It is now time. We would like to begin the financial results presentation session of Eisai Co., Ltd. for Q2 fiscal 2021. This session is live streamed and distributed to those who are participating from telephone line. Those of you who are participating through teleconference, please download the slides from our website and please click forward. Those of you who are watching live stream, please continue to watch the screen. Now let me introduce the presenter today, Mr. Haruo Naito, Representative Corporate Officer and CEO. Now over to you, Mr. Naito, please.
Thank you. This is Naito speaking. Now, I would like to report to you the results recorded up until the end of Q2 this fiscal year. Now, here are overall P&L. As you see in the headline, LENVIMA and other global brands, four in total, have steadily grown. Moreover, two of two and other strategic options have been made in timely manner. Therefore, we have been able to secure favorable results. For the first half, revenue was JPY 362.4 billion, up 14% year-on-year. Cost of sales was improved by 3.1 percentage points from a year earlier due to product mix improvement and also receipt of milestones and one-time payment and so forth. Gross profit grew almost 20% from a year earlier, at 19% from year earlier, making steady increase.
R&D expenses and SG&A expenses, lecanemab and LENVIMA. At crucial points in development of these, we allocated resources proactively. If you look at total expenses, which were JPY 221.6 billion, up 9% from the previous year. Increase in total expenses was controlled within the increase of gross profit. We believe that there was a financial discipline, to some extent, to control the expenditures. Operating profit was JPY 60.9 billion, up 79% from previous year. Significant growth was recorded. ROE for the interim period was 12.9%. As I said, regarding revenue, increased by JPY 45.3 billion, out of which the impact by Forex was JPY 13.7 billion. Regarding four global brands, I would like to use the next, following slide to explain.
In top left, LENVIMA reached JPY 91.8 billion, up 34% year-on-year, showing very robust growth. In the middle, HALAVEN. In China, Patient Assistance Program, or PAP, has been applied, which led to expansion of patient access. Therefore, HALAVEN grew 7% year-on-year. Steady growth. Bottom left, FYCOMPA, AMPA receptor antagonist only available, already available, agent in all regions. Monotherapy was promoted as well, therefore FYCOMPA grew in all regions. Bottom, in the middle, DAYVIGO, orexin receptor antagonist. It's shown in Japan in May of this year, the restriction of administration has been lifted. Since then, we have seen significant growth. As you can see, a very high growth ratio was recorded from a year earlier. In total, four global brands recorded JPY 133.2 billion, up 32% from a year earlier. Now, turning to revenue in regions.
The region revenue grew 4% year-on-year to increase it by JPY 12.3 billion. In Japan, as you see in these bullet points, there was the generic of Alitica launched, and also there was an impact of drug price revision and the transfer of rights for Treakisym. In total of these, there was a minus or negative impact of JPY 17.5 billion in Japan. Now turning to region analysis. On the right-hand side, as I said earlier, in Japan, the revenue was 78.7% of the previous year. Americas, its growth of 18% year-on-year has been shown. In China, LENVIMA has been posted on the National Reimbursement Drug List, therefore access has been significantly expanded.
Given these, the revenue was JPY 58.9 billion, up 28% year-on-year. Rapid growth was shown. EMEA, LENVIMA also have shown their steady growth in Asia and Latin America as well. The revenue in pharmaceutical business was JPY 308.4 billion, up 4%, and a profit was JPY 146.5 billion, up 14% year-on-year. In the bottom left, as you can see here, is the ratio of each region's revenue to the total revenue. In Japan, the share of Japan has declined while we saw increase in share by America. 27.4%, which is written outside the pie chart, this is the combination of China and Asia and a part of the Latin America.
Combining these regions, 27.4%, very high ratio was taken by these regions. This is the outstanding point. At the very bottom of this slide, number four, implementation of strategic options, MORAb-202 related strategic collaboration concluded with BMS and which brought about a positive impact of JPY 49.6 billion. At the very bottom, you can see the alliance sales revenue total because of the transfers of those sales rights for Noixil and Aciphex. Last year, we recorded the impacts of the transfer of rights for tazemetostat in Q1 last year, and which was the JPY 11.5 billion negative. In total, license revenue total impact was JPY 43.6 billion.
