Home > Active Ingredient News > Blood System > "Wan" is in the spotlight, "moving" road follows, domestic melphalon helps China's transplant field to flourish - Wanjia ® melphalon hydrochloride hydrochloride cloud summit forum for injection was successfully held!

"Wan" is in the spotlight, "moving" road follows, domestic melphalon helps China's transplant field to flourish - Wanjia ® melphalon hydrochloride hydrochloride cloud summit forum for injection was successfully held!

  • Last Update: 2023-02-03
  • Source: Internet
  • Author: User
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Wanjia ® (melphalan hydrochloride for injection) was approved on August 23, 2022 by the original drug Alkeran® (50mg lyophilized powder needle propylene glycol solubilization) as the standard copy, and its wide range of applications can be used for adult leukemia, malignant lymphoma, multiple myeloma (MM) and childhood leukemia, High-dose pretreatment before hematopoietic stem cell transplantation for solid tumors; It can also be used for palliative care
in patients with MM.


On December 31, 2022, the "Wanjia ® Mephalon Hydrochloride Hydrochloride Cloud Summit Forum" hosted by Xi'an Libang Pharmaceutical Co.
, Ltd.
was successfully held
online.
Professor Wu Depei of the First Affiliated Hospital of Soochow University, Professor Ma Jun of Harbin Institute of Hematology and Oncology, Professor Huang Xiaojun of Peking University Institute of Hematology and Professor Zhu Jun of Peking University Cancer Hospital were invited as chairpersons of the conference.
Professor Dong Yujun of Peking University First Hospital serves as the executive chairman
.
At the same time, well-known experts in the field were invited as speakers and discussants to discuss the application and development
of melphalan in hematopoietic stem cell transplantation.
This article has compiled the key contents of the conference for the readers
.


01 Chairman's speech


At the beginning of the meeting, the Executive Chairman, Professor Dong Yujun, presided over the opening ceremony and extended a warm welcome
to all participants.
Afterwards, the chairmen of the conference
, Professor Wu Depei, Professor Ma Jun and Professor Zhu Jun, delivered opening speeches
in turn.
Professor Wu Depei said that melphalan is mainly used in transplant pretreatment, which is basically a necessary drug
for ASCT in MM, lymphoma and plasma cell diseases.
Due to the lack of drugs available in the past, the development of ASCT in China was slow, and after the availability of drugs such as melphalan, ASCT in China began to flourish.

Professor Ma Jun said that he is very happy to see the domestic melphalan hydrochloride on the market, providing new weapons
for China's ASCT.
Alkeran®, the original product of Wanjia ® (melphalan hydrochloride for injection), has been listed in more than 50 countries including the United States, the United Kingdom, and Japan for more than 30 years, and has accumulated a lot of experience
.
With the rapid development of ASCT, the standardized use of melphalan hydrochloride is becoming more and more important
.
I look forward to inspiring more sparks at this conference, leading ASCT for lymphoma, myeloma and leukemia in China to standardize and internationalize, move towards the direction of developing a wider range of indications, and jointly help the development of ASCT discipline in China!
Professor Zhu Jun said that compared with Europe and the United States and other countries, there is still a gap in the number of ASCT in China, and the lack of pretreatment drugs is one of
the very important factors causing this situation.
The listing of domestic mephalan brings us more opportunities, choices and hopes
.
I wish this meeting a complete success!


Professor Dong Yujun served as the host of the opening ceremony


Professor Stephen Wu delivered an opening speech


Professor Ma Jun delivered an opening speech


Professor Zhu Jun delivered an opening speech


02Corporate speech


Liu Feitai, president of Xi'an Libang Pharmaceutical Device Industry Group, thanked the experts and scholars who attended this meeting, and delivered a speech: As the first generic drug of melphalan hydrochloride hydrochloride (propylene glycol solubilization) for injection in China, Wanjia ® has improved the accessibility of mephalan in China and made the once orphan drug no longer lonely
.
In the future, Libang will continue to conduct scientific research in the field of hematological oncology, and will help more new drugs in the field of hematological oncology to come out for the benefit of clinical patients
.


