YICHANG HUMANWELL

PHARMACEUTICAL CO., LTD.

1. Introduction to Humanwell Healthcare Group
2. Introduction to Yichang Humanwell
Pharmaceutical
3. Acdamic Activity
4. Our Strengths
5. Strategic Cooperation
1. Introduction to Humanwell Healthcare Group
1. Introduction to Humanwell Healthcare Group

vFounded in 1993 in China

vCompany headquarters are located in Bio-lake, the third
largest high-tech development zone dedicated to healthcare
in China
vListed on the Shanghai Stock Exchange since 1997
(600079.SH)
vStrong presences in Asia, North America, Europe and Africa,
with significant day-to-day operations in more than 15, and
products sold to more than 150 countries
Integrated Business

² Pharmaceuticals ² Direct Sales Force: 5,000+

² Biotechnology ² Vast Distribution
² TMCs Network
² Devices ² Direct Access: 10,000+
² Diagnostics Hospitals
² Consumer Healthcare Quality Market ² Pharmacy Coverage:
Products Reach 30,000+

Hospitals
² Central and Global R&D ² Serve Millions via 16
R&D Centers
& Clinics General, Specialty, and
² Balanced Pipeline TCM hospitals
² Domestic and ² Wuhan’s Largest Medical
International Web-portal
Collaborations
Business Highlights

vNumber One Provider of Anesthetics and Analgesics

vDirect Access to 10,000+ Hospitals in China
vNumber One Soft-gel Manufacturer in China
v400+ Products Marketed in China and Globally
vTop Three Provider of Fertility Regulation Drugs in
China
v20+ Manufacturing Plants in the World; Two in the
US and Two in China with FDA Approvals
vNumber One Provider of Uyghur Medicine
v13,000+ Employees Worldwide
vPharmacy Coverage: 30,000+
Market Leader of Anesthetics & Analgesics

v2019 Expected Total Sales of Anesthetics and

Analgesics of $500 Million

v60% Share of the Chinese Market

vEleven Products Manufactured and Sold in China

and Asia, the Most of Any Company

vSingle Source of Five Products

vEighty Drug Candidates in Clinical Development

vEight NCEs in Pre- and Clinical Trials

Extensive Chinese Sales and Distribution

vSales Professionals: 5,000+

vThirty Provinces and Districts with

Established Distribution Networks

vDirect Access to 10,000+ Hospitals

vCovered Pharmacies: 30,000+

vNumber One Distributor of Roche

Diagnostics in Beijing
Drug Pipeline
Select NCEs and Biologics Snapshot
Development Status
Name Description Indication
Phase I Phase II Phase III
Fospropofol
Prodrug of propofol Anesthesia
Disodium
Naked plasmid DNA expressing
Critical Limb
pUDK-HGF human hepatocyte growth
Ischemia (CLI)
factor
Adenovirus containing Ischemic Myocardial
ad-HGF
hepatocyte growth factor Infarction
Ultra-short-acting intravenous
Remimazolam Anesthesia
benzodiazepine
Morphine-6-glucuronide, a
M6G major active metabolite of Anesthesia
morphine
WB1-340 PARP inhibitor Cancer

HWH486 BTK inhibitor Rheumatoid Arthritis

S6 Non-Steroid Anti-Inflammatory Pain, Inflammation

A True Global Company

Country where Humanwell has manufacturing facilities and significant day-to-day

operations
Aiming to Be a Top Ten US Generics/Specialty Player

History
² Entered the US in 2008 with the establishment of
PuraCap Pharmaceuticals
² Acquired Epic Pharma, LLC in 2016
² Acquired the Ritedose Corporation in 2017 with
AGIC
Present
² Capabilities: Soft-gel manufacturing, controlled
substances, extended release, Blow-Fill-Seal (BFS)
² 30 marketed NDAs and ANDAs
² 20+ ANDAs pending FDA approval
² 50+ NDAs and ANDAs in development
² Expected 2017 combined sales of $300 million
Future
² Reach $1 billion sales through organic growth and
M&A
² Importation of US drugs and technologies to China
that enhance our US financial performance and
strengthen competitiveness in China
Humanwell: Your Partner in China and Worldwide

