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S.C.P.C Investor Presentation 2020

Nov 19, 2020

51900_rns_2020-11-19_a000b1a8-7ce5-43d8-a6c1-0bdbee5701f8.pdf

Investor Presentation

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Stock Symbol :1720

Standard Chem. & Pharm. Co., Ltd. (SCP) Investor Roadshow

2020.11.19

1

免責聲明 Safe Harbor Notice

本次簡報與討論包含特定預測性的說明,而其內容有關於營運結
果、財務狀況,以及對未來事件的預期。因為此等前瞻性說明是有關
於未來事件,而且取決於未來發生時的環境因素,所以必然含有風險
與不確定性。
本公司將不負擔公開更新或修改這些預測性的說明之義務,無論是
出現新資訊、未來發生任何事件,或其他情況。實際結果可能與此等
預測性說明推測的內容有重大差異。

In these presentations and discussions, there are certain forward looking statements regarding the results of operation, financial condition and current expectation about future events. As forward-looking statements relate to events and depend on circumstances in the future, they involve risk and uncertainty. We do not undertake any obligation to publicly revise or update any forward looking statements for availability of new information, future events or otherwise. Real result probably differ substantially from those expected in these forward-looking statements.

2

Agenda

Corporate Introduction to 2020 Q3 Forward-Looking Social Standard Group Operating s Strategie Responsibility (SCP Group) Results (CSR)  Milestones  Consolidated • Drivers of  Fan Dao Nan Financial Revenue Foundation  Resource Statements Growth Integration • • Status of Forward Past Internationaliza looking Financial tion Strategy Performance

3

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Introduction to Standard Group (SCP Group)

4

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International Accreditation

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1998 2000 2008 2009 2010 2017 2018
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The first TW pharmaceutical company to be ISO9001 certified

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The first TW company to pass US FDA inspection

SCP passed subsequent US FDA cGMP inspections without 483

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SCP received JP PMDA’s “Certificate Y2018 FDF Plant and API Plant of Foreign Drug Manufacturer” passed PMDA GMP Audit

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SCP’s API plant passed AU TGA inspection

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Y2010 SCP passed TW PIC/S GMP inspection Y2012 SCP is certified GDP by the T-FDA

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Y2012 SCP passed K-FDA inspection

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SCP and Related/Affiliated Companies

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1967 1982 1995 1999 2005 2016 2019
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SCP is established in Became TWSE listed company (1720) 1967 Syn-Tech is established Became listed company at in 1982 OTC market (1777) Syngen is established Became listed company at in 1999 OTC market (8279) Invested to Multipower in 2012 Invested to Your Chance Pharmacy in 2013 Taiwan Biosim is established in 2017

6

SCP Group Resource Integration

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Pharmace
uticals
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Medical
Equipments
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Software/Hardware service Inforight Technology

7

53 Years of Continuous Profit (Profit and Dividend Performance in past 15 years)

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EPS
(Expressed in thousands of New Taiwan Dollars)
Net Income Cash Dividend Stock Dividend EPS
400,000 3.00
350,000
2.50
2.09 [2.15 ] 2.09
300,000 2.04
1.95 1.90 [2.03 ][2.09 2.11 ]
1.77 [1.81 1.88 ] 2.00
250,000 1.61 [1.73 ]
1.56
1.35 [1.47 ]
200,000 1.50
150,000
1.00
100,000 1.20 1.50 1.25 1.20 1.60 0.50 1.00 1.20 2.50 1.00 1.50 1.50 1.60 1.50 1.50
0.50
50,000 0.70
0.30 0.30
0 0.00
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(Expressed in thousands of New Taiwan Dollars)

8

(1777) Historical Milestone Syn-Tech

2000
2004
2014
2019
1995
Passed US FDA
inspection; products
were exported to the
US
Passed ISO14001:
Environmental
Management System
validation
Passed ISO 45001
validation
Awarded by TFDA for
API cGMP Award
2009
Awarded TW
Pharmaceutica
l Industry
Awarded TW
Pharmaceutica
l Industry
R&D Award
Passed subsequent US
FDA and JPPMDA
GMP inspection
R&D Award
1982
2000
2010
2020
1982
Syn-Tech
was founded
1998
Awarded National
Pharmaceutical
Quality Award in
the category of API
plant and Single
Medicine
Passed ISO9001
validation
2002
Awarded Industrial
Sustainable
Excellence Award
Awarded National
Award of Outstanding
SMEs
2018
Top 5% of Corporate
Governance Evaluation
of the listed company at
OTC market for four
consecutive years
2005
Officially
listed in the
OTC market
2011
Awarded the
SMSs
Innovation
Award

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(8279) Syngen Biotech Historical Milestone

