Mycenax Biotech Inc. (MBI) 永昕生物醫藥股Mycenax Introduction Biologics market trend Mycenax...

2017Mycenax Biotech Inc. (MBI)

永昕生物醫藥(股)公司

總經理温國蘭 Karen Wen, Ph.D.Nov. 16, 2017

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COPYRIGHT © MYCENAX BIOTECH INC.2

公司基本介紹生物藥品市場概況永昕策略方向

Mycenax Introduction Biologics market trend Mycenax Strategy

大綱 AGENDA




大綱 AGENDA

位置 Location

歷史與組成 Status

公司成立 ESTABLISHED: 2001

董事長 CHAIRMAN: 陳德禮醫師/教授/博士

總經理 PRESIDENT:温國蘭 Karen WEN, Ph.D.

員工 EMPLOYEES: 128 (82% in R&D and GMP

Manufacturing)

主要商業活動 Business Activities

生物藥受託開發生產服務 CDMO SERVICE生物藥品開發 Biological product development

財務 Finances

實收資本額CAPITAL: 1,121,180,000 NTD9/30庫存現金 CASH POSITION: 6.38 億NTD

Mycenax, A Bio-CMC Specialized Company

公司介紹 CORPORATE INFORMATION

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Jhunan

Hsinchu

Taoyuan

新竹科學園區之竹南基地Jhunan Science Park

COPYRIGHT © MYCENAX BIOTECH INC.


公司介紹 CORPORATE INFORMATIONMycenax - A Bio-CMC Specialized Company

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專注於提供國際級生物藥CMC能量，擁有開發快速、物超所值、國際規格的生物藥開發及生產，提供受託服務及自我產品線開發。Offer cost-effective, fast speed and international quality complied CMC platform for CDMO service and in-house pipelines.

全線一次性製程設計，最大反應器設備2000L，擁有國際級PIC/S GMP廠房，符合ICH、歐盟、美國、日本規範。

Full line singe-use technology with up to 2000L scales; complied with PIC/S GMP standard, and implemented of ICH, EMA, FDA and PMDA guidance.

台灣PIC/S GMP認證，美國DMF註冊。

TFDA PIC/S GMP certified; USFDA Drug Master Fie (DMF) registered.

定位 Position 特色 Feature 品質認證 Quality

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美國FDA DMF 註冊DMF registered

FDA Type V

原料藥 cGMP 認證cGMP for DS

受託開發服務CDMO Service

美&中客戶 (from US, CN)

針劑廠升級DP Line Upgrade

第三產線3rd FacilityFor microbial

第一產線1st Facility

Disposable tech-nology applied

灌流式製程Perfusion culture model

無菌充填針劑cGMP 認證cGMP for DP

受託開發服務CDMO Service日本客戶 (JP)

第二產線2nd Facility

Fed Batch 製程 2000L SUB


歐洲客戶 (EU)

永昕里程碑 MILESTONES


PIC/S GMP certifiedPIC/S GMP 認證

TuNEX

澳洲公司合作(Collaborated with AU)

Continuous Processing

自有培養基完成In-house MBI medium

MBICHOLusiNEX

2007 KFDA臨床試驗Phase I/PK2007 TFDA臨床試驗Phase I/II2009 KFDA臨床試驗Phase III2012 TFDA臨床試驗Phase III2017 TFDA MA 2017 TGA/TFDA/MHRA臨床試驗 Phase I/PK

澳洲客戶 (AU)


2003 2004 2005 2006 2007 2013 2014 2015 2016 2017

能量介紹 - GMP 工廠 FACILITY OVERVIEW符合國際品質規格 Compliance to and implementation per ICH, EMA, FDA, and PMDA

1,500 m2產線 2

產線 3

產線 1

750 m2 750 m2

Mab Substance 60,000 g200L, 500L, 2000L SUB

年產量 Annual CapacityDrug Substance

Drug Substance年產量 Annual Capacity

Mab Substance 7,200 g50L x 4 SUB (Wave)

Drug Product100,000 vials (liquid) 64,000 vials (lyophilization) 80,000 prefilled syringes

Drug Substance50L, 500L SUB

細胞庫建置 Cell bank establishment ● ● ●上游產程開發 Upstream process ● ● ●下游產程開發 Downstream process ● ● ●無菌充填 Fill/Finishing ●

開發能力 Capabilities

產線2 1 3

Mammalian

MicrobialMammalian

7 COPYRIGHT © MYCENAX BIOTECH INC.

無菌充填線 DRUG PRODUCT PRODUCTION ASEPTIC FILL/FINISHING多種充填選擇可滿足需求 Fill/Finishing Services for various choices


