CMAB007 (omalizumab biosimilar) / Mabpharm Limited, Jemincare - LARVOL DELTA

To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P3 | N=392 | Recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P3 | N=392 | Not yet recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

New P3 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Randomized, Single-Dose, Parallel-Controlled Phase I Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "The incidence of treatment-emergent adverse events and treatment-related adverse events were similar between the 2 groups, with no serious adverse events. This study shows that the test drug had similar pharmacokinetics, immunogenicity, and safety to the reference omalizumab in healthy male subjects."

Clinical • Journal • P1 data

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity (clinicaltrials.gov) - P1 | N=114 | Completed | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

New P1 trial

Jemincare obtains the exclusive right to promote Mabpharma's omalizumab drug in the Chinese market (Eastmoney.com) - "Jemincare Group announced that Jiangxi Jemincare Pharmaceutical...has reached an agreement with Taizhou Mabtech Pharmaceutical...According to this exclusive commercialization cooperation agreement, Jemincare will obtain the exclusive promotion rights of Mabro Pharmaceuticals CMAB007 (omalizumab) in the Chinese market (including Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region of Mainland China)."

Licensing / partnership • Asthma • Respiratory Diseases

Maibo Pharmaceutical-B (02181): The National Medical Products Administration accepts the marketing registration application of the core product CMAB007 (omalizumab) [Google translation] (jrj.com) - "Maibo Pharmaceutical-B (02181) issued an announcement. Recently, one of the company's core products, CMAB007 (omalizumab), was approved by the China National Medical Products Administration (NMPA) for its marketing registration application (NDA) accepted for the treatment of allergic asthma....The safety and efficacy of CMAB007 have been confirmed by a total of 4 clinical trials with a total of 824 subjects receiving CMAB007....The company currently expects CMAB007 to be approved by the State Food and Drug Administration in the fourth quarter of 2022."

Non-US regulatory • Asthma • Respiratory Diseases

Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma. (clinicaltrials.gov) - P3; N=393; Completed; Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.; Enrolling by invitation ➔ Completed; Trial completion date: Nov 2020 ➔ Mar 2021

Clinical • Trial completion • Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety (clinicaltrials.gov) - P1; N=114; Completed; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd; Active, not recruiting ➔ Completed

Clinical • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comments on 2020 performance of 30 biotech companies in Hong Kong stocks [Google translation] (Sina Pharmaceutical News) - "During the reporting period, CMAB007 is implementing phase III clinical trials for the treatment of allergic asthma. As of December 31, 2020, the company is in the final stage of clinical trials....The company is implementing a head-to-head phase I comparison study with the currently marketed omalizumab product to confirm the similar pharmacokinetic characteristics and immunogenicity of CMAB007....CMAB007 is expected to expand its indications to chronic idiopathic disease in the future, sexual urticaria and seasonal allergic rhinitis....They will submit a drug listing application to the State Food and Drug Administration in the third quarter of 2021. The company currently expects CMAB007 to be approved by the State Drug Administration in the second quarter of 2022."

Non-US regulatory • Trial status • Allergic Rhinitis • Asthma • Respiratory Diseases

Maibo Pharmaceutical-B (02181) annual loss attributable to shareholders reduced by 8.8% to 185 million yuan [Google translation] (Sina Pharmaceutical News) - "Maibo Pharmaceutical-B (02181) announced its 2020 annual results. During the period, the company achieved other income of 32.237 million yuan...The loss attributable to company owners was 185 million yuan...The decrease in R&D expenses was mainly due to the fact that the company had completed the clinical trial of CMAB008 at the end of 2019 and had substantially completed the recruitment of CMAB007 cases, which resulted in a decrease in contract costs and raw material cost."

Commercial • Asthma • Respiratory Diseases

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety (clinicaltrials.gov) - P1; N=114; Active, not recruiting; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

Clinical • New P1 trial • Asthma • Immunology • Respiratory Diseases

Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma. (clinicaltrials.gov) - P3; N=400; Enrolling by invitation; Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.; Trial completion date: Dec 2019 ➔ Nov 2020; Trial primary completion date: Dec 2019 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date