Mailishu (denosumab biosimilar) / Mabwell (Shanghai) Biosci, Binnopharm - LARVOL DELTA

A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P3 | N=278 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P3 trial • Osteoporosis • Rheumatology

Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. (PubMed, Expert Opin Biol Ther) - P3 | "This study demonstrated that MW031 safely and effectively increased BMD and rapidly decreased the level of bone resorption marker in Chinese postmenopausal women with osteoporosis. NCT05215977 (ClinicalTrials.gov.)."

Clinical • Journal • Osteoporosis • Rheumatology

Maiwei Biotech MW032 is included in the "Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines 2024" [Google translation] (Maiwei Biotech Press Release) - "Recently, a new version of the CSCO series of guidelines was released at the Chinese Society of Clinical Oncology (CSCO) Guidelines Conference. Maiwei Biotech MW032 (desosomeumab injection, trade name: Mailishu) has been included in the 2024 version of the 'CSCO Breast Cancer Diagnosis and Treatment Guidelines'....According to the 2024 version of the 'CSCO Breast Cancer Diagnosis and Treatment Guidelines', denosumab is included in the Class IA recommendation for bone-modifying drugs for breast cancer bone metastases. The guideline states that studies have confirmed the similarity in effectiveness, safety and population pharmacokinetics between denosumab biosimilar (MW032) and the original drug in patients with solid tumor bone metastases. Therefore, the use of bone-modifying drugs is required. For patients, biosimilars of denosumab may also be considered."

Clinical guideline • Breast Cancer • Oncology • Solid Tumor

Maiwei Biotech: Desosumab injection has been approved for marketing by the National Medical Products Administration [Google translation] (Sohu.com) - "According to AI News, on April 3, Maiwei Bio announced that the marketing application for denosumab injection (Maiweijian, 9MW0321) submitted by its wholly-owned subsidiary Jiangsu Taikang Biopharmaceutical Co., Ltd. was approved by the National Medical Products Administration, used to treat giant cell tumors of bone that are unresectable or that may result in severe functional disability after surgical resection, including adults and adolescent patients with skeletal maturity (defined as at least 1 mature long bone and weight ≥45kg). It is the first approved drug in China."

Non-US regulatory • Oncology • Solid Tumor

Mabwell Publishes the Phase III Study Results on Its Denosumab Biosimilar (MW032) in the journal JAMA Oncology (PRNewswire) - P3 | N=700 | NCT04550949 | Sponsor: Qilu Pharmaceutical Co., Ltd. | "Mabwell...recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology....The results showed that the mean change of uNTx/uCr from baseline to week 13 was −72.0% in the MW032 group and −72.7% in the control group. After adjusting for stratification factors, the LSM (least squares mean) difference of these logarithmic transformed percent changes was 0.02. The 90% CI for the difference (−0.04 to 0.09) was within the equivalence margin. Sensitivity analyses of the primary end point, subgroup analysis, and secondary end points analysis demonstrated similarity in efficacy between the two treatment groups."

P3 data • Oncology • Solid Tumor

Efficacy, Safety, and Population Pharmacokinetics of MW032 Compared With Denosumab for Solid Tumor-Related Bone Metastases: A Randomized, Double-Blind, Phase 3 Equivalence Trial. (PubMed, JAMA Oncol) - P3 | "Availability of denosumab biosimilars may broaden the access to denosumab and reduce the drug burden for patients with advanced tumors. ClinicalTrials.gov Identifier: NCT04812509."

Clinical • Journal • P3 data • PK/PD data • Oncology • Solid Tumor

The World's Second Approved Biosimilars of Denosumab (MAILISHU) (PRNewswire) - "Mabwell...announced that the Denosumab solution for injection (trade name: MAILISHU, project code: 9MW0311), which is developed by its wholly-owned subsidiary T-mab, has been formally approved for marketing by the National Medical Products Administration (NMPA) (Approval No.: S20233111). MAILISHU is the world's second approved Biosimilars of Denosumab for the osteoporosis in postmenopausal women at high risk of fracture."

Non-US regulatory • Osteoporosis

Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial. (PubMed, Expert Opin Biol Ther) - P1 | "This trial confirmed similar pharmacokinetic profiles of MW031 and denosumab in healthy male participants, and pharmacodynamic profile, immunogenicity and safety were comparable for both drugs. NCT04798313; CTR20201149."

Clinical • Journal • PK/PD data

Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P3 | N=708 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Mabwell Bioscience Partners with Binnopharm Group to Market 9MW0113, 9MW0321 and 9MW0311 in Russia and Eurasian Economic Union Countries (PRNewswire) - "Mabwell Bioscience...announced the company has entered into an licensing agreement with the Russian pharmaceutical company Binnopharm Group, for 9MW0113, 9MW0321 and 9MW0311, its Adalimumab and Denosumab biosimilars, under which Binnopharm Group will have exclusive rights to develop, register, manufacture and market the drugs with a status of local product in Russia and Eurasian Economic Union countries."

Licensing / partnership • Immunology • Oncology • Osteoporosis

Directly to the performance meeting | Maiwei Bio (688062.SH): Anti-Nectin-4 ADC has obtained the implied license for clinical trials of the State Food and Drug Administration and the approval for clinical trials of the FDA [ Google Translate ] (Zhitong Finance) - "Zhitong Finance APP was informed that on September 9, Maiwei Bio (688062.SH) stated at the performance briefing that the anti-Nectin-4 ADC (the company's internal R&D code is 9MW2821) is an ADC coupling with independent intellectual property rights. The technology realizes the innovative fixed-point conjugated drug of chemical modification; as of the disclosure date of the semi-annual report, 9MW2821 has obtained the implied license of the State Drug Administration for clinical trials and the clinical trial approval of the US Food and Drug Administration. Progress is at an international lead....Among them, two denosumab biosimilars have internal R&D codes 9MW0311 and 9MW0321, respectively. Marketing approval is expected in 2023."

Non-US regulatory • Oncology • Solid Tumor

The similarity of pharmacokinetics, pharmacodynamics, safety, and immunogenicity between recombinant fully human anti-RANKL monoclonal antibody injection (MW032) and denosumab (Xgeva®) in healthy Chinese subjects: A single-center, randomized, double-blind, single-dose, parallel-controlled clinical study. (PubMed, Int Immunopharmacol) - "This study evidenced that the PK profiles of MW032, a denosumab biosimilar, and Xgeva® were bioequivalent. We also found that the PDs, safety, and immunogenicity were similar between the two drugs. Therefore, our results supported the next confirmatory studies for the development of MW032."

Clinical • Journal • PK/PD data

Efficacy and Safety of MW031 in PMO Subjects (clinicaltrials.gov) - P3 | N=448 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P3 trial • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P3; N=706; Active, not recruiting; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Clinical • New P3 trial • Oncology • Solid Tumor

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults (clinicaltrials.gov) - P1; N=120; Completed; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Clinical • New P1 trial • Oncology • Osteosarcoma • Solid Tumor

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults (clinicaltrials.gov) - P1; N=120; Completed; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Clinical • New P1 trial • Osteoporosis • Rheumatology