Manabe speaking. Thank you very much for joining Daiichi Sankyo's financial results presentation out of your very busy schedule today. I'm going to explain FY 2022 second quarter financial results we announced at 1:00 P.M. on Monday, October 31st, Japan time, based on our presentation materials. Please turn to page three. Today, I'm going to cover FY 2022 second quarter consolidated financial results, FY 2022 forecast, and business update in that order. Then Wataru Takasaki, R&D division head, will explain our R&D update. We will entertain your questions at the end. Please turn to page four. This is an overview of FY 2022 second quarter consolidated results. Revenue increased by JPY 77.8 billion, or 14.7% year-on-year, to reach JPY 607.8 billion. Cost of sales decreased by JPY 13.2 billion from the previous year.
SG&A expenses rose by JPY 44 billion, and R&D expenditure increased by JPY 44.8 billion year on year. As a result, core operating profit increased to JPY 84.8 billion, up by JPY 2.1 billion, or 2.5% year- on- year. Operating profit, including temporary gains and losses, increased to JPY 95.6 billion, up JPY 10.8 billion, or 12.8% year- on- year. Profit attributable to owners of the company was JPY 58.3 billion, down by JPY 4.2 billion, or 6.7% due to an increase in income taxes, et cetera. As for the actual currency rates, the U.S. dollar was JPY 133.98 . The yen depreciated by JPY 24.18 against the dollar year- on- year.
The Euro was JPY 138.72 . The yen depreciated by JPY 7.83 against the Euro. Please turn to page five. From here, let me explain positive and negative factors for revenue compared to the previous year. Revenue increased by JPY 77.8 billion year-on-year. I'd like to explain its breakdown by major business unit. First, in Japan business, sales increased for direct oral anticoagulant Lixiana, pain treatment Tarlige, and vaccine business. As I will explain later, gains on sales of products in U.S. and EU also contributed to Japan business responsible for the rights to these products. Sales decreased for proton pump inhibitor Nexium with the end of joint sales promotion in September last year, so Japan business revenue decreased by JPY 19.9 billion. Next, let me explain our overseas business units. Forex impact is excluded here.
In oncology business, sales decreased for products transferred in August this year, but sales of anti-cancer agent Enhertu grew in the United States and Europe, so revenue increased by JPY 26.9 billion. As for American Regent, sales decreased for iron deficiency anemia treatment Injectafer, but sales increased for iron deficiency anemia treatment Venofer and generic injectables. As we will explain later, products of HBT, which we acquired in August, also contributed as well. American Regent revenue increased by JPY 0.2 billion. Revenue for EU specialty business increased by JPY 4.1 billion due to an increase in Lixiana sales. As for Enhertu and Dato-DXd upfront payment, et cetera, related to a strategic alliance, revenue we recognized increased by JPY 17.1 billion.
We booked a total of JPY 15.7 billion as regulatory milestone related to the approval of Enhertu for U.S. and EU HER2-positive breast cancer second-line, U.S. HER2-low breast cancer post-chemotherapy, and U.S. HER2-mutant NSCLC second-line. Forex impact increased our revenue by a total of JPY 43.4 billion. Page six shows positive and negative factors for core operating profit. Let me explain the profit increase of JPY 2.1 billion by item. As I explained earlier, revenue increased by JPY 77.8 billion, including the increase of JPY 43.4 billion due to Forex impact. Next, I will explain cost of sales and expense items excluding Forex impact. Cost of sales decreased by JPY 22.8 billion.
Revenue increased, but COGS ratio improved by changes in product mix as sales increased for our in-house products such as Lixiana and Enhertu. SG&A expenses increased by JPY 25 billion due to an increase in Enhertu related profit sharing with AstraZeneca, et cetera. R&D expenditure rose by JPY 28.6 billion because of an increase in R&D investments for the three ADCs. Cost increased due to Forex impact by a total of JPY 44.8 billion. Core operating profit increased by JPY 3.5 billion excluding Forex impact. Next, page seven shows positive and negative factors for profit attributable to owners of the company. As I explained earlier, core operating profit increased by JPY 2.1 billion, including Forex impact. Temporary income and expenses increased our profit by JPY 8.7 billion from the previous fiscal year.
