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Clarification for news of CCSB successful development " Remdesivir " API. date : 2020/04/16

 

Provided by: Chunghwa Chemical Synthesis & Biotech Co., Ltd.

 

SEQ_NO

1

Date of announcement

2020/04/16

Time of announcement

  18:45:46

Spokesman:

WANG,KUAN-CHIEH

Title of Spokesman:

Finance Manager

Subject

Clarification for news of CCSB successful development " Remdesivir " API.

To which item it meets

paragraph 51

Date of events

2020/04/16

Statement

1.Date of occurrence of the event:2020/04/16

2.Company name:Chunghwa Chemical Synthesis & Biotech Co.,Ltd.

3.Relationship to the Company (please enter ”head office” or

  ”subsidiaries”):Head office

4.Reciprocal shareholding ratios:N/A

5.Name of the reporting media:Economic Daily NewsLiberty Times Net

 Infotimeswww.investor.com.twbreaknews

6.Content of the report:

 ” In terms of the preliminary clinical report of Remdesivir showing

 promising result towards to the treatment of COVID-19 patients with

 severe symptoms, CCSB (Chunghwa Chemical Synthesis & Biotech Co. Ltd.),

 one of the biggest API manufactures in Taiwan, announced on Apr 15th

 that the development of the lab scale batch has been successfully

 completed. Three batches of Remdesivir has been produced with purity

 99.72% in lab and obtained 4.73 g in total (1.60 g, 1.55 g, and 1.58 g,

 respectively).

 CCSB and CCPC (China Chemical & Pharmaceutical Co., Ltd.) will devote

 our efforts and capabilities to the mass production of Remdesivir as

 soon as the government calls for our instant assistance and supports.

7.Cause of occurrence:

 CCSB participated the project of Taiwan FDA, Influenza Vaccine

 Production Process Improvement Project in 2007, and successfully

 delivered 40kg Tamiflu API on time. Based on the successful

 experience, CCSB focuses on the production research of Remdesivir to

 implement CSR when people all over the world have being suffering from

 the outbreak of COVID-19 since February 2020.

8.Countermeasures:

 CCSB already completed the laboratory process of Remdesivir, proving

 that CCSB has the ability of development.

 Remdesivir hasn't been launched officially in the market yet as well

 as in the originator's clinical stage.

 CCSB does not plan the launch time of Remdesivir now but will wait

 for the clinical results.

 CCSB will fully cooperate and support to government's policies, that

 won't cause any significant impact on our finances and sales.

9.Any other matters that need to be specified:

 New product development completion date:

 lab scale manufacturing method has been completed on 04/14/2020.

 New product information:

 CCSB has synthesized 3 lots of Remdesivir, a total of 4.73 grams

 with 99.72% purity.

 Impact on company finance and business:

 That won't cause any significant impact on our finances and sales.