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Details:
Maiweijian (denosumab) is a fully human recombinant anti-RANKL monoclonal antibody, which is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: Maiweijian
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Details:
Wyost (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is approved for patients with bone metastases from solid tumors.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: Wyost
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2024
Details:
Xgeva (denosumab) is a human monoclonal antibody and a RANK ligand inhibitor. Its new formulation is indicated for the treatment of patients with bone metastases.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: Xgeva
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2024
Details:
MW032 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia. It is a RANK ligand inhibitor, which is being evaluated for treament of bone metastases from solid tumors.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: MW032
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 February 21, 2024
Details:
AVT03 (denosumab) is a human monoclonal antibody and a biosimilar candidate to Prolia & Xgeva. It is a RANK ligand inhibitor, which is being evaluated in phase 1 trials for bone loss in adult men.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: AVT03
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2024
Details:
Under the terms of agreement, mAbxience will fully develop the biosimilar, Denosumab (ref Prolia and XGEVA) and manufacture in it's GMP-approved facilities, while Amneal will guide the product through regulatory approval and have exclusive commercialization rights in the US.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: MB-09
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amneal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 12, 2023
Details:
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: GP2411
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 May 25, 2023
Details:
Mailishu (denosumab) is a human monoclonal antibody designed to bind and inhibit RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: Mailishu
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
Details:
Denosumab is a human monoclonal antibody designed to bind and inhibit RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss, and subsequently the likelihood of fractures and other serious bone conditions.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
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 February 06, 2023
Details:
Denosumab (GP2411) is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts. By binding to and inhibiting RANKL, denosumab decreases the production and activity of osteoclasts, resulting in a reduction of bone loss.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: GP2411
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 19, 2022
Details:
The biosimilars planned under this agreement include biosimilar of Prolia® (denosumab, AVT03), Xgeva® (denosumab), Simponi® (golimumab), and Eylea® (aflibercept) as well as two undisclosed proposed biosimilars for immunology and oncology.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: AVT03
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: DKSH
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 07, 2022
Details:
AVT03 is human mAB and biosimilar candidate to Prolia® and Xgeva® (denosumab), targets and binds with high affinity and specificity to RANK ligand membrane protein, preventing RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: AVT03
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 August 25, 2022
Details:
AVT03 (denosumab), is human mAB that targets high affinity and specificity to RANK ligand membrane protein, preventing RANK ligand from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: AVT03
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 20, 2022
Details:
According to the agreement, Richter is responsible for the development of the denosumab, Products (to conduct both Phase 1 and Phase 3 global clinical studies) and will supply finished commercial Products for the US market.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 09, 2021
Details:
A second arm of the trial, evaluating RXC004 in combination with the anti-PD-1 antibody nivolumab in patients with MSS mCRC, is expected to commence in the first half of 2022 once a recommended dose has been established in the ongoing Phase 1 dose escalation combination trial.
Lead Product(s): RXC004,Denosumab
Therapeutic Area: Oncology Product Name: RXC004
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 15, 2021
Details:
EB-CLIN-1001-03 phase 3 clinical trial for the leading biosimilar program EB1001, a Denosumab biosimilar, for the future treatment of osteoporosis, giant cell tumors of bone, and other skeletal-related events from metastatic solid tumors.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: EB1001
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
Luye Pharma Group announced that Denosumab Injection (LY01011), a biosimilar of Xgeva® developed by Shandong Boan Biotechnology has started a comparative clinical study in China. The clinical trials of the drug in Europe and the U.S. are also under way and progressing well.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: LY01011
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 December 16, 2020
Details:
Prolia is Amgen’s treatment for skeletal diseases, osteoporosis and bone loss of cancer patients. The company began to conduct the trial in November, comparing the efficacy and safety of SB16 with the original drug on 432 post-menopausal osteoporosis patients in six countries.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: SB16
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 December 14, 2020
Details:
The approval of XGEVA for the prevention of SREs in patients with bone metastasis from solid tumors and MM was based on clinical results from four randomized international trials that enrolled over 7,000 patients.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: Xgeva
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
The Phase 1 clinical trial for SB16 (denosumab) is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and Prolia® in healthy male volunteers.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: SB16
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2020
Details:
HLX14 can specifically bind to RANKL and block the interaction between RANKL and RANK, expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, maturation and activation of osteoclasts, thereby reducing bone resorption and fractures.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: HLX14
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
This additional investment reflects Amgen's confidence in the progress the companies are making in their ongoing oncology collaboration in China, the world's second largest pharmaceutical market.
Lead Product(s): Denosumab
Therapeutic Area: Oncology Product Name: Xgeva
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $421.0 million Upfront Cash: Undisclosed
Deal Type: Investment July 12, 2020
Details:
The Three-Arm Study is randomized, double-blinded, parallel-grouped, and single-dosed and will compare the pharmacokinetic similarity of JHL1266 versus Prolia® sourced from the EU and the US in healthy human subjects.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
JHL1266, a proposed biosimilar to denosumab, is a monoclonal antibody targeting RANKL and works by inhibiting the development of osteoclasts and then preventing break down of bones in the human body.
Lead Product(s): Denosumab
Therapeutic Area: Musculoskeletal Product Name: JHL1266
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
The stratagic collaboration between Amgen and BeiGene will significantly accelerate Amgen's plans to expand its oncology presence in China.
Lead Product(s): Denosumab
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $2,800.0 million Upfront Cash: $2,800.0 million
Deal Type: Collaboration January 02, 2020
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