Here, operating profit grew 179% and/or plus JPY 26.8 billion yen, impact of Forex of JPY 5.6 billion yen. A proactive investment was made into R&D expenses for LENVIMA and other global brands. The share, the profit paid to Merck in the amount of JPY 41 billion yen for LENVIMA, which was an increase by JPY 11.3 billion yen year-on-year. But we believe that this was very proactive investment. A proactive investment was made also in Aduhelm, which was increased by JPY 6.6 billion yen from a year earlier. Regarding these expenses, financial integrity has been kept in making these investments. Divestiture of rights for Zonegran in Europe, the gains from this divestiture in the amount of JPY 14.7 billion yen was recorded in other income and expenses.
Now, turning to items on balance sheet. Equity ratio stood at 46.41%. We believe that we have maintained a strong financial structure, and net DER is - 0.3 times. Net cash is JPY 219.1 billion. Assets with potential impairment risk in total accounted for 34.2% of net assets. Therefore, we believe that we have a very strong balance sheet. From BMS, in addition to what was recorded in revenue, R&D reimbursement of JPY 21.7 billion was received from BMS on top of what was included in the revenue. This was recorded as deposits received. R&D expenditures, which will be incurred for MORAb-202, will be spent from this deposit. Free cash flow was JPY 60.5 billion.
Now, we'd like to open a new chapter of Alzheimer's disease treatment with Aduhelm and lecanemab updates. Update is going to be given here. Now, I'd like to talk about updates on Aduhelm or aducanumab. There are four points to improve community's understanding of clinical data as well as value of the treatment and expand amyloid beta diagnosis based on amyloid beta and clarity of reimbursement for AD-DMT and increase visiting at medical sites and the support infrastructure for infusing. In the United States, new treatment approaches in this very critical disease familiar to many of us, Alzheimer's disease, new rising therapies to come around. There are many points to be overcome towards which we are trying to make utmost efforts together with Biogen to address each of these issues to be overcome.
I would appreciate if you could understand this. Clinical data and the value of the treatment should be understood more by the community. As we wrote in this first bullet, the results from EMERGE, ENGAGE clinical trials. Now, the article is being currently under review at the top-tier journal. A final review process is ongoing now, and we are expecting that this article will be published soon. Regarding these phase III studies, articles regarding such results from the studies will be reviewed by a top-tier journals and to be published. Once that is realized, it will increase the reliability and trust in the clinical data. Suppose that there will be adoption or listing by medical institutions going forward of this drug. I believe that once the publication is made, it will bring about a great positive impact on the listing.
Then next, how much the value of the treatment with aducanumab will be, particularly for patients and their families, and that is going to be crucial. The basis for such value of treatment based upon the EMERGE study EMERGE simulation was conducted. In aducanumab treatment, how long the duration of transition from MCI to moderate AD could be prolonged by this treatment with aducanumab. Regarding the long-term clinical benefits of aducanumab based upon such simulation in August this year, the article regarding such analysis is published in Neurology and Therapy. Other than that, articles related to the value of the aducanumab treatment is now being submitted for publication. Transparency of the clinical data as well as the value of the treatment of aducanumab. The substantive understanding will be further promoted by these publication activities.
Second point regarding the expansion of amyloid beta diagnosis. Of course, the scope of amyloid PET imaging reimbursement is only allowed for clinical trial use. However, there are various negotiations and discussions ongoing in order to expand the scope of reimbursement. Biogen and Eisai are also promoting the use of a CSF amyloid beta testing through utilization of free access support program. The number of patients who are using this free access support program is increasing compared to the end of September. Now, the number today has been doubled in terms of the number of patients who are utilizing this support program. Clearly, for a further use of Aduhelm, steady steps are being made one by one. The third bullet here, we'd like to discuss blood testing for diagnosis.