2017 2018 Q2

Liquid Filling 1,500-5,000 Vials 5,000-10,000 Vials

Pre-filled Syringe 4,000 Syringes 5,000-10,000 Syringes

Lyophilized filling 3,200 Vials 3,500 Vials

Cartridge - 5,000-10,000 Cartridges

確效批量 Validated scale

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效力 Potency

Cell based bioactivity assay– Proliferation– CDC– cAMP– Cytotoxicity

• Neutralization assay• Binding assay

含量Content

UV absorbance ELISA BCA/Bradford/Lowry

assay

HPLC– Affinity– Reversephase

• Formulation content– Detergent– Preservative

藥典 Pharmacopeia

Sterility• Bioburden• Endotoxin• pH• Conductivity• Liquid Particulate matter

• TOC• Removable volume• Uniformity-WV• Watercontent• Osmolality

純度/不純度 Purities and Impurities

HPLC– Sizeexclusion– Reverse phase– Ion exchange– Hydrophobic

interaction• CE-SDS

• Process related impurity– Host cell protein– Host DNA– TritonX-100– Imidazole– Insulin– Protein Aresidue– Heparin residues

成分 Identity

• Peptide mapping• SDS-PAGE• WesternBlot• IEF/cIEF

蛋白質&單抗分析方法建立與確效PROTEIN/MAB ANALYTICAL METHOD DEVELOPMENT & VALIDATION

擁有豐富經驗的分析開發及品管團隊 An Experienced QC Team Dedicated to Develop and Optimize Analytical Methodologies

結構分析Structural

Characterization

• Identity by SDS-PAGE• Charge variants by IEF, cIEF, CZE• Size variants by SDS-PAGE, • Immunochemical properties by WB• Carbohydrate by monosaccharides

analysis and glycan analysis, • Amino acid composition analysis

• Oligermer, aggregate, fragment by CE-SDS, SEC, HIC, RPC

• Impurities with deamidation and oxidation by IEX, Peptide mapping, RPC, CZE• LC-MS for Full sequence, N-terminal

sequence, C-terminal sequence, PTM, glycosylation site, glycan structure, and Disulfide linkage

• Secondary and tertiary structure by CD and FT-IR

• Cell based bioactivity assay– Proliferation– CDC– cAMP– Cytotoxicity

• Neutralization assay• Binding assay

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生物活性Bioactivity

純度/不純物Purity/ Impurities

TAF 認證蛋白質特性分析實驗室 Comprehensive Tests for Protein Characterization by In-House ISO17025 Accredited Lab

理化及免疫特性Physicochemical &

Immunological Properties

蛋白質&單抗特性分析 PROTEIN & MONOCLONAL CHARACTERIZATION


產程技術平台 TECHNOLOGY PLATFORM IN PROCESS DEVELOPMENT

MBIFast

Platform

MBI JUMP

Platform

Formulation

Development

MBICHO

MediumFull-Line

Continuous Processing

In-House 核心技術 Mycenax In-House Core Competency: Various Platforms To Satisfy All Kinds Of Needs

From DNA to cGMPmanufacturing in

18 months

Able to directly scale up from 5L scale

Experienced formulation development with profound

formulation database

Easy to control and optimize medium

Greater quality and efficiency via continuous product in and out

單株抗體快速開發平台

產程放大模組平台

劑型配方開發平台

自有培養基全線連續式製程

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產程開發Process

Development

全方位生物藥品開發服務 TOTAL SOLUTION FOR DRUG DEVELOPMENT

提供一站式完整的生物藥品開發 One-stop shop for protein drug development

專案管理 Project Management

✔︎ Cell line development✔︎ Upstream PD✔︎ Downstream PD

✔︎ QTPP and CQA set up✔︎ Protein characterization✔︎ Comparability study

✔︎Master/Working cell banking✔︎ Upstream mfg.✔︎ Downstream mfg.✔︎ QC/QA

✔︎ Vial Filling✔︎ Lyophilization✔︎ Prefilled Syringe

✔︎ CTD package (Module 3)✔︎ IND/NDA submission

特性分析Characterization

生產PIC/S GMP

manufacture

無菌充填Aseptic Fill/ Finish

法規送審RegulatoryCompliance

GMP





大綱 AGENDA

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全球十大藥品銷售 GLOBAL TOP 10 SALES DRUGS

