Weekly Roundup

AstraZeneca VP talks off-patent strategy; Denovo picks up global rights to Lilly lymphoma candidate

23 September 2014

AstraZeneca Vice-President Wang Lei offered his views on the growing challenges facing MNCs' off-patent brands in China. Noting the closing quality gap between branded generics and local versions, Wang points to the need to build physician and patient trust and brand equity as the key currency for MNCs going forwards, citing the example of Merck Sharp & Dohme's Zocor (simvastatin) as an example of a drug that tried to compete on price with local firms with little success.

Volume 72 of the CPB Review looked at AstraZeneca's decision to shift resources away from branded generics towards innovative products in light of growing pricing pressures. GBI SOURCE users will find the article in the Special Reports section


SOURCE Snapshot

Zhejiang Huahai last week gained approval from the China Food and Drug Administration (CFDA) to begin clinical trials of rivastigmine, an acetylcholinesterase inhibitor used to treat senile dementia. Roche's originator drug Exelon is currently the only version of rivastigmine approved in the Chinese market. This week's SOURCE Snapshot looks at the rest of Zhejiang Huahai's R&D pipeline.

Company News

There was a buzz of company news last week, with domestic-based firms prominent:

  • China-based Denovo Biopharma last week scooped up global rights to enzastaurin from Eli Lilly; the candidate failed to reach Phase III endpoints in diffuse large B-cell lymphoma, but Denovo will take on development by singling out a subset of patients that did show improved progression-free survival in that trial, and intends to conduct genetic analysis to identify relevant biomarkers
  • Milestone Scientific formed a joint venture with Milestone China on development of a painless botox injection system
  • BeiGene picked up another USD 9-million milestone payment from Merck Serono as their collaboration on development of PARP inhibitor BGB-290 progressed further into Phase I
  • CASI Pharma picked up China development rights to three drugs from Spectrum: oncology drugs Zevalin (ibritumomab tiuxetan) and Marqibo (vincristine sulfate liposome), and a Phase III candidate, captisol-enabled melphalan
  • Hualan Bio filed an investigational new drug application for a biosimilar of Herceptin (trastuzumab)
  • And 3SBio will take on China development of compatriot firm JenKem Technology's PEG-irinotecan, a long-acting version of Pfizer's Camptosar


Regulatory Developments

On the regulatory side: the Chinese government's spate of anti-monopoly investigations into foreign firms, which have included significant focus on the pharma and med device industries, came under fire from the U.S. Treasury Secretary Jacob Lew as a source of potential friction between the two countries; the State Council held a meeting on health reforms, with the tendering system reportedly facing "major changes" imminently, and drug registration pathways also set for adjustment; Sichuan revealed plans for a cross-province network to better coordinate patient management and resources between hospitals and primary clinics, with telemedicine capabilities to form a support for the roll-out; Ningbo revealed plans to establish China's first cloud-based hospital, which will draw physicians from five municipal hospitals to provide online health advice in relation to diabetes, as well as online drug prescribing; finally Zhejiang released its central drug procurement guidelines for this year, and also unveiled a novel points system to discourage unnecessary or over-expensive prescribing by physicians - physicians repeatedly found to be stepping beyond prescription guidelines face being barred from treating medical insurance participants.



The Ministry of Science and Technology (MOST) last week initiated a major project led by the Chinese Academy of Medical Sciences (CAS) Cancer Institute to revise the Chinese cancer atlas, aiming to establish a regional database covering cancer prevalence information in each county, as well as reflecting changes in cancer mortality rates since the last version was produced 40 years ago.

Volume 17 of the CPB Review takes an in-depth look at the cancer drug industry in China, including the domestics-dominated field of cytotoxics and the opportunities for targeted therapies. GBI SOURCE users will find the article in the Special Reports section.


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