Like in the case of hemoglobin A1c for diabetics, we think that there will be such effects in blood testing. C2N Diagnostics, a testing to measure amyloid beta 42/40 ratio and APOE4. Such services have been initiated by C2N Diagnostics, and we expect that increasing a certain number of patients are going to utilize such services for testing. For regarding the next bullet point, clarity of reimbursement for AD-DMT. Now NCD is being analyzed and with draft NCD decision expected in January next year, and it will be finalized by April next year. Guidance will be issued at that time. This analysis is not for Aduhelm amyloid beta reduction targeting AD-DMT antibodies. In addition to Aduhelm, this NCD, National Coverage Determination, will be applied to other antibodies. This is the current framework.
When it comes to these very innovative drugs for targeting reduction in amyloid beta, most modern sciences and technologies are gathered for bringing about this breakthrough medicine. We needed to secure the access by those patients who really need such therapy. We believe that this is very critical and indispensable in the modern society. Guidance shall be presented, which will allow such realization of the access by the patients who need it. Regarding the examples of reimbursed cases by medical Medicare Advantage plans, for example, Humana, which is one of the large operator, has initiated coverage for patients who meet a phase III trial entry criteria. The fourth bullet is to increase listing at medical sites and support infrastructure for infusion. Currently, Aduhelm is being infused at approximately 120 sites.
At the end of September, compared to the end of September, the number has been almost doubled. With such a high speed, the number of institutions is increasing. I think that we expect to increase the number gradually. The conclusion statement here at the bottom. With AD-DMT, we are pioneering a new chapter in AD-DMT. We strongly believe that these efforts will be in full bloom to reduce the burden of patients and their families, and also by the society at large.
We believe that such approach and treatment will bring about the hope and dream. We are sure that these efforts will be becoming full bloom soon, and Aduhelm as well. The spring when Aduhelm flower will be in full bloom, it will not be so far into the future. Now, I would like to discuss lecanemab, which is to follow Aduhelm. AD-DMT leading position is what we are aiming at. Currently, we are making efforts to establish a leading position in AD-DMT. This page describes four important points regarding lecanemab, which I would like to discuss today. First is robust amyloid clearance. Within 18 months amongst target patients, approximately 80% were converted to an amyloid negative, and robust removal capability of amyloid was displayed. In Study 201, Abeta reduction and outcomes were used at endpoint, and these correlate.
This was shown in statistically significant fashion. Next is about dose. 10 mg/kg biweekly. At this dose, favorable safety profile was observed. In this case, to be more specific, ARIA-E. The ARIA-E incidence with lecanemab was 9.9%. Regarding other antibodies, the incidence of ARIA-E for other antibodies, I'm sure you are aware of through various publications or announcements. ARIA-E incidence with lecanemab is by far very low. As for APOE4 carriers, among APOE4 carriers, ARIA-E incidence was sustained at 14.3%. That's showing a favorable safety profile of lecanemab. The third point is early treatment effect. Because of low incidence of ARIA-E, titration is not required. From the initial dose, effective dose can be realized. First dose is an effective dose.
Naturally, the most important performance of the drug, which is the early onset of the efficacy, is strongly expected with lecanemab. That is a major advantage for lecanemab. I will be showing this in the next slide by using blood biomarkers. Lecanemab, various conditions can be measured, and therefore, dosing regimen of lecanemab and designing of the dosing may be able to utilize blood biomarkers. As shown in the last bullet point, subcutaneous formulation is being developed, including self-injection. Subcutaneous formulation will be developed, and we hope to increase convenience. The fourth point is confirmatory study of lecanemab. We are aiming for rolling submission of accelerated approval. After complete study, we are aiming for full approval, naturally.
What is necessary for full approval is one confirmatory study, which is Clarity AD study, and this study is underway steadily, and readout is expected in Q2 FY 2022. AD-DMT antibodies, phase III study in comparison to other antibodies, we believe that it will be one of the earliest to have the readout, and it may be a drug that is nearest to receiving full approval status. Based on accelerated approval pathway, we have initiated rolling submission of BLA. Rolling submission, we would like to complete a rolling submission in the first half of calendar year 2022. For that, we are putting all our efforts so that we are able to complete rolling submission in the first part of calendar year 2022. I mentioned in passing earlier of plasma Abeta 42/40 ratio for lecanemab, and this is the data.