vA global company with major operations in Asia, America,

Europe, and Africa

vLarge footprint in two of the largest Pharma markets: US and

China

vGlobal R&D and manufacturing infrastructure facilitates both

technology transfers and product approvals

vExtensive sales and distribution network in China will expedite

market entry and penetration

vInvestor partnerships and deep capital access

2. Introduction to Yichang Humanwell Pharmaceutical
2. Introduction to Yichang Humanwell Pharmaceutical

Company History
Yichang Humanwell pharmaceutical Co.,
Ltd was established in August 8th ,2001.
Its predecessor, Hubei Yiyao Group was
a large comprehensive enterprise firstly
founded in 1954.
 C O M PA N Y P R O F I L E
Sales revenue（2018) 3.14
Domestic Narcotics
billion RMB Total employee 4700+
or 467million USD Market share 60%

Total asset 3.02 billion RMB

or 463 million USD Annual growth rate 21.3%
 C O M PA N Y P R O F I L E
Sales of Anesthetics drugs

Year Sales Revenue (in 100 millions RMB)

2014 17.3 (260 million USD)

2015 19.5 (293 million USD)
2016 22.34 (319 million USD)
2017 27 (414 million USD)
2018 31.42 (467million USD)
2019 41（612million USD)

In 2018, Sales revenue of anesthetics drugs occupies 80% of total company sales.
 • Plant Introduction

We are export drug manufacturing

base with That we are essential medicines
leading international standards , and manufacturing base with
set up international manufacturing international standards built a
system and management team, foundation for our rapid
which made us step on development on general drug area.
internationalization road.

Biological Industry Site Dongshan Site Yuan’an Site

We are first-rate anesthetic

researching and manufacturing
base. Which ensures our position
as “the leader
of anaesthesia and analgesia field”.
GEOGRAPHICAL POSITION

Yichang Humanwell Pharmaceutical

Yuan' an Industrial Park)
Yichang Humanwell Pharmaceutical
Dongshan Industrial Park

Exportation Base for Oral Solid

Dosage Forms
 YICHANG HUMANWELL
PHARMACEUTICAL CO.,LTD

• Organization Chart
Biological Industry Yuan’an Plant FSMP Outfast
Dongshan Plant
Plant Company

Outfast
Oral Solid Dosage Yuan’an Oral Dosage Manufacturing
API Plant Plant
Plant No.1 Plant

Raw Materials Yuan’an Oral Dosage

New API Plant
Plant(in process) No.2 Plant

Small dose Yuan’an Oral Dosage

injection Plant No.3 Plant

• Apart from three manufacturing sites, Lyophilized

Powder Yuan’an Small Dose
we also established an enterprise and Emulsion
Injection Plant

focusing on food for special medical Plant

purposes(FSMP).
Medical
Equipment Plant
 T H R E E I N D U S T R I A L PA R K S
1. Yichang Humanwell Pharmaceutical Dongshan
Industrial Park Capacity:
□ 600 million ampoules of small volume injection
□ 30 million vials of lyophilized powder for
injection
□ 1200kg max per year for Fentanyl citrate
dedicated production line
□ 80kg max per year for Sufentail citrate
Plant area: 38 acres
dedicated production line.
Products: Narcotic APIs and Finished Dosages □ 250kg max per year for Remifentanil HCl
dedicated production line
 D O N G S H A N I N D U S T R I A L PA R K
Company - Layout
Warehouse(FDF&API)
API Plant 7545m2
12176m2
Chemical Warehouse
1300 m2

4F
Quality Unit 4176 m2

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 T H R E E I N D U S T R I A L PA R K S
2. Yichang Humanwell Pharmaceutical Yuan' an Industrial Park

Capacity:
□ 2 billion pills of tablets;
□ 20 million bags of granules;
□ 200 million pills of capsules;

National GMP 2010 version

Plant area: 142 acres

Products: Drugs in National Essential Medicine List

In June 2019, Yuan`an Pharmaceutical Plant is to be inspected and certified by EU GMP. Since then,
products of Yuan`an Pharmaceutical Plant would be distributed to EU market, and Yuan`an Plant will be
able to undertake product processing orders from European customers.
 T H R E E I N D U S T R I A L PA R K S
3.Exportation Base for Oral Solid Dosage Forms
Capacity:
□ 5 billion tablets
□ CMO OTC products exporting to US&EU at
present

