd generation BCR-ABL inhibitor developed in China targeting drug-resistant CML. A pivotal Phase II study is currently under way to test HQP1351. Ascentage plans to file an NDA.

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Find Oncology Drugs in Phase II Clinical Development in CHINA

China

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Companies

AnHeart Therapeutics

First Patient Dosed with Taletrectinib in AnHeart Phase 2 Trial of Non-Small Cell Lung Cancer with ROS1 Fusion

AnHeart Therapeutics

AnHeart Therapeutics Announces License Agreement with NewG Lab for Taletrectinib Rights in Korea

AnHeart Therapeutics

AnHeart Therapeutics Announces Acceptance of Taletrectinib Phase 1 Data for Publication in Clinical Cancer Research

Ascentage Pharma

Ascentage Pharma Submits Its First New Drug Application to National Medical Products Administration, for HQP1351

RemeGen

RemeGen Co., Ltd. Announced New RC48-ADC Data in Patients with Advanced Gastric Cancer at ASCO

Alphamab Oncology

Alphamab Oncology and Sanofi Enter Collaboration on KN026 in HER2+ Breast Cancer

JW Therapeutics

JW Therapeutics, Today Announced the Completion of a US$100 Million Series B Round Financing

Genor Biopharma

Hillhouse Leads $160M Round for Chinese Antibody Maker Genor

I-Mab Biopharma

I-Mab and Genexine Announce China NMPA Clearance for Phase 2 Clinical Trial of TJ107/HyLeukin-7™ in Glioblastoma Multiforme

Ascentage Pharma

Ascentage Pharma's Core Drug Candidate HQP1351 Granted Orphan Drug Designation by the US FDA