As you may be aware of already, the left side is PET SUVR change in Study 201 core period in the 18 months and two years of gap period, and then open-label extension study period. Horizontal axis shows the chronological timeline, and the vertical axis is SUVR. On the right chart, Abeta 42/40 ratio is shown. Abeta 42/40 ratio reduction is shown. This slide is, top side and downside are reversed from SUVR. However, when we compare SUVR and Abeta 42/40 ratio, they behave almost in a similar way, suggesting correlation. Core study and after a gap, then OLE study was carried out. Data from such study design, I believe, is only from lecanemab. In that sense, this is a precious data.
When looking at gap period of off treatment amongst the patients who were given placebo or active dose, there is a gap, and that gap is maintained during the off-treatment gap period. This gap does not change much. Slightly, there was a slight increase in accumulated Abeta during the gap period. Without any drug administered to spend time might lead to, once again, increase of Abeta. That may be the suggestion of the data. Blue line in the placebo arm at this timing of the start of OLE, when lecanemab, the active dose, is given, rapidly amyloid beta reduction is observed. Plasma Abeta 42/40 ratio, how it can be used and in development of dosing regimen. Plasma Abeta 42/40 ratio will be a very important data, and that is why I wanted to share that with you today.
Now, Eisai has a pipeline in the clinical stage for Alzheimer's disease-modifying therapy. Four drugs are shown on this slide. In the medical, clinical, pathophysiological development, because of that development, currently, when we look at ATN, amyloid, tau, and neurodegeneration, these are continuous change in pathophysiology, is understood as the pathophysiology of Alzheimer's. I believe there is generally a consensus on this. At each stage, we have very strong theme, and as such, Eisai is a unique existence. We believe that in that sense, we have a leading position globally. Disease stage is shown at the bottom of the slide. As for lecanemab, from pre-clinical AD to mild AD, the wide range can be covered by lecanemab. With SNAPS, Regeneron, to late stage, an option may be offered with the tau antibody in the middle.
Well, currently, there were reports of failure of various tau antibodies, but so far, this development is underway smoothly. These lines are overlapping, suggesting combo therapy going forward. In particular, regarding lecanemab and E2814 anti-MTBR tau antibody, with the world-renowned academic groups, we have collaboration underway. This, I believe, is a testament that these drugs are highly evaluated by the academia. ACTC, Alzheimer's Clinical Trials Consortium, which is a consortium of top academic institutions in the United States, has selected lecanemab for preclinical AD. Phase III study AHEAD 3-45 is being carried out. This is a phase III study for regulatory purposes. If this is successful, then indication may be expanded to early stage of the disease.
On the right side, for E2814, centering around Washington University, DIAN-TU group is formed to look at tau drug in dominantly inherited Alzheimer's disease group. E2814 was the first to be chosen amongst other drugs in the same class. This is looking at hereditary Alzheimer's patients, but we are also preparing phase II study for sporadic Alzheimer's patients. I would now like to report to you our efforts in oncology area. Oncology treatment options are driven by new technologies with novel drugs and a combination of novel drugs. That is the day and age that we are in. With that, we would like to establish franchise for multiple cancer types. Central, what is central for this is Lenvima.
The current sales for the first half is JPY 98.1 billion, and full year target is JPY 181.5 billion. The main market is the U.S. market, but in China, as shown on the left, revenue has more than doubled. There is a dotted line in the left chart. In this fiscal year, there are two sales milestones. If we achieve these milestones, we will be able to receive one-time payment from Merck. This graph shows that in calendar year and in fiscal year, we have milestones. Solid lines, red is from January to now, and blue is from April to today. Actual result is shown, and this shows a steady advance.
We are in line with achieving milestones. We have strong conviction that we will be able to achieve the milestones, and that should be positive upside events. On the right side, indications are shown. Currently, for five cancer types, we have received indications. For each, we have solid shares. Company-wide oncology, commercial, and medical resources are increased. In the United States, direct visits, in-person visits have increased to almost triple the level from the previous year. In the meantime, to respond to COVID-19 pandemic, various digital tools were also developed. All of these put together, we were able to strengthen customer engagement capabilities. In this fiscal year, we have received two new indications. First is advanced EC following prior systemic treatment. In the United States, full approval was given. In EU, positive EU CHMP opinion was given.
