7. 新藥的商業特性
• High risk and high returns
• Initial capital requirements may be small
• A good project can induce corperate partnership
at an early stage
• The license right and IP of key product
candidates is the core value of a young biotech
company
8. 抗體藥物提供主要的動能
Reasons:
• Advances in antibody engineering technology
• High specificity
• Very stable
• Superior pharmacokinetic properties
• Manufacturing process generally well established
9. 先進的抗體工程科技
Some important developments:
• Humanization and affinity enhancement
• Various anitbody libraries for display and
screening
• Single B cell PCR of VH and VL
• Various ways to make human monoclonal
antibodies
• Bispecific antibodies; asymmetrical antibodies
• High expression of antibody genes in CHO cells
10. scFv:抗體工程非常有用的基礎
• For constructing various libraries for display and
screening
• For screening antigen-specific antibody clones
• For performance antibody humanization and
affinity enhancement
• For constructing antibody drugs of various new
configurations(single chain antibody, scFv)
19. 抗體藥物靶標的一般特徵
• In most case, they are proteins.
• Receptors or ligands on cell surface of specific types of
cells, e.g. tumor cells of specific tissue origins, leukocyte
subsets, or specific tissues, etc.
• Functional mediators present in extracellular space or
blood, r.g. cytokines, chemokines, IgE, factors involved
in blood clotting, etc.
• Envelope proteins of certain viruses
20. 臨床驗證的抗體藥物靶標
• 在腫瘤學中 – CD20, CD19, CD4, CD33, CD38, CD52,
EGFR, HER-2/neu, VEGF, VEGFR, CTLA-4, PD-1, PD-L1,
RANKL, etc.
• 在自身免疫性疾病中– TNF-α, CD20, IL-1, IL-5, IL-6,
IL-6R, IL-13, IL-17, IL-17R, α-4 integrin, BAFF, etc.
• 在哮喘，過敏，慢性蕁麻疹– IgE, IL-5, IL4/IL13R,
etc.
• 感染性疾病 – RSV-F protein, etc.
• 用於器官移植，骨質疏鬆症，低密度脂蛋白
膽固醇，血友病等, etc. – CD3, RANKL, PCSK9,
Factor IX, Factor X, etc.
21. 創新Innovation vs. 前瞻forward-looking
• Technological innovation breaks apart the prior art.
• Innovation/novelty is the basis of patentability.
• Forward-looking represents a positive view on a
new development; it is not an invention.
• Often, when a governing body express a forward-
looking view on a field, major inventions in the
field are already made.
• Many projects are forward-looking, but lack
novelty.
22. 標的與選題
Personal view:
• It should be pursued by individual investigatiors,
who have the strongest interest and the best
insignt in their fields.
• Governmental or instututional selections may
emphasize more forward-looking than innovation.
• Government should nurture stimulating
environment.
23. 如何找到發展抗體藥物的機會
You need a team with:
• Updated knowledge on therapeutic antibody field
• Expertise in antibody engineering
• In-depth knowledge on the intended target
disease
• Capability to evaluate ideas, proposals, or
existing technologies/product candidates.
24. 如何找到好的新藥候選名單
Criteria:
• Expected patent position is very strong
• First in class
• Anticipated pharmacology is convincing
• Product manufacture is feasible
• Addressing a major medical need
26. 新藥探索及選拔階段
• The average cost establishing a new drug
candidate is very high- $674M
• The cost for different product candidates
vary greatly.
• A research group can create a very large
value if it generate a high quality product
candidate at a low cost.
• The ability to develop product candidates
is the biggest variable in building a
biotech company.