Approval by USA FDA with zero defect in June,

2016 and Jan, 2017.
OSD Plant area: 115 acres Approval by UK MHRA in April, 2018

Products: Oral Solid Dosage Forms

OSD is designed by CRB (US Engineering firm) and construction supervision by MWG Life Sciences (Germany Engineering firm) to comply with US FDA,
CFDA, and EMA regulatory requirements. Today in a tightly regulated environment, OSD manufacturing facilities has been inspected by US FDA with Zero
Observation twice in June, 2016 and January, 2017. What’s more, UK MHRA inspected OSD Plant from Feb.26th to Mar.1st 2018, and OSD has
successfully received the GMP certificate issued by MHRA on April.26 2018.
Dosage Forms Intrduction

Small dose Tablet lyophilized powder Hard capsule API

injection
World-class

11 production lines 4 production lines 2 production lines 3 production lines 9 production lines

Granules Syrup Soft capsule FSMP Medical

equipment
Domestic adv
anced level

3 production lines 2 production lines 1 production line 1 production line 1 production line
Implementation of Internationalization Strategy in Quality System

February, 2012-OSD foundation laying May 2016- EU on-site reception team January 2017- accept USA FDA on-site
ceremony inspection

June 2017-SME team was discussing the April 2018-initiate the meeting of Newly-
January 2018-competing for posts after the
organization structure of quality system built quality system Operation
Organizational structure optimization in QA
with the consultant experts
Department
International Certification of the Quality Management

Official Date of
No. Products Manufacturing Workshop
Organization Obtainment
Narcotic API workshop
7 EU EDQM API （Fentanyl Citrate） 2016.10.11
small-volume injection
small-volume injection、Lyophilized powder workshop
8 Uganda 2017.08.11
injections 、Lyophilization & Emulsion
Plant
Oral Metformin Hydrochloride Tablets Yichang Humanwell OSD Plant
9 USA FDA 2017.01.13
500mg, 850mg and1000mg

Oral Potassium chloride sustained-release tablets

10 USA FDA Yichang Humanwell OSD Plant 2017.03.08
8mEq（600mg）and 10Eq（750mg）

GMP Inspection(Tramadol Hydrochloride capsule

11 UK MHRA Yichang Humanwell OSD Plant 2018.04.10
50mg）

Oral Micron Hydrochloride sustained release capsule

12 USA FDA Yichang Humanwell OSD Plant 2018.06.25
7mg, 14mg, 21mg, 28mg

Yichang Humanwell Yuan'an

13 MHRA Paracetamol 500mg 2019.08.22
Pharmaceutical Plant 1
International Certfication of the Quality Management

Company Leaders Photographed With Colombian Company Leaders Photographed With Korean
Inspectors Inspectors

Company Leaders Photographed With USA FDA Company Leaders Photographed With EU
Inspectors Inspectors
International Certfication of the Quality Management

Passed the USA FDA On-site Inspection 2

Consecutive Times with Zero Defect

Passed the UK MHRA On-site Inspection

with High Levels
 Q U A L I T Y C E R T I F I C AT E

2016 2017
2012 2013
2007
The workshop for
2014 Remifentanil HCl API The small volume
MA for 10 MA　approval went through MFDS
2015 injection plant and
EDQM's Fentanyl (ten　countries) inspection smoothly in the lyophilized
COS approval　in April, 2016
Ethiopia、Kenya　 powder and emulsion
Certificate Vietnam ISO 14001
site inspection plant went through
for approval The workshop for
approval Uganda NDA
Fentanyl Fentanyl citrate API inspection smoothly
Citrate ISO18001 went through EDQM
13 MA　approval(７ in May, 2017
countries) approval inspection smoothly in
May, 2016 Obtaining GMP
certificate issued by
MHRA, EU in
August 2019.
G M P C E R T I F I C AT E
CFDA
C E R T I F I C AT E O F S U I TA B I L I T Y
FENTANYL
CITRATE
CEP
 MAIN PRODUCTS

