Ph PharmaEssentia Corp. announced the 52-week result of the phase II clinical trial of Ropeginterferon alfa-2b (P1101) for the treatment of Polycythemia Vera (PV) in China. Study title: A Phase II Single-Arm Multicenter Study to access Efficacy and Safety of P1101 in Chinese Polycythemia Vera ("PV") patients who are Intolerant or Resistance to Hydroxyurea (HU).

objectives: The primary objective is to evaluate the efficacy and safety of P1101 in the treatment of Chinese PV patients with HU resistance or intolerance. Phase II clinical trial is approved by the China National Medical Products Administration (NMPA) to recruit 49 Chinese PV patients for a 52-week course of treatment. The primary endpoint is the phlebotomy- or erythrocytapheresis-free complete hematologic response (CHR) rate at week 24 based on the central laboratory test results evaluation.

Number of subjects: 49 Chinese PV patients. The statistical results (including but not limited to P value) and statistical significance (including but not limited to whether statistical significance is achieved) of the primary and secondary endpoints. If the Company cannot disclose statistical data due to other important reasons, the reasons should be stated.

This clinical trial is approved by theChina National Medical Products Administration (NM PA) to recruit 49 Chinese PV patient for a 52-week course the primary endpoint is the phle botomy- or erythroCytapheresis-free CHR rate at week 24 based onthe central laboratory test results evaluation.; the secondary endpoint is the phlebotization- or erythrocy tapheresis-free complete Hematologic response (CHR) rates at week 12, 36, and 52 based on central laboratory test results evaluation. In terms of efficacy, of the total 49 subjects, 35 subjects achieved CHR at week 52 with the CHR rate 71.43% (35/49) based on intention-to-treat (ITT) set; the statistical significance of the primary endpoint is achieved, and numerically higher than the CHR rate of 43.1% at the 52nd week of PROUD-PV. The CHR rates at week 12, 24 and 36 are 44.90% (22/49), 61.22% (30/49), and 69.39% (34/49) respectively.

The CHR rate increases with the prolongation of P1101 treatment time. Regarding safety, only 10 subjects experienced drug-related treatment-emergent adverse events (TEAE) during the study, most of TEAE are grade 1-2. In summary, P1101 demonstrates good safety and tolerability. If statistical results of the phase III clinical trial of the new drug is disclosed, the marketing plan of the Company:N/A. The results of a single clinical trial (including the statistical P- values of t the primary and secondary endpoints and whether they are statistically significant) are not sufficient to fully reflect the success or failure of the launch of the new drug.

Investors are advised to exercise caution and conduct thorough evaluation. R risks and mitigation measures to be taken by the company upon approval by the competent authority:N/A. Strategic strategies to be taken by the company Upon approval by the competent authority: The Company submitted the marketing authorization. The Company submitted the marketing authorization and approval by the company's marketing authorization and approval by the Company.