3SBio Announces 2021 Annual Report: Net Profit attributable to Parent Nearly Doubled, Accelerated Development of Diversified Businesses

The core business continued to grow, and potential products were declared for listing

In 2021, 3SBio's main business revenue will maintain growth for 5 consecutive years, with a compound annual growth rate of 14.

TPIAO achieved sales revenue of 3.

The total sales revenue of EPIAO and Cyboer reached 1.

Yisaipu's exchange of price for volume has achieved a remarkable effect, achieving sales revenue of 790 million yuan, a year-on-year increase of 28%, and a year-on-year increase of 90% in sales volume

The potential core product, Remitch, has submitted a marketing application and has been accepted

Strong growth in hair health business, all channels go hand in hand

Driven by the current "face value economy", the problem of hair loss has become the focus of more and more people, and the hair health market has given birth to huge market potential

Mandi, a hair loss treatment product of 3SBio, has grown rapidly in recent years

Mandy's rapid growth in 2021 will benefit from several aspects

First, the coverage of medical institutions continues to expand

Second, the coverage of retail pharmacies is further expanded

Third, the rapid growth of e-commerce channels

Fourth, at the same time, Mandy's new dosage form products are also about to be launched

There are 250 million people with hair loss in mainland China, and the current penetration rate of Mandi is only 1%-2%

Breakthroughs have been made in R&D progress, and license-out has reached a milestone

In 2021, 3SBio’s R&D progress will be further accelerated, with a total investment of 750 million yuan in R&D throughout the year, an increase of nearly 28% compared to last year

The progress of key projects in the submission of new drug applications and Phase III clinical trials include:

• The anti-TNF-α pre-filled Yisaipu water injection (301S) has resubmitted the NDA production approval to the State Food and Drug Administration in July 2021, and has been accepted
  .
  
• Minoxidil foam formulation (MN709) completed a multicenter, randomized, and double-blind phase III study comparing MN709 and Rogaine® in male pattern baldness patients, and obtained positive results.
  The NDA submitted to the State Food and Drug Administration has been accepted
  .
  
• The Phase III clinical trial of Nafuraphine Hydrochloride Orally Disintegrating Tablets (TRK820) for the treatment of refractory pruritus in maintenance hemodialysis patients reached the preset endpoint, and the conclusion was consistent with the results of the Phase III trial in Japan.
  The Office submitted an NDA and was accepted
  .
  
• Phase III clinical trial of TPIAO (TPO) started for pediatric ITP; Phase I clinical trial for perioperative mobilization of patients with chronic liver dysfunction at risk of thrombocytopenia has been completed, and Phase Ib/II clinical trial is in progress In progress
  .
  
• NuPIAO (EPO, SSS06) has completed the Phase II clinical trial and obtained data results, and has started the Phase III clinical trial of the product in November 2021, and will start patient enrollment before the end of 2021
  .
  

The key project progress of the Phase II clinical trial includes:

• Peg-EPO (RD-01) has completed a dose-escalation safety and pharmacokinetics Phase I clinical study of RD-01 in healthy volunteers
  .
  Patient enrollment for the Phase II clinical trial was completed by the end of December 2021
  .
  
• The anti-PD1 monoclonal antibody (609A) completed the US Phase I clinical trial of 609A for the treatment of multiple types of cancer patients
  .
  Phase II clinical trials in Mainland China are underway
  .
  
• The phase II trial of anti-IL17A mAb (608) in the treatment of plaque psoriasis has completed patient enrollment and is expected to initiate a phase III trial by the end of 2022
  .
  The company has submitted an IND application for 608 for the treatment of axial spondyloarthritis (SpA) in March 2022
  .
  
• The anti-VEGF monoclonal antibody (601A) is already advancing a Phase 3 clinical trial of 601A in patients with BRVO
  .
  
• Anti-EGFR monoclonal antibody (602) has completed two clinical phase I clinical trials in healthy volunteers and colorectal cancer patients respectively, and has started the phase II clinical trial of this product in colorectal cancer patients, and the patients are enrolled in the work Completed in October 2021
  .
  
• The indication of anti-IL1β monoclonal antibody (613) for acute gout was approved by the National Medical Products Administration, and the Ib/Phase II trial is in progress
• Anti-HER2 monoclonal antibody (Initumumab, 302H) In May 2021, the company's Phase I/II clinical trial of 302H combined with 602 in HER2-positive, KRAS/NRAS/BRAF wild-type colorectal cancer patients was approved by the State Food and Drug Administration Approval; clinical trial of 302H combined with IMM01 (SIRPα-Fc fusion protein targeting CD47 currently under development by Immune Onco) in the treatment of HER2-positive solid tumors was also approved
  .
  

The key project progress of Phase I R&D and IND application includes:

• A phase I clinical trial of HIF-117 (SSS17) for the treatment of anemia is ongoing
  .
  
• A Phase Ib trial of anti-IL5 mAb (610) in asthma is currently enrolling patients
  .
  ;
• The dose-escalation Phase Ia clinical trial of anti-IL4Rα mAb (611) on healthy volunteers has been completed in the United States, and the Phase Ib study of atopic dermatitis patients in mainland China will be completed shortly
  .
  
• Anti-HER2 monoclonal antibody (612) obtained IND approval from the State Food and Drug Administration
  .
  
• Anti-PSGL-1 mAb (617) received IND approval from the State Food and Drug Administration for the treatment of advanced solid tumors
  .
  