In FY 2021, we booked JPY 2.1 billion temporary income as gains related to sale of Osaka Logistics Center to TAIYO Pharma Tech. In FY 2022, we booked JPY 6 billion gains related to sales of subsidiary in China and JPY 3.2 billion gains on reversal related to the closure of Plexxikon. Financial income, expenses, et cetera, decreased our profit by JPY 5.6 billion year-on-year due to deterioration in Forex gains and losses, et cetera. Income taxes, et cetera, increased by JPY 9.5 billion year-on-year due to an increase in pre-tax profit. Also, tax rate increased as we book tax expenses by using the simplified method in our quarterly account settlement. As a result, profit attributable to owners of the company decreased by JPY 4.2 billion year-on-year to JPY 58.3 billion.
Pages eight and nine show revenue increase or decrease in JPY by business unit and major product in Japan. Earlier on page five, I explained the situation of each unit by excluding the Forex impact, but here we are showing the results, including the Forex impact. Next, let me explain our FY 2022 forecast. Please turn to page 11. As for revenue, we are expecting sales increase mainly from Enhertu, as well as increase by Forex impact. We are making an upward revision of our revenue forecast announced in April by JPY 100 billion to JPY 1.25 trillion. Regarding cost of sales, we are reflecting cost increase associated with revenue increase, as well as increase by Forex impact, while factoring in the improvement of COGS ratio by changes in the product mix. We are expecting an increase by JPY 10 billion.
SG&A expense is expected to rise by JPY 58 billion based on an increase in profit sharing with AstraZeneca due to sales expansion of Enhertu, as well as an increase by Forex impact. As for R&D expenses, we are forecasting an increase by JPY 17 billion, expecting an increase in cost sharing with AstraZeneca due to acceleration of the development of Enhertu, as well as an increase by Forex impact. We are making an upward revision of our core operating profit forecast by JPY 15 billion to JPY 120 billion. In FY 2022 second quarter, we booked gains related to sales of subsidiary in China, et cetera, as temporary income. Our operating profit forecast is revised upward by JPY 25 billion to JPY 130 billion.
In response to the upward revision of operating profit and pre-tax profit forecast, we are making an upward revision of our forecast of profit attributable to owners of the company by JPY 17 billion to JPY 100 billion. Our currency rate assumptions for the third and the fourth quarter is JPY 140 against the U.S. dollar and JPY 140 against the Euro. We expect that the yen's depreciation will have a Forex impact to increase our revenue by about JPY 30 billion and decrease our core operating profit by about JPY 17 billion vis-a-vis our original forecast announced in April. Next, I will talk about our business update. Page 13 shows a breakdown of Enhertu revenue.
FY 2022 second quarter year-to-date product sales increased to JPY 79.5 billion, up by JPY 52.8 billion year-on-year due to growth in U.S., Europe, and other regions. I will explain the performance in each region later. FY 2022 second quarter year-to-date regulatory milestone payment increased to JPY 16.8 billion, up by JPY 15.7 billion year-on-year with the approval of U.S. HER2-positive breast cancer second line in May this year, E.U. HER2-positive breast cancer second line in July, U.S. HER2-low breast cancer post chemotherapy in August, and U.S. HER2-mutant NSCLC second line in August. We booked a total of JPY 16.8 billion regulatory milestone. FY 2022 second quarter year-to-date Enhertu revenue, including upfront and regulatory milestone payments totaled JPY 101.9 billion, increasing by JPY 69.1 billion year-on-year.
Based on the good performance in the United States and Europe, we are making an upward revision of our FY 2022 forecast we announced in April by JPY 81.8 billion to JPY 241.7 billion, which includes JPY 14 billion regulatory milestone expected to be achieved in the current fiscal year.
Slide 14 shows Enhertu sales growth in the U.S. since its launch in the fourth quarter of FY 2019 on a quarterly basis. Steady market penetration and the addition of new indications have led to steady growth in product sales. In particular, the addition of new indications in the first and second quarters of FY 2022 has resulted in global revenue growth of more than 50% from the first quarter to nearly JPY 50 billion in the second quarter of FY 2022. From Slide 15, I will use two slides to explain the sales status of Enhertu in each region. The first is the sales status of Enhertu in the United States and Europe. Due to steady market penetration and the addition of new indications, sales of Enhertu in the U.S. and Europe are growing steadily.
In the U.S., product sales for the first half of FY 2022 totaled JPY 55.3 billion, or $413 million. Due to strong sales, we have revised our forecast announced in April to a JPY 137 billion, or $1 billion target for FY 2022, an increase of JPY 53.9 billion from the forecast announced in April. The current indications are as shown in this slide, but new indications were added in the second quarter, namely breast cancer with low HER2 expression previously treated with chemotherapy and second-line treatment of HER2-mutated lung cancer. Market share growth in each indication is also steady, with the new patient share of HER2-positive breast cancer second-line treatment, which we started promoting in May, growing to the 40% range, consolidating our leading position.
