Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Another reason CASI SP may have went up is a change in China's regulatory environment. From Bloomberg - Big Pharma Gets Boost as China Speeds Up New Drug Approvals Bloomberg News ?October? ?8?, ?2017

https://www.bloomberg.com/news/articles/2017-10-09/china-launches-overhaul-of-drug-approval-in-win-for-big-pharma

Some excerpts

• Overseas clinical trials will be accepted, Xinhua reports
• Changes will likely shorten delays in access to new treatments

...Under China’s new rules, data from overseas clinical trials can be used for drug registrations in the country. That removes the need for manufacturers to conduct added tests in China after receiving overseas approvals and will likely cut delays in the launch of new drugs by several years.

...“For multinational and leading local innovative drugmakers, the anticipated acceleration of approval will improve patients’ access to new medicine and increase revenues for pharmaceutical companies,” said Jialin Zhang, senior health-care analyst at ICBC International Research Ltd. Foreign manufacturers control about a quarter of the Chinese pharma market, with the rest held by local players, he estimates.

...In the short term, foreign drugmakers might be the prime beneficiaries because they’re already starting to see quicker approvals for their drugs and have deep pipelines of medicines in development, Zhang said.

...The changes announced Sunday had already been widely telegraphed by the Chinese government, which earlier this year said it was considering overhauling the approval process.

So when CASI indicated in their latest PR that

EVOMELA®:
China's Food and Drug Administration (CFDA) has granted priority review for CASI's import drug registration clinical trial application for EVOMELA (melphalan) for Injection. The CFDA cited the following three reasons for granting the priority review:
1. EVOMELA is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
2. There is no melphalan in any formulation available in China to address this unmet medical need;
3. EVOMELA has clear therapeutic advantages to currently available therapeutics.
MARQIBO® and ZEVALIN®
The CFDA review of CASI's MARQIBO import drug clinical trial application (CTA) is in process. The Company anticipates that the CFDA will complete its review of the CTA in the next four to six months, and expects to initiate the confirmatory trial within six months after CTA approval. The confirmatory trial is required as part of the registration process for the import drug registration.
The CFDA filing and review of CASI's ZEVALIN import drug clinical trial application (CTA) is in process. The ZEVALIN antibody kit and the radioactive Yttrium-90 component of the clinical trial application require separate submissions to the CFDA, which the first part is currently under review and the latter part is in the submission process. The Company expects to initiate the confirmatory trial within six months after the CFDA's approval of both the ZEVALIN kit and the Yttrium-90 submissions.
Ken Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are pleased that the CFDA in granting priority review for EVOMELA has recognized the superior therapeutic advantages of EVOMELA to address the urgent unmet medical need in the rare disease of multiple myeloma in China. Melphalan is extensively used worldwide in the treatment of patients with multiple myeloma, however, no formulation of melphalan is currently available in China. We appreciate the CFDA opening this accelerated pathway for this critical medicine to reach patients in China; it also is a positive signal from the CFDA to accelerate the import drug registration process for U.S. FDA approved drugs in order to address the significant unmet medical needs of the Chinese population in an accelerated time frame. We also are pleased with the progress of MARQIBO and ZEVALIN and are looking forward to their continued advancement in the import drug registration process."

is more significant than when I first read the PR. Here's the link to CASIs PR

http://www.prnewswire.com/news-releases/casi-provides-pipeline-development-update-300515388.html