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License-In / Co-Development Opportunities for China

The 13 Drugs Approved by FDA in 2013 (Till June)

Report Overview

The pharmaceutical industry is facing challenges,

Expiration of top selling products: e.g. Cymbalta, Avonex, Humalog, Xeloda, etc.
High R & D expenditure of about 60 Bio.USD during the past three years.
Stricter FDA approval requirements with more supporting data.
More price controlling as result of the implemented China Medical Reform System especially for patent expired products responsible for a major part of revenues of most pharmaceutical MNCs in China.

Therefore, having innovative products with sufficient price protection is of key importance for winning with sustainable growth in the foreseeable future.


FDA has approved 26 new products in 2009, 21 new products in 2010, 35 new products in 2011 and 39 new products in 2012.


Based on Loudon’s in-house database, we selected the 26 most likely to be approved products, which would benefit both to MNCs and local companies in China from following perspectives:

MNCs will have opportunities to license in or obtain sales rights in China, if the products are relisted, and when the company has a presence in China.
Local companies will have license-in or co-development opportunities after having conducted the necessary patent checks.They may have chances to start first the development of a generic copy in China, then globally.

This report describes information of each product, including their regulatory status, and their companies’ status in the China market. Moreover this report enables the readers to get an in depth understanding of the generics of those 13 products in China, thereby obtaining a comprehensive view for business decisions. Furthermore, this report analyzes the license-in opportunities based on each product’s characteristics.


Key Report Features

Report contains 13 products approved by FDA in 2013 (till June) in the following therapeutic areas:

Endocrinology 2
Diagnostic drug 2
Genetic Disease 1
Immunology 1
Hematology (cancer) 1
Respiratory 1
Obstetrics and gynecology 2
Oncology 3

For each molecule, both product and company related information are presented to help companies to identify business development opportunities.


Product related information:

The brand, chemical names and company
Therapeutic area, mode of action, indication and formulation
Regulatory status FDA, EMEA, and China (SFDA)
Medical information and framework of pivotal clinical studies

Company related information:

Contact information
R & D platform
Other products in portfolio & pipeline
China presence.

The report contains 36 pages and is in Chinese presentation format. English version will be charged additionally.


Who Would Benefit From This Report?

CEO and CMO (Chief Marketing Officer)
Marketing Directors/ Product Managers
Business Development Director/Managers
Medical Directors
Director Regulatory Affairs
Researchers and financial analysts in life science industry
Private and institutional investors in life science industry
Research institute

Publication date

Sep 26, 2013


Price

5,000 RMB or 800 USD per subscription.




*You can send E-mailEmail to LFE to purchase this report.


Please transfer the RMB or USD payments to the following account:

 

A/C: Shanghai Loudon Marketing Consultant Co., Ltd
A/C: No. 444259223258
Bank Name: Bank of China Shanghai, FanYu Road Sub-branch
Swift code: BKCHCNBJ300

 

Name Beneficiary：Loudon Far East B.V. The Netherlands
Bank Name：ING Bank N.V.
Account No：67.38.48.906
IBAN：NL23INGB 0673848906
BIC/SWIFT：INGBNL2A

 

 

 



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