The most recent new patient share for the third line treatment of HER2-positive breast cancer was in the 30% range, still maintaining the top position in the market. Although we are not yet able to provide specific market share figures for HER2-low breast cancer patients previously treated with chemotherapy, which we began promoting in August, we are rapidly expanding prescriptions in the target market. Major progress in the second quarter includes the start of promotions in August to gain approval for chemotherapy pre-treated HER2-low-expression breast cancer and HER2 mutant NSCLC second-line treatment. We feel that the product strength of Enhertu is steadily being accepted by prescribing physicians. Sales in Europe are also on track, with product sales in the first half of FY 2022 totaling JPY 13.7 billion, or $102 million.
We have revised our April forecast for FY 2022 to JPY 30.1 billion, or $220 million in response to strong sales. In addition to the third-line treatment of HER2-positive breast cancer, the second-line treatment of HER2-positive breast cancer was added to the current indications in July this year. New patient share in the countries where the product has been launched is also steadily increasing and the most recent new patient share in the third-line treatment of HER2-positive breast cancer remains the top share in the U.K., France, and Germany. As a major progress in July this year, we obtained approval for the second-line treatment of HER2-positive breast cancer, and we have started promotion in some countries. Slide 16 shows sales of Enhertu in Japan and the ASCA region.
Due to steady market penetration and expansion of the countries and regions where Enhertu is launched, product sales of Enhertu in Japan and ASCA are growing steadily. Product sales in Japan for the first half of FY 2022 totaled JPY 5.2 billion. We aim to increase the sales to JPY 16 billion in FY 2022, with the addition of the second-line HER2-positive breast cancer indication scheduled for the second half of the year. The market share of the new patients for each indication is steadily expanding, with the market share of the third-line treatment of HER2-positive breast cancer remaining in the 40% range and the third-line treatment of HER2-positive gastric cancer expanding to the 60% range, achieving the top share in each of these indications.
Product sales in the ASCA region for the first half of FY 2022 totaled JPY 5.3 billion. Product sales in the ASCA region also include co-promotion revenues in Hong Kong, where AstraZeneca records sales. In response to strong sales, we revised the forecast announced in April to JPY 12.1 billion for FY 2022. Sales are expanding in Brazil, Hong Kong, and Taiwan, where the product was launched in April. We will continue our efforts to further penetrate the market in each region and expand the number of countries and regions where the product is launched, as well as to obtain new indications in order to deliver Enhertu to as many patients as possible in need of the drug.
On slide 17, we are pleased to announce that we have won the Pharma Company of the Year award at the Pharma Intelligence Awards 2022. This is the first time that the Pharma Intelligence Awards 2022, the Japanese version of the Scrip Awards, which have been held in the U.K. for 17 years and are known worldwide, has honored our company as the Pharma Company of the Year. The Pharma Company of the Year award recognizes outstanding performance by a pharmaceutical company during the year 2021. It's judged by the Scrip editorial staff based on various indicators such as sales, profits, and pipeline expansion. The award recognized our focus on oncology and the strength of our proprietary antibody drug conjugate, ADC platform, as well as Enhertu's efficacy in breast cancer and its broad potential for the future. Next is about Lixiana.
Slide 18 shows our market share in volume in each country. In addition to Japan, South Korea, and Taiwan, Lixiana is growing steadily in Belgium, Spain, Italy, and other European countries. As a result, global sales revenue for the second quarter of FY 2022 was JPY 117.3 billion, an increase of JPY 18.1 billion year-over-year. For FY 2022, we forecast full year revenue of JPY 242.1 billion, an increase of JPY 36.4 billion year-over-year. Slide 19 shows the market share of Lixiana in Japan in billions of yen. Although the sales share of Lixiana declined due to the reduction of the NHI reimbursement price in April 2020, as a result of the repricing for exceptional expansion, it has since increased its market share again, maintaining the top share at 41.4%.
As a result, cumulative sales revenue for the second quarter of FY 2022 was JPY 50.7 billion, an increase of JPY 5.9 billion from the same period last year. For FY 2022, we forecast full year revenue of JPY 106.6 billion, an increase of JPY 14.1 billion year-on-year. Next, I'd like to introduce our investments in our U.S. business. Please see slide 20. In August of this year, American Regent acquired HBT Labs, Inc. HBT Labs, Inc., based in California, USA, is a company with advanced formulation technologies and is engaged in the research, development, manufacturing, and marketing of generic injectable drugs, mainly in the field of oncology. Currently, HBT Labs, Inc. is marketing an authorized generic of the anti-cancer drug Abraxane, which is supplied by Bristol Myers Squibb.
