X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
The partnership seeks to enhance the commercialization efforts of Ogivri (trastuzumab), an FDA-approved biosimilar product utilized in the treatment of patients diagnosed with breast cancer or metastatic stomach cancer.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Ogivri
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 10, 2024
Details:
Phesgo (pertuzumab and trastuzumab) is the HER2 humanized monoclonal antibody, which is indicated for the treatment of HER2-positive breast cancer and Advanced or recurrent HER2-positive colorectal cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Vorhyaluronidase Alfa
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2023
Details:
EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: EG12014
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2023
Details:
Keytruda (pembrolizumab), an anti-PD-1 therapy, is being developed in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma.
Lead Product(s): Pembrolizumab,Trastuzumab,Cisplatin
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Details:
ALX Oncology will use the proceeds to fund ongoing development of ALX148 (evorpacept), a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain, for hematologic and solid malignancies.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $63.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 10, 2023
Details:
ALX Oncology will use the proceeds to fund ongoing development of ALX148 (evorpacept), a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain, for hematologic and solid malignancies.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $55.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 05, 2023
Details:
ALX Oncology will use the proceeds to fund ongoing development of ALX148 (evorpacept), a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain, for hematologic and solid malignancies.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering October 04, 2023
Details:
ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in combination with trastuzumab in patients with HER2-positive gastric/gastroesophageal junction (“GEJ”) cancer.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2023
Details:
Phesgo (pertuzumab and trastuzumab) is the HER2 humanized monoclonal antibody, which is indicated for the treatment of HER2-positive breast cancer and Advanced or recurrent HER2-positive colorectal cancer.
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
Details:
EG12014, biosimilar of trastuzumab, is an anti-HER2 antibody-drug conjugate (ADC) which is being developed for HER2-positive unresectable locally advanced or metastatic breast cancer (MBC).
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: EG12014
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: EirGenix
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
The EC approved KEYTRUDA (pembrolizumab) anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric cancer.
Lead Product(s): Pembrolizumab,Trastuzumab,Cisplatin
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2023
Details:
Keytruda® (pembrolizumab), a humanized monoclonal anti-PD-1 therapy, receives positive opinion by CHMP recommending approval in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of GEJ adenocarcinoma.
Lead Product(s): Pembrolizumab,Trastuzumab,Cisplatin
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2023
Details:
ALX148 (evorpacept) is a next generation CD47 blocker, which is being investigated in patients with gastric cancer and gastroesophageal junction adenocarcinoma.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2023
Details:
Keytruda® (pembrolizumab) is a humanized monoclonal anti-PD-1 therapy that works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Lead Product(s): Pembrolizumab,Trastuzumab,Cisplatin
Therapeutic Area: Oncology Product Name: Keytruda
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2023
Details:
Nerlynx (neratinib) is a kinase inhibitor that irreversibly binds to EGFR, HER2, and HER4. It reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
Tukysa (tucatinib) is a TKI of HER2, inhibiting phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell proliferation, and showed antitumor activity in HER2 expressing tumor cells in combination with trastuzumab.
Lead Product(s): Tucatinib,Trastuzumab
Therapeutic Area: Oncology Product Name: Tukysa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
As a small molecule that can cross the blood brain barrier, Nerlynx (neratinib) potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option.
Lead Product(s): Neratinib,Capecitabine,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
With the closing of the deal, Biocon Biologics has full ownership of its collaboration assets, bTrastuzumab, bPegfilgrastim, bBevacizumab, bGlargine, bAspart, bPertuzumab and bGlargine 300U.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Ogivri
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biocon
Deal Size: $3,335.0 million Upfront Cash: $2,225.0 million
Deal Type: Acquisition November 29, 2022
Details:
Imlunestrant (LY3484356) is an investigational, oral selective estrogen receptor degrader (SERD) with pure antagonistic properties. The estrogen receptor (ER) is the key therapeutic target for patients with ER+/HER2- breast cancer.