2019 2017 2011 2004 Awarded the Copper Prize 2014  Passed US NSF inspection  Awarded the Golden Award of Awarded the Silver of Awarded National The 33[rd] World Genius  Awarded National TW healthcare & Prize of TW agricultural Biotechnology Medical Innovation Award Convention & Education EXPO Pharmaceutical biotech ingredients Quality Award  Awarded by Taipei Biotech innovation  Awarded Golden Prize of Industry R&D Award Awards for the Silver Award of & excellence award TW Pharmaceutical Globalizing Award Industry R&D Award 1999 2000 2015 2020 2016 1999 Officially listed in the Syngen OTC market was 2018 founded 2012  Passed US FDA inspections without 483 2020 Acquired HACCP  Awarded Golden Prize 2010 certificate  Awarded the Golden Prize of Malaysia Passed ISO9001 and ITEX for Outstanding BioIndustry ISO22000 validation  Awarded by Taipei Biotech Awards for the Excellence Award of Globalizing Award

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2020 Q1~Q3 Operating Results

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Income Statement

(Consolidated)

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Balance Sheet (Consolidated)

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Cash Flows (Consolidated)

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Global Revenue Ratio of Past 5 Years (Consolidated)

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Global Revenue Ratio Comparison (Consolidated)

(Expressed in thousands of New Taiwan Dollars)

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2020Q3 2019Q3

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250,000
34% 40%
200,000
27%
150,000
22%
100,000
14%
11%
8%
50,000 6%
5% 6% 4% 6% 4% 6% 5%
3%
0% 0%
0
S.E.A. China Other - Japan Other - U.S.A Europe Africa Other
Asia Americas
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Competitors Cons. Revenue Growth Amount & Growth Rate Ranking for 2020 Q1-Q3

( gro ( gro
282,128

12.6%
9.7%

73%

5.1%
6.5%
(45,356)
2.3%
.
2.4%
6.0%
248,190 135,589 126,398 81,451 63,957 21,507 19,445
(18,398)
(342,557)
08%

-2.4%
-.
-10.2%
S.C.P.C
SYNMOSA
CCPC
SINPHAR
TBC
NANG
KUANG
GBL
JCP
CHI SHENG
Y.S.P.
TTY

17

Comparison of Quarterly Revenue of Past 4 Years (Consolidated)

(Expressed in thousands of New Taiwan Dollars)

2016-2020 Consolidated quarterly revenue

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1,200,000
1,000,000
800,000
600,000
400,000
200,000
0
Season 1 Season 2 Season 3 Season 4
2016 2017 2018 2019 2020
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Consolidate
d Revenue
Season 1 Season 2 Season 3 Season 4 Annual
Statistics
2016 859,024 940,238 919,663 954,876 3,673,801
2017 909,933 976,177 1,056,753 905,821 3,848,684
2018 763,261 897,693 913,353 998,786 3,573,093
2019 846,177 1,010,837 1,048,886 1,031,229 3,937,129
2020 1,034,417 1,108,059 1,045,351 3,187,827

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Forward-looking Strategy

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Future Milestone

Taiwan Generics

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International Better than Generics

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SCP – Major International Businesses of the Past 2 Years

Taiwan China

  • Continues export of antibiotic injection

  • Generic Quality Consistency Evaluation(GQCE) 3 cases were closed; 5 ongoing applications

  • Self-developed generic drug: one was submitted for review; one products passed the BE test

  • Agent for 20 Mylan drugs, including biosimilar and anti-cancer drugs. 2 of them were launched to the market.

  • Continues research & development for high technical threshold biosimilar drugs

Japan

  • Continuous export of Asthma product to Japan

  • Launch of Antiinflammatory Oral Solid Dosage in 2020

Revenue Growth Strategy - Taiwan

  • Taiwan as Base of Operations for Global R&D and Pharmaceutical Manufacturing

  • Export sales growth in 2020

  • Continuous development in US, China, Japan, and ASEAN to maximize the products market share.

 Strengthen Manufacturing Capability

  • Expansion of production line and upgrade equipment

  • Manufacturing line complies with international standards; have passed numerous international audits

  • Production line simplification

 In-licensing:

  • Agent for 20 Mylan anti-cancer drugs in Taiwan; 2 biosimilar drugs have been launched in 2020.

22

Agent for 20 Mylan Anti-cancer Drugs

  • 5 Biosimilar Drugs

  • 3 ingredients, 5 drug licenses

  • 3 drug licenses have been approved in Taiwan, 2 drugs were officially approved with NHIA price

  • 15 kinds of Small Molecule Drugs

  • 9 ingredients, 15 drug licenses

  • 12 drug licenses have been approved in Taiwan with NHIA price

  • Launched to the market in 2020

  • Ogivri was launched on the 1[st] quarter

  • Fulphila was launched on the 3[rd] quarter

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Mylan Ogivri

 Herceptin

  • Breast cancer ranks the 1[st] place for Taiwan female cancer, with the third spot of leading cause of death and an average incremental of 12,000 patient per year in Taiwan

  • The product is ranked 4[th] in global drug sales, and it has taken the first spot of cancer NHIA reimbursement for many years.

