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    6600   KYG4271B1023

SCICLONE PHARMACEUTICALS (HOLDINGS) LIMITED

(6600)
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Delayed Hong Kong Stock Exchange  -  05/27 04:08:54 am EDT
8.190 HKD   +0.49%
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NMPA Grants Priority Review to BLA of DANYELZA®

09/10/2021 | 06:09am EDT

SciClone Pharmaceuticals (Holdings) Limited announce that the National Medical Products Administration (the "NMPA") of China has granted priority review to the Biologics License Application (the "BLA") of DANYELZA® (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma. According to the Drug Registration Rules (Order No.27 by the State Administration for Market Regulation) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020 by the NMPA) implemented on July 1, and July 7, 2020, respectively, the regulatory authority will prioritize the review process and resource for applications with expected shorter review timelines when granting priority review. It is a procedure established to encourage research and development of innovative drugs and accelerate the review and approval of new drugs with apparent clinical benefits and urgent clinical needs. The Company entered into a license agreement with Y-mAbs Therapeutics Inc. in December 2020 to be the exclusive co-development and commercialization partner of DANYELZA® (naxitamab) and omburtamab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan. SciClone Pharmaceuticals will be responsible for research and development, registration and commercialization of these two products in such region. In June 2021, the Company had a pilot launch of DANYELZA® (naxitamab) in Hainan Bo'Ao Lecheng International Medical Tourism Pilot Zone. In July 2021, the NMPA accepted the BLA submission of DANYELZA® (naxitamab). On August 7, 2021, DANYELZA® (naxitamab) was administered in its first Chinese patient in Bo'Ao, led by Children's Hospital of Fudan University and in cooperation with Hainan Women and Children's Medical Center. DANYELZA® (naxitamab) is a humanized, monoclonal antibody targeting GD2, a tumor antigen on the cell surface of neuroblastoma. It is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. DANYELZA® (naxitamab) was granted priority review, breakthrough therapy designation, and orphan drug designation, and received accelerated approval based on overall response rate and duration of response from Food and Drug Administration in the United States of America in November 2020. The latest results of STUDY 201 (including 22 patients) which was initiated by Y-mAbs, were published at the 2020 annual meeting of the European Society for Medical Oncology. The results revealed the response rates in relapsed or refractory high-risk neuroblastoma for patients who received DANYELZA® (naxitamab) with GM-CSF. 68% of patients who received DANYELZA® (naxitamab) (15 out of 22 patients) responded to treatment with either a complete or partial response (overall response rate, or ORR). 59% (13 out of 22 patients) showed no physical evidence of disease on imaging tests or upon examination of tissue (complete response, or CR). 9% (2 out of 22 patients) had their cancer reduced by at least half (partial response, or PR). In addition to significant clinical benefit, DANYELZA® (naxitamab) has the advantages of convenient administration and high patient compliance. It has short infusion time (30-60 minutes), which makes it possible to be administered in outpatient setting. There is no requirement of pre-treatment with autologous stem cell transplant ("ASCT") or combination with IL-2 therapy when patients receive DANYELZA® (naxitamab). The NMPA may or may not approve the BLA of DANYELZA® (naxitamab). Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.


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Financials
Sales 2022 2 791 M 417 M 417 M
Net income 2022 895 M 134 M 134 M
Net cash 2022 1 318 M 197 M 197 M
P/E ratio 2022 5,30x
Yield 2022 1,48%
Capitalization 4 735 M 707 M 707 M
EV / Sales 2022 1,22x
EV / Sales 2023 0,96x
Nbr of Employees 890
Free-Float 55,7%
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Number of Analysts 3
Last Close Price 6,99 CNY
Average target price 9,60 CNY
Spread / Average Target 37,3%
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Managers and Directors
Hong Zhao President, CEO & Executive Director
Zhen Fu Li Chairman
Ping Chen Independent Non-Executive Director
Wendy Hayes Independent Non-Executive Director
Guo En Liu Independent Non-Executive Director
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