Lead Product(s): Imlunestrant,Abemaciclib,Trastuzumab
Therapeutic Area: Oncology Product Name: LY3484356
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2022
Details:
Alligator out-licensed AC101 (HLX22) to the South Korean company AbClon, Inc. in 2016, who sub-licensed the drug candidate to Henlius Biotech for clinical and commercial development in China.
Lead Product(s): HLX22,Serplulimab,Trastuzumab
Therapeutic Area: Oncology Product Name: AC101
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2022
Details:
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Tuznue (trastuzumab) targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Tuznue
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2022
Details:
NDA for fixed-dose subcutaneous combination of RG6264 (pertuzumab) and trastuzumab (same monoclonal antibodies as in perjeta and herceptin), based on data including results from global phase III FeDeriCa study in patients with HER2-positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: HLX11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2022
Details:
In vivo (in living organisms), TUKYSA (tucatinib) inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.
Lead Product(s): Tucatinib,Trastuzumab,Oxaliplatin
Therapeutic Area: Oncology Product Name: Tuksya
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
Lead Product(s): Neratinib,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD.
Lead Product(s): DZD1516,Trastuzumab,Capecitabine
Therapeutic Area: Oncology Product Name: DZD1516
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2022
Details:
BI-1607 is a novel, fully human FcγRIIB-blocking antibody with a novel mechanism-of-action, designed to enhance FcγR-dependent antitumor immunity and has potential of increasing therapeutic activity of other Fc-dependent therapeutic antibodies.
Lead Product(s): BI-1607,Trastuzumab
Therapeutic Area: Oncology Product Name: BI-1607
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
Details:
Results at 8.4 years median follow-up showed benefit of combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (Perjeta-based regimen), versus Herceptin, chemotherapy and placebo, given as post-surgery IV treatment for people with lymph node-positive.
Lead Product(s): Pertuzumab,Trastuzumab,Carboplatin
Therapeutic Area: Oncology Product Name: Perjeta
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Frontier Science Foundation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
At a median duration of follow-up of 20.7 months, results of MOUNTAINEER trial showed a 38.1% cORR per blinded independent central review in HER2-positive patients who were assigned to receive Tuksya (tucatinib) in combination with trastuzumab.
Lead Product(s): Tucatinib,Trastuzumab,Oxaliplatin
Therapeutic Area: Oncology Product Name: Tuksya
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2022
Details:
In pre-clinical models of trastuzumab resistant MUC4 HER2+ breast cancer, treatment with INB03™ decreases MUC4 expression, reverses resistance to trastuzumab based therapies, and promotes an immunologically active TME.
Lead Product(s): INB03,Trastuzumab
Therapeutic Area: Oncology Product Name: INB03
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2022
Details:
The agreement includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy ® (ipilimumab, HLX13), Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).
Lead Product(s): Pertuzumab,Trastuzumab
Therapeutic Area: Oncology Product Name: HLX11
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Organon
Deal Size: $103.0 million Upfront Cash: $73.0 million
Deal Type: Licensing Agreement June 13, 2022
Details:
The results suggest that the combination of Nerlynx (neratinib), fulvestrant, and trastuzumab together is promising for treating HR+ and HER2-mutated MBC with prior exposure to CDK4/6i across a range of HER2 mutations.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
Efficacy results from the BTC cohort of 25 patients for Nerlynx (Neratinib) demonstrated an overall response rate (ORR) of 16%, 95% CI 4.5-36.1%), median progression free survival (PFS) of 2.8 months and overall survival (OS) of 5.4 months.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2022
Details:
NERLYNX (Neratinib) is prescription medicine used alone to treat adults with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and who have previously been treated with trastuzumab-based therapy.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Phesgo (pertuzumab) is the world's first fixed dose combination of two monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) in Oncology for the treatment of HER - 2 positive breast cancer.
Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase
Therapeutic Area: Oncology Product Name: Phesgo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2022
Details:
Reolysin (pelareorep) treatment resulted in a favorable Risk of Recurrence Score (ROR-S) in 100% of evaluable patients compared to 55% at baseline in a window-of-opportunity study.