President Liu Feitai delivered an opening speech


03Academic session


After the opening ceremony, the academic session followed closely and began
in full swing.
The first session was chaired by
Professor Hou Jian from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine and Professor Liu Peng from Zhongshan Hospital affiliated to Fudan University
.
Professor Fu Chengcheng of the First Affiliated Hospital of Soochow University introduced the topic of "Clinical Application of Wanjia ® (Mephalan Hydrochloride for Injection) in Pretreatment of Hematopoietic Stem Cell Transplantation
".
Professor Fu first introduced the marketing process of Mephalan hydrochloride hydrochloride for Wanjia, and pointed out that its imitation was Alkeran's injection dosage form (lyophilized powder for injection, 50mg), and formulated the indications and dosage of Wanjia ® ® with reference to Alkeran's®® approval in the United States and Japan
。 Subsequently
, Professor Fu mentioned in combination with guideline recommendations and clinical studies that melphalan 200mg/m2 is the standard pretreatment regimen for MM patients, which is safe and effective in the pretreatment of lymphoma, adult leukemia and childhood leukemia ASCT and/or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Treatment regimens combined with melphalan are also well
used in neuroblastoma and retinoblastoma.
Finally
, Professor Fu introduced that the two forms of melphalan for injection include the original Alkeran® as the representative, the excipient is povidone, containing a special solvent, and Evomela®, the excipient is cyclodextrin derivative (sodium salt of β-cyclodextrin sulfobutyl ether), which does not contain a special solvent
.
Wanjia, the former is the first approved imitation, the safety and effectiveness are consistent with Alkeran, and the approved scope of application is wider than that of mephalan represented by Evomela ®®
.
®


Professor Fu Chengcheng gave a report


The second session was chaired by Professor Wang Xiaopei of Peking University Cancer Hospital, and Professor Liu Weiping of Peking University Cancer Hospital gave a report on the current situation and prospect of autologous hematopoietic stem cell transplantation in China from three aspects: national ASCT overview, lymphoma and MM ASCT overview in 2021
。 The report collected a total of 5221 cases of ASCT reported in 211 centers in 29 provinces and cities in China in 2021, and a total of 4556 cases of ASCT for the first time in lymphoma and myeloma, of which the ASCT utilization rate of lymphoma was 2.
4% and the utilization rate of myeloma ASCT was 11.
3%.

In terms of lymphoma pretreatment, the utilization rate of BEAM regimen is 59%, and a more unified pretreatment option
has not been formed.
In terms of myeloma pretreatment, melphalan monotherapy rate accounted for 87%, and the rest of the regimens were mostly based
on melphalan.
A series of multicenter retrospective and prospective studies in China have found that ASCT has brought good survival benefits to patients with mantle cell lymphoma, peripheral T-cell lymphoma and T lymphoblastic lymphoma.
On the whole, the degree of ASCT development in China is insufficient, and high-level evidence-based medical evidence is lacking, and it is urgent to train professional personnel and teams to carry out more high-quality clinical studies
suitable for Chinese patients.

*BEAM protocol: carmustine + etoposide + cytarabine + melphalan


Professor Liu Weiping gave a report


The third session was chaired by Professor Chen Wenming of Beijing Chaoyang Hospital affiliated to Capital Medical University, and Professor Li Xin of the Third Xiangya Hospital of Central South University gave a speech entitled "Autologous hematopoietic stem cell transplantation for the treatment of newly diagnosed multiple myeloma", from the status of newly diagnosed MM (NDMM) patients transplantation, The practice of ASCT in his center, as well as the three aspects of hematopoietic reconstitution and immune reconstitution after ASCT, were interpreted
in detail.
In the era of new drugs, ASCT is still an important treatment for MM, and domestic and foreign guidelines recommend ASCT as the first-line treatment
for NDMM.
For MM patients in China, ASCT is a treatment with higher valence
.
In the MM diagnosis and treatment path of the Third Xiangya Hospital of Central South University, the pretreatment scheme of ASCT is based on mephalon, and the classic pretreatment scheme is high-dose melphalan (200mg/m2), but the dose of melphalan can be appropriately increased or decreased
with different risk degrees and extramedullary MM.
Post-transplantation hematopoietic reconstruction is related to the number of CD34+ cells, previously used drugs, pretreatment, etc.
, and post-transplantation immune reconstitution is closely related
to prognosis.