In Japan, it's under priority review as orphan drug designation. For advanced RCC, first-line approval was given in the U.S. In EU, positive EU CHMP opinion was given. In Japan, review is underway under a standard timetable. Before the end of FY 2021, we hope to receive approval in Japan. First, renal cell carcinoma. RCC patients. What are the desires of RCC patients are shown on the left. Of course, clear elimination of disease, complete response is most desired. In the middle, base of the indication, clear study results are shown. CRR was 16.1%. In comparison to other treatment options, CRR, superior CRR was achieved. As for this complete response ratio, this has brought about various other effects. At 24 months, survival of these patients was 100% in case of complete response patients.
This leads to extension of overall survival. On the right side, the arrow indicates what we have done in RCC area. In 2016, in combination with everolimus, approval was given. With KEYTRUDA combination, approval was given. Now, phase III study as a first-line in combination with belzutifan or MK-1308A are underway. As a second and third line, in combination with belzutifan, phase III study will be carried out is ongoing. Franchise development efforts between Merck and Eisai will continue. Next is EC. Endometrial carcinoma. Study 309 led to approval. In EC, so far, chemotherapy was the mainstream therapy. Chemotherapy-specific hair loss or numbness and pain in hands and foot were side effects that led to deterioration in quality of life.
LENVIMA plus KEYTRUDA is a chemo-free treatment option, which is expected to improve quality of life in these respects. As for first-line combination, phase III study 001 is also underway. We expect the results before the end of fiscal 2021. We would also like to establish strong franchise with EC. Now, turning to HCC, hepatocellular carcinoma. As you are aware of, HCC treatment is such that Japan is leading treatment for HCC. REFLECT study is phase III study for LENVIMA monotherapy and this led to approval. Japanese KOLs have contributed much wisdom in the conduct of this study. For example, surgical treatment combination or as shown in the middle, combination with TACE were ideas contributed by the surgeons in Japan.
One such combination LENVIMA, KEYTRUDA, and TACE combination is used in phase III study, which is underway right now. LENVIMA, KEYTRUDA, HCC first-line phase III study is also underway. We would like to obtain results before the end of fiscal 2021, as shown in second from left. On the right, MK-1308A and LENVIMA combination HCC first-line study, phase II study is also ongoing. Important cancer type HCC. For the patients of HCC, we would like to be able to give them hope. We would like to fulfill our role of developing new treatment options one after another for HCC. LEAP studies HCC1L, EC1L, I have already discussed.
NSCLC1L first-line and melanoma first-line phase III studies are also being carried out. As shown on the right side of the page, in early phase, we would like to obtain strong clinical data. We obtained a strong clinical data based on which phase III studies were designed. We would like to obtain results between 2021 to 2022. Next is MORAb-202. This is a strategic alliance product with BMS. Structure of MORAb-202 is shown here. I would like to point out that our payload is eribulin, HALAVEN. This is in-house developed product. Antibody was developed by former MorphoTek, Farletuzumab, anti-folic acid receptor antibody. Four Farletuzumab antibodies are linked with linker to eribulin. This linker is also a result of a superb scientific technology of Eisai. That is the ADC that we have.
As shown in the middle, we hope that this will become the best-in-class of the next generation ADC. That is because it has favorable characteristics. In blood and in cell, this is less prone to aggregate. This is because four antibodies per one molecule of HALAVEN are exerted in terms of its performance through a good linker. If our positive target cancers will take in this, and immediately the linker will be cleaved, and eribulin will exert cancer killing cell action. This is rapid and effective, efficient. In cancer cells, after cancer killing action of cancer cells, eribulin will further be released to affect positively cancer microenvironment. What is known is that in there is a positive cancer effect on mesenchymal stromal cells. Therefore, MORAb-202, we consider is a next generation ADC.