  • The product was approved with NHIA price in 2002. Current NHIA Price is NT$46,894 per dose. 2018 annual NHIA expenditure for the product was NT$2.206 billion with 5,030 applicants.

 Mylan Ogivri

  • The product was approved and launched in the U.S. in December 2017, and also approved in Taiwan in December 2018; the sale is commenced in 2020.

  • NHIA reimbursement Price: NT$ 39,860/dose, one dose usage for every 3 weeks, around 18 doses each year

  • 、 、

  • Indication: EBC MBC MGC

 Patient Support Program

  • Patients, who are not covered by health insurance, can apply the support program after doctor’s evaluation to reduce the medical burden.

  • Ovigri is used by medical center and local hospitals.

24

Mylan Fulphila

 Original Drug: Neulasta

  • Indication to help reduce the chance of infection due to a low white blood cell count, while non-myeloid cancer patient receive anti-cancer medicines that can cause fever and low white blood cell count.

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  • Short-acting, 3~10 injections per therapy; Long-acting, 1 injection per therapy
Product Name Dosage NHIA
Price (NT$)
2018 NHIA
Volume
Short-acting:
Filgrastim inj. (Filgrastim)
75µg $623 14,863 inj.
150µg $1,442 24,150 inj.
300µg $1,804 155,671 inj.
Long-acting:
Neulasta inj. (Pegfilgrastim)
6mg $18,158 1,309 inj.

 Mylan Long-acting GCSF: Fulphila(Pegfilgrastim)

  • NHIA Price: NT$15,722. Fulphila is used by hospital

25

Avigan (Favipiravir)

  • The clinical trial shows that it is effective against COVID-19

  • One of the anti-flu drugs

  • Fijifilm Toyama Chemical Co., Ltd. conducted phase III clinical trial in March 2020 and ends in September of the same year. 156 patients were tested.

  • The study shows the improvement of symptoms and that is can shorten the recovery time

  • Application was submitted for partial changes (new indication)

  • Will be the first Japan-made drug to treat COVID-19

 SCP as an exclusive agent in Taiwan

  • The Center of Disease Control imported 5,000 tabs of Avigan (dosage for about 4000 people)

  • Hospitals can submit special import project to TFDA when necessary

  • Japan has increased its production quantity for about 300 thousand people per month

26

Revenue Growth Strategy - China

c

SCP Competitiveness

  • SCP has successful experience with

  • U.S. and Japan regulatory dossiers

  • SCP to continue to specialize

  • expertise in BE design and execution

Mid-Term Goals

 Self-developed products submission  Increase revenue from profitsharing

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NMPA review of importation

  • Continuous export of antibiotic injection products

  • Erectile dysfunction ODT were submitted in 2002

  • Diabetes products passed the BE test. Submission

NMPA Consistency Evaluation

  • 8 contracts signed, 3 cases were closed, and 5 ongoing cases

  • Collaboration Model  Tech-transfer

 Co-development

  • BE Collaboration

  • Profit-sharing Partnerships

Strategies

  • Emphasize export and tech transfer simultaneously.

  • Increase the number of cooperative projects and pharmaceutical companies

27

NMPA Reforms: Generic Quality Consistency Evaluation (GQCE) Progress

 Revised status of GQCE

Period Received # Approved #
2017 73 21
2018 585 85
2019 1,014 207
2020 Jan. to Oct. 812 452
Total 2,484 765

*Source www.yaozh.com Report of CDE Statistics

 Public traded pharmaceutical entities announced the 183 cases were passed; each R&D expenses are as follow: *Source: PharmCube

  • <5 million, 26 cases (14.2%)

  • 5~10 million, 89 cases (48.6%)

  • 10~15 million, 41 cases (22.4%)

  • Above 15 million, 27 cases (14.8%)

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NMPA Reforms GQCEPharmaceutical Companies’ Tendency

 Mostly applied by group company self-developed API, and massive R&D expenditure

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Company Name Top 7 companies’ cases approved under GQCE
齊魯製藥 15 25
中國生物… 11 25
揚子江藥業 22 13
石藥控股 17 15
四川科倫… 14 11
18 4
上海復星…
9 13
浙江華海…
0 5 10 15 20 25 30 35 40
補充申請 新註冊分類
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NMPA Reforms: Centralized Procurement of Drugs

  • 112 drugs were announced to be included in the Centralized Procurement list

  • Sept. 2019: 1[st] group of 25 drugs were listed

  • Dec. 2019: 2[nd] group of 32 drugs were announced

  • Aug. 2020: 3[rd] group of 55 drugs were announced

 Centralized Procurement Area:

  • Expending from 4+7 (11 major cities) to countrywide

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NMPA Reforms: Market Tendency

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Hospitals are
Encourage
encouraged to use
hospitals to
listed drugs via health
prioritize
insurance fund
the usage of
listed drugs
Eligible companies
increases from 6 to
8 firms.
Increase Constant
eligible price cut
companies on drugs
There is an average of
70% price cut on 3 [rd]
group of listed drugs
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Revenue Growth Strategy - Japan

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Collaboration Model

 Japanese Distribution Partner  Contract Development, and Manufacturing

 License Holder

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Raw Material Strategy

 Strategic alliance with API manufacturer.