十大藥品中有八個為生物藥品 8 Out of Top 10 Drugs Are Biological Products

autoimmunecancer

癌症免疫治療 (免疫檢測點)的浪潮 WAVE OF IMMUNO-CHECKPOINT THERAPY

• 四個產品上市4 launched: anti CTLA-4, anti PD-1, anti PD-L1

• 超過百個計畫在臨床階段More than 100 in clinical trials

• 更多實證經驗More understanding about the real world evidence for this therapy


• 藥品本質 Product Nature •蛋白質/融合蛋白質/單抗 Protein and its derivate/Fusion Protein/Mab•雙或多靶點 Bi or multiple specifics: Removab, Blincyto•單抗-藥品偶連物 Antibody drug conjugates (ADC): Mylotarg, Adcetris, Kadcyla,

Besponsa

•抗體-細胞結合物 Antibody cell conjugates•細胞及基因治療 Cell and gene therapies


生物藥品開發趨勢 BIOLOGICAL PRODUCT TREND


生物藥品開發趨勢 BIOLOGICAL PRODUCT TREND

使用途徑 Delivery system

Sandoz

Sandoz

Hexal

Medice

Stada

Hospira

Sandoz

Ratiopharm

Sandoz

Hexal

Hospira

Accord Healthcare

Apotex Europe

Lilly & BI

Samsung Bioepis & Merck

Teva Pharma.

Finox Biotech AG

Teva

Sandoz

2006 2007 2008 2009 2010 2013 2014 20172015

已上市的第一代生物相似藥 First Generation of Launched Biosimilars

Biopartners

從蛋白質開始 Biosimilar Development Strategy: Start from proteins (HGH, EPO, Filgrastim, FSH, insulin)

2013 2016 2017

Hospira

Celltrion Samsung Bioepis/Biogen

Samsung Bioepis/Biogen

BI


已上市的第二代生物相似藥 Second Generation of Launched Biosimilars

Celltrion

Hospira

Sandoz

Amgen

Amgen

Amgen


Pfizer

Amgen

最競爭戰場：銷售額前五大單抗及Fc 融合蛋白, 大廠參與


• 第一代生物相似藥:蛋白質已上市 First generation, protein, launched.

• 第二代生物相似藥: 單抗上市 Second generation, mAb, launched

• 生物相似藥之最重磅藥物也上市 Major Big 5 biosimilar launched

• 大藥廠領頭搶占生物相似藥領域 Big pharma in

• 新開發者的機會在第二波單抗生物相似藥 Opportunities in second wave of mAb

• 價格戰須先有準備 Pricing preparation

生物相似藥現況 SUMMARY OF BIOISIMILARS STATUS




大綱 AGENDA

永昕商業策略 HYBRID BUSINESS STRUCTURE

CMC技術平台TECHNOLOGY CMC-BASED PLATFORM

以CMC為基礎，穩固現金流，藉由合作投資開發，擴大版圖Deep CMC foundation for supporting and leveraging business capacity


單株抗體快速開發平台 MBIFast Platform

產程放大模組平台 MBI JUMP Platform

劑型配方開發平台 Formulation Development

自有培養基 MBICHO Medium

全線連續式製程 Full-line Continuous Processing

TuNEX (MA in TW 2017, ASEAN)LusiNEX (Ph I AUS 2017, GLOBAL PARTNERHIP)

自有產品 In-House Pipelines

Project 1: 2017 INDProject 2: 臨床三期 P3

轉投資 Investment

Project 1: 2017 臨床二期 P2Project 2: Pre-IND

委託開發服務 CDMO Services2017 至十月營收：2.4億新台幣 2017 2.4 E NTD till Sep.客戶：來自日澳美中台 Clients include JP, AUS, US, CN, TW


LusiNEX簡介 OVERVIEW OF LusiNEX

• 與第六介白素受體（IL-6R）結合

• 阻斷IL-6後，可達到抗發炎與調節免疫的效果，

減低關節損傷，改善病人的關節受損情況

• LusiNEX（Tocilizumab）：原廠參考藥物為Actemra®/ RoActemra®

• LusiNEX is Mycenax’s tocilizumab, a biosimilar version of

Actemra®/Roactemra®, is the humanized monoclonal antibody

IgG1 targeting interleukin-6 receptor (IL-6R). By binding IL-6R,

it blocks the inflammatory response and joint erosion.


