Good news for MM and MCL patients in China!
On November 30th, the approval document of Hansoh Pharma’s new anti-tumor drug Xintai (bortezomib for injection) was sent to Jiangsu FDA. According to a reliable source, this blockbuster drug has formally obtained CFDA-issued production license. The drug will be used in treatment of multiple myeloma (MM) and mantle cell lymphoma (MCL), which means China now has its own version of bortezomib, the great anti-tumor drug!
MM: The second most common malignant tumor of hematologic system
In an increasingly faster-paced society, human health is threatened by various diseases of which cancer tops the list. Cancer mortality rises every year along with the number of cancer types. Drugs for cancer inhibition and treatment are always in short supply.
According to Hansoh’s oncology drug R&D experts, multiple myeloma (MM), a member of the family of malignant diseases, is the second most prevalent blood cancer. MM cancerous cell originates from plasma cell in bone marrow (B lymphocytes develop to the final functional stage). MM is considered rare and incurable. In the United States, there are currently about 95,000 cases, with an estimation of 30,000 new cases and 12,000 deaths per year. In Europe, there are about 39,000 new cases and 24,000 deaths per year. (Source: Yaozh.com)
Xintai: The Killer of MM
Amongst the drugs currently available to treat MM, bortezomib is a blockbuster. In May 2003 it was approved by FDA as a treatment for relapsed and refractory MM, and allowed to be marketed in Britain May 2004 and then in China September 2005. Bortezomib’s ubiquitin–proteasome pathway mechanism won the 2004 Nobel Prize in Chemistry and the 2006 Prix Galien award, the most prestigious honor in the pharmaceutical industry.
According to Xintai’s R&D team, bortezomib is an innovative oncologydrug and a revolutionary breakthrough for the treatment of MM by specifically inhibiting the proteasome complex and blocking the transduction of tumor-promoting signals.
Before the invention of bortezomib, MM was a nightmare for its victims. Multiple studies abroad have shown that the response rate of bortezomib-based therapies in treating MM was 78% to 100%, making it the first choice. “Clinical studies have demonstrated that bortezomib significantly improved treatment effects on patients with MM, increased the remission rate and also prolonged survival, thus being recommended as the first-line treatment for multiple myeloma by domestic and foreign guidelines”, remarked by Xintai’s R&D team.
In addition, it’s also indicated that bortezomib is effective in treating patients with lapsed/refractory mantle cell lymphoma, and recommended to be used in treating T cell lymphoma and other refractory tumors by foreign guidelines.
It has been a long-standing issue that the proportion of patients with MM that receive proper treatment in China is relatively low due to the high price of original drugs.
With “serve the society and build a healthy world” as our mission, Hansoh Pharma is determined to increase drug accessibility for Chinese patients. The Xintai (injectable bortezomib) R&D project was initiated in 2009. Xintai’s R&D team said: “NDAfor Xintai was submitted in October 2012 and accepted by CDE in December of the same year. Due to its significant potential social benefits, its review was prioritized in October 2016 (as shown in Table 1). The “Three-in-One Review” was completed on September 5 2017 (as shown in Table 2). The “Mailing List of Drug Approval Packages” published by CFDA on November 30 confirmed that Xintai officially obtained the registration approval. The launch of Xintai will provide better treatment and premium drugs with great efficacy and quality for Chinese patients with MM or MCL, bringing health and wellness to Chinese people, which is also Hansoh’s primary goal”.
Xintai is expected to be launched within this year. As pointed out by the news release of Yaozh.com titled “Exclusive: The First Generic of Blockbuster Drug Bortezomib Might be Launched Soon”, this is a great news for all Chinese patients with MM or MCL.