In addition, HBT's proprietary generic Abraxane, which is paclitaxel, received FDA approval in July of this year and is scheduled for launch in the fourth quarter of this fiscal year. Other R&D items include generic injectable aripiprazole and bupivacaine. American Regent's mid to long-term growth will require further expansion of its iron deficiency anemia treatments as well as enhancement of its generic injectable product portfolio. The objective is to further strengthen the generic injectable pipeline, particularly in oncology, by combining HBT's advanced formulation technologies with paclitaxel's contribution to sales revenue and profit. The upfront payment of $225 million or JPY 30 billion has already been paid. Other milestones and royalty payments are scheduled to be made upon the launch of the R&D items, aripiprazole and bupivacaine. On slide 21, I will discuss other initiatives in each region.
The transformation to a profit structure centered on new drugs is progressively progressing steadily. In the U.S., we completed the transfer of eight products including Benicar, a drug for hypertension treatment, and recorded a gain of $22 million or JPY 3.2 billion on the transfer in the first half of the year. We plan to record a gain of $50 million in the second half of the year and $20 million in FY 2024 for a total gain on transfer of $57 million. In Europe, the transfer of the antiplatelet agent Effient progressed and a gain of EUR 18.7 million or JPY 2.7 billion was recorded in the first half. The remainder will be recorded upon completion of the transfer in Turkey, and the total gain from the transfer is expected to be EUR 20.5 million.
In ASCA, the transfer of the antibacterial agent Cravit and its subsidiaries in China was completed and the full amount of EUR 6 billion was recorded in the first half of the year. On slide 22, I'll give you a major update on our patent disputes. First, I'd like to discuss our dispute with Seagen regarding our ADCs. In August of this year, an arbitral tribunal ruled against Seagen's claims in its entirety. The arbitration decision rejected Seagen's claims and we will retain our intellectual property rights to the disputed ADC technology and continue to develop and commercialize our ADC products as we have planned. On the other hand, in July of this year, the United States District Court ruled that our Enhertu infringes Seagen's U.S. patents.
The court has not yet ruled on the payment of royalties on future sales of Enhertu during the term of Seagen's patent, which expires in 2024. We believe that the Court of Appeals will likely find Seagen's U.S. patents invalid, and we will continue to consider all legal options to protect our rights.
Next, regarding the dispute with Novartis regarding the Plexxikon patent. Plexxikon had filed a lawsuit in the U.S. Federal District Court in 2017, alleging that the Novartis BRAF inhibitor, Tafinlar, infringes on a U.S. patent owned by Plexxikon. In September of this year, the Federal District Court issued a decision upholding Plexxikon's claim. In response, Novartis appealed the District Court decision in October of this year. Slide 23 presents the revised annual dividend forecast. Enhertu, the most important pillar of our fifth midterm business plan, is expanding its sales more than expected. In conjunction with the upward revision of the full-year forecast for this fiscal year, we have decided to bring forward by one year the dividend increase that we had assumed for FY 2023 and beyond. To increase the dividend in line with profit growth from this fiscal year.
Specifically, the annual dividend forecast per share will be revised upward from JPY 27 to JPY 30 . Going forward, we will continue to improve capital efficiency and further enhancement of shareholders' returns, aiming to achieve a DOE of 8% or higher in FY 2025, which is a KPI of the fifth midterm business plan.
Next, R&D update. I'd like to hand over to R&D Division Head, Wataru Takasaki. Takasaki speaking. Today, I'm going to talk about our R&D update. First, an update on our three ADCs. Page 26 is Enhertu breast cancer update. Based on the encouraging results from DESTINY-Breast04 study we presented at ASCO in June, we were able to pioneer HER2-low breast cancer as a new clinically meaningful patient segment and demonstrate that Enhertu has the potential to become a standard of care.
In August, Enhertu was approved in the United States for HER2-low breast cancer previously treated with chemotherapy. Approval was granted swiftly after 11 days from filing acceptance under FDA's Breakthrough Therapy Designation, Priority Review, and the Real-Time Oncology Review Program. Enhertu has become the first HER2-directed therapy to demonstrate survival benefit in patients with HER2-low breast cancer, which accounts for about 50% of the entire breast cancer. FDA approved companion diagnostics in October. Regulatory submission is making steady progress in other countries and regions. In addition to the filing acceptance in Japan and Europe in June, filing was accepted in China in August. Aiming to provide new treatment options to more breast cancer patients in HER2-low breast cancer, we are implementing studies in chemotherapy-naïve patients, as well as studies to evaluate combination therapies with other anticancer agents. Please turn to page 27.