LusiNEX開發策略 RATIONALE FOR THE DEVELOPMENT OF LusiNEX

• 第二代生物相似藥，市場份額大

Company Name Product Stage Product Geography

Fresenius Kabi/Merck Phase I (2017) Global

bioXPRESS Therapeutics SA Preclinical Global

Livzon Pharmaceutical Group IncPreclinical Global

Preclinical Global

Oncobiologics IncPreclinical Global

Preclinical Global

2016年Actemra®全球銷售約1.68億美元USD 1.68 billions for Actemra®/ RoActemra® in 2016

Global Data

•未來可望作為單劑治療，目前開發競爭對手少Increasing use as a single agent and less competition


LusiNEX開發時程 LusiNEX DEVELOPMENT TIMELINE

2016 2017 2018 2022 2023

Process & Analytical method development

Comparative PK study

Phase 3 study

BLA submission

Approved by EMA & FDA

2019

Multinational

AUS

GMP production (2000 L x 3 lots)

2015

Comparability study

QP Declaration Acknowledgment letter by TGA


• 上游產程 Upstream:產量 Productivity ≥ 3 g/L

• 下游產程 Downstream: 回收率 Recovery ≥ 80%, purity ≥ 99%

• 與原廠比較 : 高度相似

Highly similarity compared to RMP from US, EU and TW

LusiNEX 目前進度與策略 STATUS AND STRATEGY OF LusiNEX

Actemra

LusiNEX

Price Strategy< 10% of Originator

定價策略

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選題

法規及臨床

資金

資金

委託開發製造

永昕新藥開發模式：策略夥伴 MYCENAX NEW DRUGS BUSINESS STRETAGY

Deep CMC foundation for supporting and leveraging business capacity

永昕新藥開發部門

新藥專案管理公司

博晟(7.4%)昱厚(7.7%)

博晟生醫簡介 BioGend Theropeutics OVERVIEW

• 20160707成立；實收資本 5.57億 NTD

• 董事長：陳德禮

• 執行長：林滄城

• 總經理：陳德禮

• 主要股東：玉晟、元大、美國Exactech

• 永昕持股比例： 7.4%

主力產品 (1): 2017 Q4 IND 送件骨修復填充物 OIF/β-TCP

主力產品 (2): 臨床三期執行中自體軟骨修復技術 Biphasic Cartilage Repair Implant (BiCRI)

OIF in β-TCP

Non-weight-bearing site of Knee

Injecting cartilage chips into biphasic scaffold

Mincing cartilage to small pieces

Enzyme digestion

Biphasic scaffold

昱厚生技簡介 ADVA gene OVERVIEW

• 2013成立；實收資本 3.23 億 NTD

• 董事長：陳璧榮

• 總經理：徐悠深

• 主要股東：台灣光罩、元大、中加

• 永昕持股比例： 7.74%

主力產品 (1):鼻噴流感疫苗: Phase II

主力產品 (2):呼吸道過敏氣喘疫苗 Phase I in 2018

2013年(IPO)

0.64億元

2014年

1.13億元

2015年

1.35億元

2016年

2億元

2017年

前三季

2.25億元

2018年

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永昕近五年營業收入 MYCENAX REVENUES 2013-2017

目標

2018 永昕商業策略 2018 BUSINESS STRUCTURE以CMC為基礎，穩固現金流，藉由合作投資開發，擴大版圖Deep CMC foundation for supporting and leveraging business capacity


單株抗體快速開發平台 MBIFast Platform

產程放大模組平台 MBI JUMP Platform

劑型配方開發平台 Formulation Development

自有培養基 MBICHO Medium

全線連續式製程 Full-line Continuous Processing

TuNEX , LusiNEX

自有產品 In-House Pipelines

轉投資 Investment

委託開發服務 CDMO Services抗體藥物複合體 ADC Services

CMC技術平台TECHNOLOGY CMC-BASED PLATFORM

抗體細胞複合體 ACC Services雙或多特異性抗體 Bi or multi specifics

[email protected]@mycenax.com.tw

Thank you for your attention!!

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Mycenax Biotech Inc. (MBI) 永昕生物醫藥股Mycenax Introduction Biologics market trend Mycenax...

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Transcript of Mycenax Biotech Inc. (MBI) 永昕生物醫藥股Mycenax Introduction Biologics market trend Mycenax...

Mycenax Biotech Inc. (MBI) 永昕生物醫藥 股Mycenax Introduction Biologics market trend Mycenax...

Documents

Transcript of Mycenax Biotech Inc. (MBI) 永昕生物醫藥 股Mycenax Introduction Biologics market trend Mycenax...

Mycenax Biotech Inc. (MBI) 永昕生物醫藥股Mycenax Introduction Biologics market trend Mycenax...

Transcript of Mycenax Biotech Inc. (MBI) 永昕生物醫藥股Mycenax Introduction Biologics market trend Mycenax...