Professor Li Xin gave a report


The fourth session was chaired by Professor Xia Linghui of Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, and Professor Wang Sanbin of the 920th Hospital of the PLA Joint Logistics Support Force introduced the application
of melphalan in the pretreatment of aplastic anemia (AA) transplantation.
Professor Wang Sanbin said that sibling HLA total compatibility transplantation (MSD-HSCT) is still considered the standard of care for young severe AA (SAA) patients, and non-blood HLA total compatibility transplantation (MUD-HSCT) is rising as the main treatment for SAA
.
At present, about 10% of patients still have rejection using standard pretreatment regimens of MSD-HSCT and MUD-HSCT, so some research centers have explored
mephalan-containing pretreatment regimens.
A retrospective study in Japan showed that bone marrow transplantation with AA with fludarabine plus melphalan was safe and effective, with 100% overall survival (OS) and 100
% event-free survival (EFS).
A study in 920 Hospital included 20 patients with AA who underwent haploid hematopoietic stem cell transplantation in 2020-2021, using a pretreatment regimen combined with melphalan, with a median follow-up of 307 days, and the incidence of graft-versus-host disease (GVHD) was 5%, and the OS rate and EFS rate of patients were 95%.


Professor Wang Sanbin gave a report


The fifth session was presided over by Professor Liu Qiqi of the Institute of Hematology, Southern Medical University, and Professor Jiang Erlie of the Hematology Hospital of the Chinese Academy of Medical Sciences gave a detailed introduction on the topic of "Optimization of Hematopoietic Stem Cell Transplantation Pretreatment Program".

Patients with high-risk acute myeloid leukemia (AML) and MRD+ intermediate- and low-risk AML are the main patient groups
of AML allo-HSCT.
A prospective, multicenter clinical study conducted by Professor Jiang Erlie's center explored the use of melphalan combined with maryland, cyclophosphamide and cladribine pretreatment regimen for relapsed/refractory AML prior to allo-HSCT, and the results showed that the regimen had good safety and efficacy, with a 1-year recurrence rate of 22% and a disease-free survival (DFS) rate of 71%.
Treatment-related mortality was low, at 7%.

In addition
, Professor Jiang Erlie said that in low- and medium-risk patients with persistently negative MRD, ASCT may be similar to fully compatible HSCT, and the replacement of donor allo-HSCT is slightly inferior
.
However, in patients with negative or persistently positive MRD, ASCT is less effective
.
Finally,
Professor Jiang Erlie introduced that his center is currently exploring the application
of melpharun combined with cyclophosphamide and cytarabine in acute lymphoblastic leukemia (ALL) ASCT.


Professor Jiang Erlie gave a report


04 Interactive session of big coffee


The session was chaired by Professor Cai Zhen from the First Affiliated Hospital of Zhejiang University School of Medicine and Professor Li Nainong from the Union Hospital Affiliated to Fujian Medical University, Professor Ji Jie from West China Hospital of Sichuan University and Professor He Pengcheng from the First Affiliated Hospital of Xi'an Jiaotong University , Professor Li Zengjun of Shandong Cancer Hospital, Professor Chen Shuping of Xiangya Hospital of Central South University and Professor Luo Yi of the First Affiliated Hospital of Zhejiang University School of Medicine served as panelists
。 They said that the listing of domestic mephalon has greatly improved the accessibility of mephalan in China, and has broad application prospects, and believe that it will play a greater role in promoting the development of ASCT in China, and also look forward to the continuous attempts and explorations
of mephalon in the fields of high-risk leukemia transplantation and secondary transplantation.
It is hoped that Wanjia ® can enter the medical insurance as soon as possible and bring benefits
to more patients.
The panelists also had wonderful discussions
on "the order of use of melphalan combined with other alkylating agents in transplantation pretreatment" and "the gap between ASCT in China and abroad".


Experts discussed


05 Summary of the conference


At the end of the meeting, Professor Dong Yujun summarized the meeting, he said that he thanked the four chairmen for their presence and guidance, the meticulous teaching of all the big names in the transplant industry in the academic session, and the active participation of all the moderators and discussion guests, I believe that the experts and scholars present and the audience gathered in the cloud can gain
something from this conference.
Finally, thank you again to Xi'an Libang Pharmaceutical Co.
, Ltd.
for providing this platform, and look forward to more in-depth cooperation
in the future.
Looking forward to meeting you in person next year!


The gap between China's ASCT level and foreign developed countries still needs to be crossed, and the uneven development trend of various regions in China needs to be reversed
.
® As the first generic drug melphalan hydrochloride hydrochloride (propylene glycol solubilization) for injection in China, with its safety and efficacy consistent with its original drug, it has a wide range of applications and broad prospects, and looks forward to contributing to the vigorous development of China's transplant industry in the future, and making unremitting efforts for the treatment benefits of patients and the realization of the grand goal of Healthy China 2030!


Professor Dong Yujun made a summary of the meeting


Edited by Hui-Y Reviewed: Irena Typesetting: Moly Executed by Cherry


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