On the right side, FR-alpha expression sites are shown with BMS. We plan to study global registration. We plan to start global registration studies in 2022 in collaboration with BMS. Lastly, I would like to discuss expansion to a new region, expansion to Africa with a base in India. African continent will see increase or boost of population, and economically it will become an engine of the global economic growth. It is a promising region, and we would like to consider India as a place that will play leading function vis-à-vis Africa. SADC, Southern African Development Community, centering around South Africa, and EAC, East African Community, centering around Kenya, we would like to make advances. Commercial purpose exists, but at the same time, we would also like to achieve SDGs. This, in very essence, is about achieving SDGs.
For one thing, in African region, there are tropical diseases, including neglected tropical diseases, and many people are suffering from tropical diseases. We are engaged over two decades in development of new treatment for tropical diseases, including mycetoma, leishmaniasis, lymphatic filariasis, malaria, tuberculosis, and others, in collaboration with GHIT Fund and DNDi. We would like to be on the ground doing this, especially centering around Kenya branch office to be established soon. We would like to continue our solid effort in development of new treatment for tropical diseases. Next is Price Zero business, where we provide a drug for free. This is considered business, and that is why we call this Price Zero business. At the center of this is DEC tablets, diethylcarbamazine tablets. This is indispensable in treating lymphatic filariasis. More than 2 billion tablets are supplied to 28 countries.
These tablets are 100% produced in Vizag plant in India. Vizag is also producing APIs, so it's a very important location. DEC tablets from the very beginning are 100% produced by Vizag plant. For SDG purposes, Vizag is also playing very important role. Centering around Nairobi in the community, on the ground, we would like to carry on our activities, and I think that will be a very important part of achieving SDGs. We would also like to introduce new drugs smoothly. In low-income countries, it is often said that the latest medical achievements do not reach these countries easily. We would like to engage in introducing new medicine in African countries as a part of SDG-related efforts.
In SADC or EAC region countries, HALAVEN, FYCOMPA, LENVIMA, DAYVIGO, these new medicines are soon to be approved, as shown in this timetable. We would like to make sure that there will be access to these drugs in Africa. The health of African people is very important, so we would like to remove concerns about health and gaps in healthcare. This is my last slide showing the full year forecast. On the right side, previous disclosure as of August is shown. More than 30% upward revision of operating profit was made. We made upward revision, and this is the second upward revision. Revenue was revised upward to JPY 730 billion. Operating profit was revised upward to JPY 78 billion from JPY 701 billion and JPY 76 billion respectively. This is supported by our global efforts.
In the second half of the year, LENVIMA, Aduhelm, lecanemab will continue to receive resource investment. As I have mentioned earlier, we will have strong financial discipline that is within the growth of revenue and profit we will be making expenditures. We will observe such strong financial discipline while we make proactive investment of resources. Operating profit of JPY 78 billion is forecast. This is an increase year-on-year of 51%. EPS is JPY 211. ROE is 8.4%. Based on sound finance, we plan to pay dividends of JPY 160. That concludes my presentation. Thank you.
Now we would like to start Q&A session. Today, we'd like to receive questions first from those who are participating by telephone. Please press asterisk plus one. We would like to connect you one by one. We would like to entertain questions from as many people as possible, so we'd like to receive one question per person. We are now currently receiving one. The first person from Citigroup Securities, Mr. Hidemaru Yamaguchi. Mr. Hidemaru Yamaguchi of Citigroup Securities.
Yes, this is Hidemaru Yamaguchi speaking. Can you hear me?
Yes, we do hear you.
Thank you. I have one question. In America, current status of Aduhelm? Thank you for the explanation. Towards becoming a big product in the emerging market, I understand that you are doing various activities. Biogen's management did not expect much revenue, but it has been slower than expected. That was the comment made by management of Biogen. Regarding this situation, for the short term, there are various hurdles based upon that. What are the issues and problems? What should be done? I think there are various things that should be done in short term as well as medium to longer term. What is most important to be done in short term? Do you think that you have to wait until NCD to be finalized? For short term, as the management of Eisai, could you please give us your take or feeling as the management of the company?
