Product: Hearti Cellgram-AMI
Country: South Korea
Company: FCB-Pharmicell
Approved: 2011-07
Indications: Acute myocardial infarction
Source: Autologous bone marrow mesenchymal stem cells
Unit price: 18 million won 丨 about 100,000 yuan
Sales: 17.1 billion won丨11 years
Try to match the moon landing Source: Pharmicell
2011
A shining debut
On July 1, 2011, the Korean Ministry of Food and Drug Safety (MFDS) approved the listing of FCB-Pharmicell's Hearti Cellgram-AMI for the treatment of acute myocardial infarction.
"This will be recorded as the world's first approved stem cell therapy."
Cellgram's treatment flow: within 72 hours, mesenchymal stem cells are collected from the patient's own bone marrow and cultured in the laboratory for about 4 weeks, then used by coronary angioplasty.
The clinical trial conducted by Pharmicell included a total of 80 patients, 40 in the experimental and control groups. Results after 6 months showed a 5.9% improvement in left ventricular ejection fraction in the treatment group, compared to the "global average of about 3%."
2017
Six-year period
Cellgram was approved under the condition that Pharmicell submit clinical data from 600 patients to the MFDS over 6 years.
In 2017, the MFDS rejected Pharmicell's application to reduce the number of people surveyed to 60, but adjusted to 100.
Pharmicell had trouble recruiting subjects, although by this time CellGram had generated sales of about 10 billion won, equivalent to selling more than 500 copies.
By the end of 2017, Pharmicell failed to submit data and was fined 13.95 million won by the MFDS.
At the time, some industry observers in South Korea speculated that their approval would be revoked.
Some civil society groups have called on MFDS to do so, "of the eight stem cell therapies approved globally, four are approved only in South Korea, and none are approved by developed countries." South Korea's approvals are too hasty and lack objective data. ”
Nature also commented that the approval process for Cellgram in 2011 was disappointing.
2020
Controversy and skepticism
In 2020, South Korean media outlet YTN launched an in-depth report on the controversy and skepticism surrounding Cellgram.
YTN's team reviewed Pharmicell's sales records and found that it was used to treat a variety of conditions, including amyotrophic lateral sclerosis, diabetes, stroke and anti-aging.
Moreover, there are suspicions that Pharmicell, while treating, froze the patient's stem cells without permission.
Joo-seong Kang (former CEO of HealthWorld Network): "Rare disease patients really want to grab a lifeline, you can't use this to make money. The patient gave his body and paid the price..."
Since Cellgram is a special drug, it is not covered by the Health Insurance Act. Therefore, there are no other punishments for the relevant behavior except for violations of the doctor's code of ethics.
2022
Advanced Biopharma
Aside from sales, Cellgram doesn't seem to have taken much of a hit.
In February 2022, MFDS announced that 15 cell therapy products, including Cellgram, have been re-approved as advanced biopharmaceuticals under the new Advanced Regenerative Medicine and Advanced Biopharmaceutical Safety and Support Act.
At the same time, through the commercialization of Cellgram, Pharmicell has been seeking to expand the indications and develop new cell therapies.
By the end of 2021, the current status of Pharmicell's new drug research and development is as shown in the following figure:
11 years
Market performance
In 2021, the total sales volume of "cell therapy" in South Korea was 78.3 billion won, accounting for 2.4% of the biopharmaceutical product market.
△ Source: Korea Biopharmaceutical Association, 2021 Biopharmaceutical Industry Trend Report, MFDS
Cellgram's performance ranked No. 7.
From 2011 to 2021, Cellgram sold a cumulative sales of 17.1 billion won (about 90 million yuan), but after 2020, sales plummeted.
However, this has had little impact on Pharmicell, which has been under 10% of its performance for many years.
Pharmicell's current main revenue comes from the Chemicals division (over 80% for a long time), and its sales of the API "nucleoside" have increased significantly due to the impact of the new crown epidemic.
Interlude: The world's number one contender
Have you seen The Cellgram experience and have doubts about the prospects of mesenchymal stem cell drugs?
Don't worry, there's one role model: Cartistem.
Coincidentally, the South Korean media also hyped their competition in the "world's first stem cell drug" that year. But today, Cartistem's annual sales have exceeded and stabilized at more than 10 billion won.
Why do they have different fates?
Is the difference in cell origin?
Cellgram's choice of autologous bone marrow mesenchymal stem cells may be partly because of safety and, on the other hand, it may be the bone marrow transplant specialist status of Pharmicell's founders. Cartistem's choice of cord blood mesenchymal stem cells is also related to Mediposta's operation of the cord blood bank.
Cellgram's developer is Hyun-Soo Kim, who was professor of hematology and oncology at Asia University before founding Pharmicell and served as the leader of the bone marrow transplant team.
Or is it a difference in indications and modes of administration?
India's Reliance Life Sciences also chose to use autologous bone marrow mesenchymal stem cells to treat acute myocardial infarction, and their product CardioRel has not been approved for marketing so far. Companies that have tried to treat this indication using stem cells include Stormustics in India and Miltenyi in Germany.
In 2017, a South Korean civil society group advocating the cancellation of Cellgram's license said: "The MFDS granted Cellgram marketing authorization based on data from only 80 patients, and wanted the title of 'the world's first stem cell therapy'." The modifier 'global first' is just an illusion. MFDS needs to reconsider the value of a 'global first' that no one acknowledges or doesn't believe. ”
But it's hard to predict the future of cellgram-AMI because South Korea places particular importance on international honors, "canceling the ratification will have a detrimental effect on the country's reputation, and we have to make a prudent decision." ”
Umbilical cord mesenchymal stem cells combined with antineoplastic drugs have a good effect in the treatment of lupus erythematosus
Globally listed mesenchymal stem cell drug inventory, how much is the price, and is it selling well?
Text | New life
Figure | New Life, pixabay