Oncology | Phase II Developments | CHINA

I-Mab Biopharma

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FCE Pharma

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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

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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FCE 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

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.

RemeGen

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FCE Pharma

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RemeGen Announces US FDA Clearance of IND Application to Initiate Phase II Clinical Trial in Urothelial Cancer

Lead Product(s): Disitamab vedotin

Therapeutic Area: Oncology

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 April 29, 2020

Details:

The IND clearance for RC48's first US-based trial arrives on the heels of RemeGen's recently completed $100 million plus financing, led by Lilly Asia Ventures and Lake Bleu Capital.

Innovent Biologics

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FCE Pharma

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Innovent Announces First Patient Dosed in a Pivotal Trial of Parsaclisib in Patients with Indolent Lymphoma in China

Lead Product(s): Parsaclisib

Therapeutic Area: Oncology

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 April 27, 2020

Details:

Company achieved first patient dosing in a pivotal Phase 2 registrational trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor, in China.

Alphamab Oncology

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FCE Pharma

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Alphamab Oncology Received U.S. FDA IND Approval to Initiate A Phase II Clinical Trial of KN046 For NSCLC in the United States

Lead Product(s): KN046

Therapeutic Area: Oncology

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 April 16, 2020

Details:

KN046's Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.

Shanghai Junshi Biosciences

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FCE Pharma

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Junshi Biosciences Receives Orphan Drug Designation from FDA for Toripalimab-Axitinib Combo

Lead Product(s): Toripalimab,Axitinib

Therapeutic Area: Oncology

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 March 30, 2020

Details:

U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma.

InnoCare Pharma

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FCE Pharma

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Chinese cancer drugs developer InnoCare raises US$289 million after Hong Kong IPO is nearly 300 times oversubscribed

Lead Product(s): Orelabrutinib

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $289.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 20, 2020

Details:

Half of the listing proceeds will be used to fund the development of orelabrutinib in China and the US and the rest for developing other drugs.

Tyligand Bioscience

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FCE Pharma

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Tyligand Bioscience and Context Therapeutics Sign Development Agreement

Lead Product(s): Onapristone

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Context Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 12, 2020

Details:

Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs.

HUYA Bioscience International

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HUYA Bioscience International Appoints Meiji Seika Pharma as Exclusive Distributor For HBI-8000 in Japan and Other Asian Countries

Lead Product(s): Tucidinostat

Therapeutic Area: Oncology

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Meiji Seika Pharma Co Ltd.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration January 08, 2020

Details:

HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights.

I-Mab Biopharma

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I-Mab Biopharma Announces Dosing of First Patient in a Pivotal Phase 2 Study of TJ202/MOR202 in Multiple Myeloma in Mainland China

Lead Product(s): MOR202,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology

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 January 03, 2020

Details:

I-Mab initiated two registrational trials with TJ202/MOR202 in relapsed or refractory MM in Taiwan in early 2019 &expanded these trials into mainland China in late 2019, after receiving IND clearance from the (NMPA)

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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

RemeGen

RemeGen Announces US FDA Clearance of IND Application to Initiate Phase II Clinical Trial in Urothelial Cancer

Innovent Biologics

Innovent Announces First Patient Dosed in a Pivotal Trial of Parsaclisib in Patients with Indolent Lymphoma in China

Alphamab Oncology

Alphamab Oncology Received U.S. FDA IND Approval to Initiate A Phase II Clinical Trial of KN046 For NSCLC in the United States

Shanghai Junshi Biosciences

Junshi Biosciences Receives Orphan Drug Designation from FDA for Toripalimab-Axitinib Combo

InnoCare Pharma

Chinese cancer drugs developer InnoCare raises US$289 million after Hong Kong IPO is nearly 300 times oversubscribed

Tyligand Bioscience

Tyligand Bioscience and Context Therapeutics Sign Development Agreement

HUYA Bioscience International

HUYA Bioscience International Appoints Meiji Seika Pharma as Exclusive Distributor For HBI-8000 in Japan and Other Asian Countries

I-Mab Biopharma

I-Mab Biopharma Announces Dosing of First Patient in a Pivotal Phase 2 Study of TJ202/MOR202 in Multiple Myeloma in Mainland China