Thank you for your question. I think I have touched upon that in my presentation today. EMERGE, ENGAGE studies are ongoing, and regarding the transparency of the data from those studies and objectivity of the data. Various discussions are ongoing. As I said earlier, the analysis from the data from these studies will be published in top-tier journal. I don't think it will take much longer time because final review is ongoing. I think that this publication, once realized, will lead to resolution of the situation. Among patients, there are some patients who are asking why Aduhelm is not being prescribed to them, and they are repeating such question. Of course, NCD to be finalized and concluded within six months. For AD-DMT antibodies, NCD will be considered a must for AD-DMTs.
Such a breakthrough innovation, we believe that access should be secured with a guidance to be issued going forward. We have expectation to such guidelines. At which timing should we expect such guidance to come? Not far in the future. Within six months or so, I think there will be a big transition in phase. That's why we have been making various efforts.
Thank you very much. Next from Nikkei, Akama-san, please. Akama-san of Nikkei newspaper.
Can you hear me? I'm Akama from Nikkei. Thank you. I have one question. Eli Lilly's donanemab or Roche, Switzerland has gantenerumab. These competitors are also preparing to file submission. On this situation, what is the view of Mr. Naito, CEO, and what is the positioning of Aduhelm and lecanemab? How do you think you can differentiate vis-à-vis competitors?
Thank you for your question. When we think about drugs, we will have to look at category of drugs. Oftentimes, a class of drugs in multiple numbers emerge at the same time, and this is rather a positive thing. There will be greater understanding of that group of drugs within the community. On top of that, these four drugs are drugs that have clear characteristics. In the end, the characteristic of the drug may also be determined by the label given by FDA. Depending on the FDA label, there is much that will be determined in terms of the characteristics of the drug. In case of lecanemab, titration is not necessary. From the beginning, effective dose can be administered. This can be a major characteristic of this drug. Increasing number of drugs in the same class overall is something that we welcome.
Regarding our drugs, we are confident that we are able to position our drugs with their characteristics effectively.
From Morgan Stanley Securities, Mr. Muraoka. Mr. Muraoka, Morgan Stanley, please have the floor.
Thank you. Good afternoon. This is Muraoka of Morgan Stanley speaking. For lecanemab BLA rolling submission to be completed, and you mentioned the timing for completion. Earlier, Mr. Naito said by the end of first half in the period from January through June next year. Could you please specify further, for example, in the first half of next year, Q1 or Q2, January-March or April-June? So could you please specify a little further when you are expecting to see the completion?
It's a hard question, Mr. Muraoka. I'm perplexed. When I say in the first half of next year, that is the first half.
Understood. Okay. I'm expecting to hear further detailed explanation. Maybe you will still say that it is in the process when you are speaking at the information meeting to be held in March.
Well, I was considering how to say yesterday, but when I say the first half of the year, please understand it will be the first half.
Understood. Thank you.
Next, Mr. Sakai from Credit Suisse, please. Can you hear me?
Yes. This is Sakai. Can you hear me?
Yes, we can hear you. Please go ahead.
Thank you. Question about page 10, lecanemab, and it says biomarker, and I think it's certainly a biomarker. Last time or in the presentation before last, I think this was also shown in clinical symptoms improvement or deterioration to back up the biomarker data. Do you have such data? This is simply the change of amyloid in the blood. Unless you have other background data, it will simply be a change of amyloid in the blood. Do you have other background data?
This will be addressed by Ivan Cheung, Neurology President.
Thank you very much for the great question. Actually, later on this month at the CTAD Congress, we will show additional analyses based on this data. For example, on slide 10, you see the changes in PET and also the changes in plasma Aβ 42/40 ratio. At the CTAD Congress, we will also explain the correlation with clinical endpoints such as ADCOMS, both at the population level and at the individual level, correlation with both PET and plasma Aβ 42/40 ratio. Stay tuned. Thank you.
Thank you very much. Next from JP Morgan Securities, Mr. Wakao. Mr. Wakao from JP Morgan.
