Genting Sunshine announces annual results for the year ended December 31, 2020

• Development achievements during the reporting period:

• (Expected) milestones and achievements after the reporting period:

• Development achievements during the reporting period:

• (Expected) milestones and achievements after the reporting period:

Eravacycline (XeravaTM) is a new, fully synthetic, fluorotetracycline-containing intravenous antibiotic.
It is a first-line single-agent therapy for the treatment of multidrug resistance (MDR) infections (including MDR gram-negative infections) And the developed product
.

• Development achievements during the reporting period:

On October 27, 2020, Genting Shinya has completed the Phase 3 bridging clinical trial of elacycline for the treatment of cIAI in China.
The trial enrolled 144 patients
.

• (Expected) milestones and achievements after the reporting period:

The State Food and Drug Administration of China has accepted the drug marketing authorization application for elarcycline for the treatment of cIAI in China in March 2021.
This is the first drug marketing authorization application submitted by Genting Xinyao in China
.

Other assets

• (Expected) milestones and achievements after the reporting period:

Genting Xinyao expects to announce the key data analysis results of the global phase 3 clinical trial of Taniborbactam for complex intraperitoneal infection (cUTI) in 2021
.

Genting Xinyao plans to initiate a phase 2 clinical trial of FGF401 for the treatment of hepatocellular carcinoma in China in the second half of 2021
.

Company development

In January 2021, Genting Shining and Spero Therapeutics reached an amendment to the license agreement.
According to the revised content of the agreement, Genting Shining will obtain related patents for the candidate product SPR206 in Greater China, South Korea and some Southeast Asian countries.
Equity
.
SPR206 is an innovative treatment option for MDR Gram-negative bacterial infections and is still in clinical development
.

On February 18, 2021, Genting Shinyao appointed Guo Yong as its chief commercial officer
.
Mr.
Guo has over 22 years of extensive experience in leadership and business management in a number of multinational pharmaceutical companies
.

According to the latest index series announced by the Hang Seng Indexes Co.
, Ltd.
, Genting Sunshine is included as a constituent stock of the Hang Seng Composite Index, Hang Seng Healthcare Index and Hang Seng Hong Kong Listed Biotechnology Index, effective from March 15, 2021
.
Being included in the above-mentioned Hang Seng Index indicates that the company has met the criteria for being included in Southbound Trading, and Southbound Trading is a channel for stock trading and investment between Hong Kong and the majority of Chinese capital market investors
.

future development

Genting Xinyao will continue to build a top biopharmaceutical company focusing on the development and commercialization of global innovative therapies, starting from Greater China and other markets in the Asia-Pacific region
.
In order to achieve the goal, Genting Shinyao will work hard to advance and complete the registration trials of existing drug candidates, and seek the most effective way of approval
.
At the same time, Genting Sunshine will continue to expand its innovative drug product portfolio in selected therapeutic areas with a large number of unmet medical needs by introducing authorizations and building its own R&D capabilities
.
In order to support a variety of late-stage products that are about to be launched, Genting Xinyao has begun to form a business team with extensive knowledge of sales, operations and market access strategies in different therapeutic fields
.
In addition, Genting Sunshine is establishing its own GMP/GSP production facilities in China to ensure long-term stable and adequate drug supply and optimize product costs
.

Financial summary

IFRS figures

• For the year ended December 31, 2020, the Group’s research and development expenditure increased by RMB 226.
  5 million from RMB 150.
  9 million for the year ended December 31, 2019 to RMB 377.
  4 million, mainly due to the It is caused by the additional clinical trials of the candidate drug and the expansion of the R&D team
  .
  
• For the year ended December 31, 2020, the Group’s general and administrative expenses increased by RMB 223.
  9 million from RMB 53.
  9 million for the year ended December 31, 2019 to RMB 277.
  8 million, mainly due to the initial The public offering (initial public offering) expenses and the expansion of the organization team resulted in the increase in employee salaries
  .
  
• For the year ended December 31, 2020, losses arising from changes in the fair value of financial instruments issued to investors increased from RMB 36.
  5 million for the year ended December 31, 2019 by RMB 4,901.
  5 million to RMB 4,938.
  0 million.
  Ten thousand yuan, mainly due to the substantial increase in the fair value per share when the company remeasured the convertible redeemable preferred shares previously issued to investors after the completion of the initial public offering
  .
  
• The net loss for the year ended December 31, 2020, increased from RMB 214.
  5 million for the year ended December 31, 2019 to RMB 5,658.
  2 million, mainly due to the fairness of financial instruments issued to investors The value change resulted in a loss of RMB 4,938.
  0 million, which was a non-cash one-off adjustment after listing in accordance with International Financial Reporting Standards (International Financial Reporting Standards)
  .
  

Non-IFRS measurement:

• The adjusted loss for the year[1] for the year ended December 31, 2020 was RMB 602.
  9 million, an increase of RMB 439.
  8 million from RMB 163.
  1 million for the year ended December 31, 2019, mainly due to research and development Due to the increase in expenses and general and administrative expenses
  .
  

Adjusted loss for the year refers to the loss for the year attributable to equity holders of the company that does not take into account the impact of certain non-cash items and one-off events, that is, the loss arising from changes in the fair value of preferred stocks (non-current financial Liabilities) and share-based compensation losses
.