Lead Product(s): Pelareorep,Atezolizumab,Trastuzumab
Therapeutic Area: Oncology Product Name: Reolysin
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: SOLTI-Innovative Cancer Research
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2022
Details:
Nerlynx (neratinib) is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors, or EGFRs, HER1, HER2 and HER4.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile for Troika (HD201), a biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 positive breast and metastatic gastric cancer.
Lead Product(s): Trastuzumab,Docetaxel,Epirubicin Hydrochloride
Therapeutic Area: Oncology Product Name: Troika
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
Details:
Evorpacept used in combination with ramucirumab, trastuzumab, and paclitaxel demonstrated an initial confirmed objective response rate of 72.2% with a median duration of response of 14.8 months, a 12-month overall survival rate of 79%.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
Phase 1/2a clinical trial, evaluate safety and preliminary efficacy of CYNK-101, genetically modified NK cell therapy in combination with standard chemotherapy, trastuzumab and pembrolizumab as a first-line treatment in advanced HER2/neu positive gastric and GEJ cancer.
Lead Product(s): CYNK-101,Trastuzumab,Pembrolizumab
Therapeutic Area: Oncology Product Name: CYNK-101
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents.
Lead Product(s): Evorpacept,Trastuzumab,Ramucirumab
Therapeutic Area: Oncology Product Name: ALX148
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2022
Details:
Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers. Sandoz is seeking approval for the same indications as the reference medicine.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: EGI014A1
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: EirGenix
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
Details:
Zenocutuzumab (MCLA-128) in combination with trastuzumab and vinorelbine in patients met primary endpoint of Clinical Benefit Rate at 24 weeks and showed clinically meaningful activity after 3 lines of anti-HER2 therapies including T-DM1.
Lead Product(s): Zenocutuzumab,Trastuzumab,Vinorelbine Tartrate
Therapeutic Area: Oncology Product Name: MCLA-128
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
Under this partnership, Prestige BioPharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.
Lead Product(s): Trastuzumab,Docetaxel
Therapeutic Area: Oncology Product Name: HD201
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 09, 2021
Details:
Five-year follow-up data reconfirm comparable long-term efficacy of ONTRUZANT ( trastuzumab-dttb), analysis with a larger group of patients with HER2-positive early or locally advanced breast cancer.
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Ontruzant
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2021
Details:
DESTINY-Breast11 phase 3 trial evaluating the efficacy and safety of ENHERTU®, a HER2 directed antibody drug conjugate (ADC) in patients with high-risk HER2 and the primary endpoint showed absence of invasive disease in the breast and lymph nodes assessed by BECR .
Lead Product(s): Deruxtecan,Paclitaxel,Trastuzumab
Therapeutic Area: Oncology Product Name: Enhertu
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Details:
The study investigated the efficacy and safety of Herceptin in combination with docetaxel. The primary endpoint was the response rate. 60% of 15 patients in the efficacy analysis population showed response (95%Cl: 32.3 - 83.7).
Lead Product(s): Trastuzumab
Therapeutic Area: Oncology Product Name: Herceptin
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2021
Details:
Pivotal HER2CLIMB trial showed that TUKYSA resulted in a robust and durable prolongation of overall survival that was consistent with results from the primary analysis for HER2-positive metastatic breast cancer patients with brain metastases.
Lead Product(s): Tucatinib,Capecitabine,Trastuzumab
Therapeutic Area: Oncology Product Name: Tukysa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Details:
NERLYNX approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer.
Lead Product(s): Neratinib,Fulvestrant,Trastuzumab
Therapeutic Area: Oncology Product Name: Nerlynx
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2021
Details:
Actinium evaluated the anti-HER2 antibody trastuzumab (Herceptin®) conjugated with either Actinium-225 (Ac-225) or Lutetium-177 (Lu-177) radioisotope payloads to explore potential synergies in combination with CD47 blocking antibodies.
Lead Product(s): Trastuzumab,Actinium-225,CD47 antibody
Therapeutic Area: Oncology Product Name: Herceptin
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
