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SCI Investor Presentation 2019

Sep 12, 2019

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公司概況Profile

0084_68

員工數Employee:263
設立日期:中華民國七十六年九月十八日
Date of establishment: Sep. 18, 1987
資本額Capital:新台幣795佰萬元(NTD 795mn)
營業項目Business:
原料藥API(66.06%)
中間體Intermediate(25.29%)
特用化學品 Custom-made chemicals(8.65%)

Notes:

a production line dedicated

製藥產業的上、中、下游 SCI’s position
基本原料 RM
上游Upstream

中間體Intermediate:
生產原料藥之
中間步驟所產出之產品Products before API

旭富營業範圍
SCI’s businesses

中游
Midstream
原料藥API:
製劑中之有效成分Curative ingredient

下游
Downstream
製劑: 成品藥 Formulation

Notes:

emulsifier, excipient

公司概況 Outline

Notes:

營運概況-IS
Unit: K NTD

Notes:

lackluster October sales

產品組合-Products

Notes:

產品組合-Products

Notes:

2019 重點產品說明 Product Profile

VA / DiVANa / NaVA
(S)-MMAA / Duloxetine HCl
PGA
Hydroxychloroquine Sulfate
Menthadienol / Olivetol / Ethyl Olivetolate
HDFN / Prop-3 / Propafenone HCl
CBD
LMTM
Ritalinic acid / Methylphenidate
d-Ritalinic acid / Dexmethylphenidate

Notes:

VA Series:
Valproic Acid, Divalproex Sodium, Sodium Valproate

適應症 Application:
癲癇(seizure)、躁鬱症(bipolar disorder)、
偏頭痛(migraine headaches)

Sales up

Notes:

Half of sales from DIVA

S-MMAA / Duloxetine HCl
適應症 Application:
重鬱症(major depressive disorder)、廣泛性焦慮症(generalized anxiety disorder) 、糖尿病週邊神經痛
(diabetic neuropathy) 、纖維肌痛(Fibromyalgia)、
慢性腰痛(日本地區) lower back pain (only in Japan)

Sales up

Notes:

4 billion

Pyrogallolaldehyde ( PGA)
Benserazide
治療帕金森氏症之中間體
Intermediate for Parkinson’s Disease

Sales up

Notes:

249 million

Hydroxychloroquine sulfate
適應症 Application:
類風濕性關節炎(rheumatoid arthritis) 、瘧疾 (malaria)、
慢性多形性日光疹、慢性圓板狀紅斑症 (discoid and systemic lupus erythematosus)

Notes:

Menthadienol, Olivetol, Ethyl Olivetolate
為Dronabinol (THC 四氫大麻酚)及Cannabidiol
(CBD大麻二酚) 之關鍵中間體
The key intermediates for Dronabinol (THC) and
Cannabidiol (CBD)
THC 適應症 Applications:
化療引起的噁心、嘔吐
Nausea and vomiting due to chemotherapy
愛滋病引起之厭食症 anorexia due to AIDS
CBD 適應症 Applications:
Epidiolex:兒童罕見癲癇以及多發性硬化症
For seizures in patients aged 2 years and older, and Multiple Sclerosis.
多項臨床試驗進行中 More clinical trials are in progress

Notes:

CBD (Cannabidiol)
CBD之應用廣泛:從癲癇、巴金森氏症、阿茲海默症,到關節炎、躁鬱 、焦慮、失眠、止痛、抗發炎等。
市場規模:
CBD in US market: USD 20 billions in 2020 ?
Total Cannabi Opportunity: ~ 200 billions ???

旭富 CBD (Cannabidiol)
製程開發完成,準備專利申請,
2019年底申請製藥許可證
2020年初申請美國藥證 (US DMF)

CBD (Cannabidiol)
Wide range of medical benefits, from epilepsy, Parkinson’s and Alzheimer’s disease, bipolar disorder, anxiety, pain, inflammation, to arthritis, insomnia, etc.
Market estimations:
USD 20 billions in 2020?
Total Cannabi Opportunity: ~ 200 billions ???
CBD (Cannabidiol) by SCI
Process development completed, patent to be filed
To apply domestic license with TFDA by end of 2019
To file US DMF by beginning of 2020

LMTM 新藥代工 (1)

適應症 Application:
阿茲海默症(Alzheimer`s Disease):臨床3期進行中。
額顳葉型失智症(Frontotemporal lobe degeneration, FTD): 2018年底,已被美國FDA與EU核准為孤兒藥。
疾病現況
全球約有4~5千萬病人,隨著醫療的進步及人口老化,病人數持續增加。
目前並無可以停止或逆轉病程的藥,市面上的藥均只能短期緩解症狀。

LMTM 新藥代工 (2)

Application:
Alzheimer`s Disease: under phase 3 clinical trial
Frontotemporal lobe degeneration (FTD): granted by EU and FDA as Orphan Drug Designation in end of 2018.

Status:
There are approximately 40-50 millions patients worldwide, and is increasing.
While there is no cure for Alzheimer's disease, stopping or slowing down its progression, but just a temporarily improvement on certain symptoms.

Ritalinic acid / Methylphenidate (MEPH)?d-Ritalinic acid / Dexmethylphenidate (dex-MEPH)

適應症 Application:
注意力不足 (attention deficit hyperactivity disorder (ADHD) 、過動症 (narcolepsy)
MEPH 製劑需求量 (FDF consumption):
38.8MT, US$ 29.3億 (3/31/2018~3/31/2019)。
Dex-MEPH製劑需求量 (FDF consumption):
2.4MT, US$ 6.3億 (3/31/2018~3/31/2019) 。

新市場 (New Market):

與印度、中國 、俄羅斯及新興國家之合作
Partner with India, China, Russia and Emerging countries
新藥方向 (New drugs):
大麻二酚 (CBD)
中樞神經用藥 (CNS)
失智症 (dementia)
傷口癒合 (wound healing) / 抗衰老藥物 (anti-aging)
管制藥 (controlled substance)

No. API DMF (USA) CEP (EDQM) MF (Japan) DMF (Canada) CGMP certified (TFDA)
1 Valproic Acid 2003 2004 2008 2008 2003
2 Probucol 2004 2017 2015 2015
3 Divalproex Sodium 2005 2010 2005
4 Propafenone Hydrochloride 2010 2012 2012 2012 2010
5 Duloxetine Hydrochloride 2011 2014 2017 2016 2012
6 Allopurinol 2011 2003 2004
7 Clindamycin Palmitate HCl 2011
8 Articaine Hydrochloride 2014 2014 2013
9 Hydroxychloroquine Sulfate 2014 2014 2014
10 Brinzolamide 2015 2017 2015
11 Sodium Valproate 2006 2017 2004
12 Pentobarbital Sodium 2011 2009
13 Methylphenidate HCl 2014 2011
14 Bisoprolol Fumarate 2006
15 Thiopental acid 2012
16 Loxoprofen Sodium Hydrate 2011 2012
17 Atomoxetine HCl 2016

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