• IND applications for anti-PD1xHER2 bispecific antibody (705) were approved by FDA and NMPA, respectively
  .
  
• IND applications for anti-PD1x anti-PD-L1 bispecific antibody (706)) were approved by the FDA and NMPA, respectively
  .
  

In the future, the company will continue to focus its resources on the four core therapeutic areas of autoimmune diseases, oncology, nephrology and dermatology
.
Among them, the pipeline in the field of autoimmunity includes anti-IL-4Rα antibody, anti-IL-5 antibody, anti-IL-1β antibody and anti-IL-17A antibody and other products that are in the first echelon in China
.

At the same time, the company's overseas cooperation continues to deepen: In 2021, the company submitted an IND application to the CDE for the PSGL-1 antibody introduced from Verseau in the United States and obtained the IND approval in March 2022; at the end of the year, the company introduced a potential antibody from Switzerland's Numab company.
first-in-class, bivalent CD3 T cell engager targeting mesothelin
.
These foreign cooperation will be an important cornerstone of the company's future internationalization
.
On January 4, 2022, 3SBio and Syncromune Corporation of the United States reached an agreement to license the global rights of the anti-PD-1 monoclonal antibody 609A developed by 3SBio for use in the tumor immune combination therapy syncrovax® to Syncromune Corporation of the United States
.
According to the agreement, Sunshine Guojian is expected to obtain hundreds of millions of dollars of down payment, milestone payment and other incentives based on the clinical value prospects, important regulatory and sales milestones, and other commercialization value of 609A, and continue to maintain 609A in any global syncrovax? The rights and interests other than therapy have achieved the breakthrough of the company's innovative drug license-out milestone
.

CDMO business is making steady progress, and follow-up production capacity is ready to go

3SBio is one of the earliest companies in China to carry out R&D and production of biological drugs.
Over the past 29 years, 3SBio has accumulated rich experience in quality control and excellent production facilities and production processes
.
In recent years, the company has continuously expanded its CDMO business to empower more biopharmaceutical companies
.
In 2021, the company's CDMO business will achieve revenue of 110 million yuan, a year-on-year increase of 4.
6%.
The overseas CDMO business composed of European subsidiary Sirton and other overseas customer services accounts for a higher proportion, but domestic customer revenue has increased significantly
.

At present, the company's CDMO business consists of North Pharmaceutical Valley Desheng (Shenyang) Biotechnology Co.
, Ltd.
(Desheng Bio), Shanghai Shengguo Pharmaceutical Development Co.
, Ltd.
(Shenguo Pharmaceutical), and Italian Sirton
.
Among them, Desheng Bio has a total planned area of ​​500 mu, aiming to build a domestic leading biopharmaceutical CDMO base and biopharmaceutical raw and auxiliary materials for the international market that meet the requirements of relevant GMP regulations in China, the European Union and the United States.
And consumables manufacturing base and biopharmaceutical core process equipment base
.
The Phase I project of Desheng Biology covers an area of ​​more than 110 acres.
It is planned to build a 199,000-liter stock solution production line and a cumulative annual injection capacity of 100 million doses.
The first phase of the 76,000-liter production capacity is expected to start production in 2022
.
The group CDMO has rich experience in the development of protein drug stock solution (DS) and finished product (DP) and the production capacity from laboratory to ultra-large-scale production.
It can provide customers with a one-stop for the whole process from DNA to IND to BLA and commercial production.
type CDMO service
.

In the future, 3SBio will rely on the company's technological advantages in the whole process from R&D to production of biopharmaceutical products over the years, the large-scale cost advantage brought by a single 10,000-liter bioreactor, and self-produced raw materials such as culture medium and chromatography packing.
The advantages of production cost and high automation level of quality control management have further expanded the CDMO business territory, and is committed to building a comprehensive biomedical CDMO covering macromolecular biopharmaceuticals, gene therapy and cell therapy
.

Dr.
Lou Jing, Chairman of 3SBio, said: "In 2021, despite the fluctuations in the external environment, the Group's management and governance will be orderly, rigorous and efficient, and the four business areas will go hand in hand.
Real returns
.
Looking forward to the future development strategy, the Group will continue to deepen the grassroots market in marketing and promote the optimization of the drug structure for chronic diseases; In terms of cooperation, actively seek products to go overseas to meet the competition and rewards of the global market
.
3SBio Group aims to meet the unmet clinical needs, and is committed to meeting the practical needs of China's aging society and the people's ardent yearning for a better life , and strive to achieve the common growth of social responsibility and company performance, and create greater value for shareholders and society
.
"

Cautionary Note and Forward-Looking Statements

This press release contains forward-looking statements, such as those concerning business and product prospects, or the company's intentions, plans, perceptions, expectations and strategies
.
These forward-looking statements are based on information currently available to the Company and are forward-looking statements at the time of this press release
.
These forward-looking statements are based on certain projections, assumptions and assumptions, some of which are subjective or beyond our control
.
Such forward-looking statements may prove to be incorrect or may not materialize in the future
.
With regard to any new product or product for a new indication, we cannot guarantee that it will be successfully developed or eventually marketed
.
These forward-looking statements are subject to various risks and uncertainties
.
Our other public disclosure documents may provide additional information on these risks and uncertainties
.
The scientific information involved may only be preliminary and research
.
Shareholders and potential investors of the Company should exercise caution when dealing in the shares of the Company
.