Sufentanyl
Fentanyl Midazolam Flumazenil Alfentanil
Remifentanyl Citrate
Citrate Injecti Injection Injection HCL Injection
HCl Injection
on

Paracetamol Hydromorpho Dexmedetom

Pethidine HCl Ropivacaine Nalbuphine
&Tramadol ne HCl idine
Injection HCl Injection HCL Injection
HCl Tablet Injection HCl injection
 NEW DRUGS IN PIPELINE
Product Pre-clinical Phase 1 Phase 2 Phase 3

Fospropofol Disodium Lyophilized Powder Inj.

Buprenorphine HCL and Naloxone HCL Sublingual Tablet

Emulsified Isoflurane Inj. Yes

Oxycodone HCL and Ibuprofen Tablet Yes

Midazolam Oral Solution

Yes

Ibuprofen and Hydrocodone Bitartrate Tablet

Remimazolam Injection
 GLOBAL MARKETS featured product Rimifentanil
Fentanyl Citrate have successsfuly come into the
API inpected by Philippines market, which is a
Sale of Fentanyl EDQM, expecting new breakthrough of
Citrate API in Turkey to reveive EU anaesthetic in the Philippine
GMP in the end market
Sale of
Fentanyl of 2016.
Small Volume
Citrate API Sale of Sale of Injection plant &
in Fentanyl Remifentanil Lyophilized The technical transfer
Colombia, Citrate API In API in Brazil powder for cooperation of fentanyl in
Cuba. Egypt and injection and Indonesia realize the zero
Poland emulsion plant Remifentanil API breakthrough of China's export
obtain INVIMA inspected by of anaesthetic drugs
GMP certificate South Korea
Remifentanil
for MFDS, expecting
injection/Glicla to receive South
zide approval Korea GMP in the The workshop for Remifentanil
Sale of Sale of Sale of
Sufentanil in Hong Kong end of 2016. HCl API and Fentanyl citrate
Ciprofloxacin Remifentanil Fentanyl Inj In
Inj approval Sale of Fentanyl Inj. API went through Uganda NDA
Tab in Hong for injection Philippine
in Vietnam in Sri Lanka inspection smoothly
Kong in Chile

2010 2011 2012 2013 2014 2015 2016 2017

 BUSINESS DISTRIBUTION

Export to 25 countries
 DOMESTIC MARKET
Products Coverage rate in Anesthesiology dept
Top-class hospitals is 98.6%
Hospitals with annual operations exceeding 5000 is 98.8%

• Products are used in more than

18,000 hospitals, in which 1280
hospitals with annual
Sales Department
operational cases exceeding
Anesthesiology dept, 5000
Oncology dept, Pain • 31branch offices in whole
Management dept , country
ICU and • Over 2400 sales force till Aug
Pharmaceutical across every corner of China
preparation section
etc.
 ACADEMIC ACTIVITIES

Actively participate in Academic activities. such as CSA( annual meeting of Chinese society of anesthesiology）OCAP
（oriental congress of anesthesiology and preoperative medicine and etc.
 MARKET ACTIVITIES

Signing ceremony with Indonesian pharmaceutical - China's narcotic drug technology exports to achieve new
breakthrough
 MARKET ACTIVITIES

In April 27th 2017,our company’s featured product Rimifentanil have successsfuly come into the Philippines market,
which is a new breakthrough of anaesthetic in the Philippine market.
4. Our Strengths

• Solid production experience on different dosage forms, including tablets, capsules,

soft capsules, syrup, granules.
• International and domestic premium brand equipments, with stable and good
operation capacities, which are capable of producing different dosage forms.
• International and domestic premium brand public utilities with sound capabilities.
• Well equipped, and powerful QC center, which can monitor and control the
quality of product effectively.
5. Strategic Cooperation

• Paracetamol 500 mg Tablets

• CMO cooperation opportunity for Oral Solid Extended-release Dosage Form (FDA
approval), tablets & capsule (MHRA) and lyophilized products (CGMP application
in process)
• Chinese market chance
THANK YOU