Yes, this is Wakao speaking. I'm from JP Morgan. Regarding Aduhelm, I have a question. By the end of the year, approval in EU and Japan will be more visible. If you have any updates on this, please give them to us. In Japan, suppose that Aduhelm is approved, and then another event will be to list the drug on the reimbursement list. With the drug price, I think that. Do you think that the market penetration will be progressing as you expected, like in the situation in the United States and after the launch of the drug, and then Aduhelm or amyloid beta-related issues or hurdles or challenges for penetrating this drug in Japan. Are there any implications that you have been starting to see?
Thank you for your question. I'd like to invite our Neurology President, Mr. Ivan Cheung, is going to respond.
Thank you very much for the question. We are working very hard with our partner Biogen in our dialogue with the PMDA in Japan and of course with EMA in Europe. We of course will further provide updates as those processes are further advanced. To your question about Japan, of course you are correct. The approval and then the price listing, that process is only within two months. As you can see here, we discussed earlier in the United States, approval in June this year and then the NCD decision by April next year. That's a 10-month process. In Japan, that will be a two-month process. Obviously, we believe the access issue in Japan will be addressed in a much more speedy manner. That's our thought. Thank you for your question.
Well, this is Naito speaking. I would like to supplement explanation about the Japan situation. Amyloid beta confirmation, of course, will be indispensable. Therefore, PET test and CSF test will spread in this market. I mean, in terms of the capacity of PET testing as well as coverage by insurance reimbursement. Regarding these matters, there needs to be a consistent approach in addressing these events. There are industry players and academia or congress, academic societies. With high transparency, we would like to keep close communication with those relevant parties. If and when approval is granted for Aduhelm, we would like to take consistent approach in timing and such confirmation of amyloid beta becoming available. We are making utmost efforts to be consistent in all these matters.
Thank you very much. Understood very well.
We would like to receive last question. Mr. Kotani from Nomura Securities, please.
Thank you. This is Kotani from Nomura Securities. Can you hear me?
Yes, we can. Please go ahead.
About Aduhelm, initial year revenue is quite limited. Even before launch, Eisai and Biogen were saying that it would be limited. The revenue being limited is not a surprise. There was no Alzheimer's disease drug and there is no established diagnosis and a questionnaire has to be undergone. MRI scan is necessary. Whether amyloid beta exists or not, PET testing is necessary, but it's not covered by insurance. I think a series of infrastructure cannot be developed overnight. My question is, well, I was able to understand the outlook for the revenue of Aduhelm. But about these diagnostics, about the diagnostic infrastructure, how advanced is it? What is the bottleneck? Could you elaborate on this? Regarding diagnostics infrastructure, when this is developed and in view of imminent launch of donanemab and lecanemab, how much of an advantage does Eisai have?
Ivan Cheung will respond.
Thank you very much for the question. You already know that we have a sponsored testing program on CSF, and the usage has accelerated quite a bit in the past month. That's very important to educate physicians and facilities how to do that. The second thing, which I'm sure you know very well, is the insurance coverage of a PET by Medicare. Right now, the Medicare coverage of a PET imaging is quite restrictive. You have, I'm sure, heard from Biogen that a lot of efforts are underway to work with the CMS to update that coverage for PET imaging.
A lot of patient groups and academic societies in the United States are also working, communicating very closely with the CMS on this matter. We do believe that update will come soon and that obviously will open up the market for all the antibodies, not just for Aduhelm, but also for lecanemab. For us, we believe the biggest opportunity lies in blood tests. This is an area that we are putting our most focus and resources into enabling a simple patient journey going forward. Thank you.
Thank you very much. I have a request to Mr. Naito. I know that your presentation materials and IR materials are very detailed and very clear because there are the citations and references to the literature as well. I think that with only 15 minutes for just question and answer, I don't think that all the question can be covered within such a short time. Could you please extend the IR meeting from 60 minutes to 90 minutes so that we can have 1 hour for Q&A?
Well, thank you very much for very good suggestion. I have been practicing several times in order to shorten my presentation time to secure as long time as possible for Q&A session. Together with IR team, we would like to consider your suggestion seriously. Thank you. Thank you very much. Please.
Now with this time approaching to the closing time, we'd like to conclude today's briefing session for the results for the first half. Thank you very much for taking time out of your busy schedule.