 API Vertical Integration with Syn-Tech.

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Current State

On Going

 Obtained marketing licenses

 NT$50million sales in 2020

for Montelukast (Asthma) and Celecoxib (Antiinflammatory)

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Revenue Growth Strategy – U.S.A.

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U.S.A. Market

  • Largest Rx Market

  • Characterized by lengthy review timelines and costly compilation and filing work

  • SCP’s long term goals

Strategy

  • Strategic alliance with API manufacturer.

  • API Vertical Integration with Syn-Tech.

Current Status

  • Export of diabetic and amyothophic lateral sclerosis(ALS) drugs treatment

  • Another approved drug, pending for patent expiration

Forward-looking Strategy Layout

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Future:
2018 2020 2020
International
China Japan U.S.A.
Better-than-Generics
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Increase
International
Revenue Ratio
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  • Increase international

  • business resources

  • Recruit international talents

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Core technology and
professional development of
international performance
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  • Utilize Taiwan’s cutting-edge R&D technology to enhance potential revenue .

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Leverage
Competitiveness in
Overseas Markets
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  • Stable foundation

  • Rapid revenue creation

  • Step-by-step optimization for minimization of loss

  • Focus on market knowledge and business acumen

  • Establish strategic

partnerships for mid- and long-term goals

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2020.10.27

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Corporate Social Responsibility

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Fan Dao Nan Foundation

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Fan Dao Nan Foundation

 Established in 1987

 Endowment Fund: NT$196 Million

 Annual Budget: NT$12 Million

Principal Activities

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 Non-profit education

 Cultural and educational development activities

 Scholarships and Talent Cultivation  Sponsor R&D and Innovation

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Rewards and Honors Received

 2011: Special Recognition Award – Dept. of Education

 2012: Tainan City Govt. Grant for Scholarship Program

 2013: National Special Selection Award for After-School Program – Dept. of Education

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Corporate Social Responsibility

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Scholarships

 University (related fields): 2 universities/5 students  High school: 8 schools/108 students  Middle school: 57 schools/797 students

 Elementary school: 226 schools/2,626 students Scholarship Total – NT$5.86MM

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Hope After-school Class

Sunflower Wednesdays

 Weekday afternoons  22 schools

 Every Wednesday afternoon  6 schools  300 students

  • 1,806 students

Scholarship Total – NT$1.75MM Scholarship Total – NT$400KK

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Other Sponsorships

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Meal-Assistance

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Charity

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 Sponsorship to 17 non-for In 2019, provided 6,000 meals to profit organization for cultural students during winter and summer and educational advancement vacation.

Assisted Total – NT$360KK

 SCP Children’s Drawing Competition  SCP National Table Tennis Competition Prize Total – NT$1.6MM

Grant Total – NT$950KK

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Awarded Corporate Citizen Prize by Common Health Magazine

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 Long-term attention to disadvantaged children in rural areas to enhance their learning and competitiveness  Co-development and promotion of Tainan's local products: Burdock & wolfberry tea from Jiangjun Dist. and orchid essence skin care products from Houbi Dist., etc.  Donation of alcohol for epidemic prevention  Employees participation in SCP National Table Tennis Competition and Children’s Drawing Competition

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The First Senior Gym in Taiwan – Athletic Training and Health Center

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  • In 2020, 3 new athletic training & health centers and 8 service spots were established in various districts of Tainan City, with a total of 26,016 user times.

  • On average, each user increased his/her grip strength by 11.2%, sitting and standing by 10.4%, and walking speed by 5.5%. Using the Center is a safer and efficient way improve the muscle endurance of elderly people and to prevent sarcopenia.

  • Seven health seminars will be held in the second half of the year to promote sport and life care concepts.

  • Aerobic and yoga classes will be added to enrich exercise course selection.

40

Free Bone Mass Measurement and Community Health Seminar

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 Cooperate with medical institution, local community, and pharmacy for free bone mass measurement activity. In the first half of the year 2020, the activity was postponed due to the coronavirus epidemic. The second half of the year, a total of 4 sessions have been held so far. A total of 500 people were measured

  • 4 sessions of community health seminars have been held, with a total of 660 participants.

41

Q & A

42

Thanks for your attention

43