Enhertu is transforming the treatment of breast cancer patients with the approval for HER2-low breast cancer and establishing leadership in HER2-directed therapies. Development to expand this leadership position to other tumor types is also making steady progress. I would like to give you an update on lung cancer. In August, Enhertu was approved in the United States for HER2-mutant NSCLC in the second-line settings and beyond. This is the third tumor type approved for Enhertu following breast cancer and gastric cancer. This indication was approved under Breakthrough Therapy Designation, Priority Review, and Accelerated Approval Process based on the results of DESTINY-Lung02 interim analysis as well as DESTINY-Lung01 study. The approved dose is 5.4 mg/ kg. Along with the approval of Enhertu for NSCLC, FDA approved two types of companion diagnostics as well.
In September, in Japan, Enhertu was granted orphan drug designation for unresectable, advanced, or recurrent HER2-mutant NSCLC. Filing is planned in Japan and Europe in the second half of the current fiscal year. Aiming to obtain approval for early treatment of HER2-mutant NSCLC and expand the countries and regions with approval, DESTINY-Lung04 study is ongoing globally in the first-line settings right now. In August, in China, we initiated DESTINY-Lung05 study in the second-line settings and beyond. On page 28, I'd like to show you DESTINY-Lung02 study interim analysis data we presented at ESMO last month. This is an excerpt of data which shows that Enhertu 5.4 mg/kg can be the first HER2-directed therapy for treatment of patients with HER2-mutant NSCLC, and which also supported FDA approval. Let me explain some details of the study and the data.
DESTINY-Lung02 study is a comparative study of 5.4 mg/kg and 6.4 mg/kg Enhertu in patients with previously treated HER2 mutant NSCLC. ORR was 53.8% with 5.4 mg/kg and 42.9% with 6.4 mg/kg at the time of the interim analysis. ORR was 57.7% with 5.4 mg/kg after additional 90-day follow-up response analysis. No new safety concerns were identified. Based on the balance between efficacy and safety, 5.4 mg/kg was judged to be the optimal dose. We are now accelerating our development to expand countries and regions with NSCLC approval and obtain the indication for early treatment so that we can deliver Enhertu to more patients. From page 29, I will talk about Dato-DXd update.
At WCLC 2022 in August, we presented TROPION-Lung02 study data for the first time. This is a study evaluating the efficacy and safety of Dato-DXd plus pembrolizumab doublet or Dato-DXd plus pembrolizumab plus platinum chemotherapy triplet for relapsed and advanced NSCLC without actionable genomic alterations, regardless of PD-L1 expression level. Each cohort consists of dose confirmatory and dose expansion studies. First-line patients with no prior therapy are enrolled in cohort 3 through six dose expansion studies. Primary endpoint is safety and tolerability. As secondary endpoints, ORR, DOR, duration of therapy, PFS, OS are also evaluated. Next, on page 30, I'm showing you the interim analysis data from this study. Encouraging interim analysis data in terms of efficacy and safety was obtained overall and for previously untreated first-line patients.
ORR was 62% for doublet and 50% for triplet respectively in first-line patients, and responses were observed across all levels of PD-L1 expression. Overall safety was consistent with Dato-DXd monotherapy, and no grade 4 or 5 ILD events were adjudicated as drug-related. We are now conducting phase III TROPION-Lung08 study to evaluate the efficacy and safety of Dato-DXd plus pembrolizumab combination therapy for PD-L1 50% or higher first-line NSCLC without actionable genomic alterations. TROPION-Lung 02 interim analysis data suggests efficacy in patients with a PD-L1 under 50%. We plan to initiate a new study shown on the next page. Please turn to page 31. Let me explain TROPION-Lung07 study we are planning to initiate. This is a new phase III study to evaluate the combination of Dato-DXd and pembrolizumab in first-line patients with PD-L1 under 50% non-squamous NSCLC without actionable genomic alterations.
We are planning to initiate this study in the second half of the current fiscal year. This is a comparative study with three arms, Dato-DXd plus pembrolizumab doublet, Dato-DXd plus pembrolizumab plus platinum chemotherapy triplet, and pembrolizumab plus pemetrexed plus platinum chemotherapy as a control arm. Primary endpoint is PFS and OS. We will also evaluate ORR, DOR, et cetera, as secondary endpoints. The status of Dato-DXd phase 3 development in NSCLC is shown in the left bottom for your reference. Taking advantage of the broad expression of Trop-2, which is Dato-DXd's target, we are accelerating the development in tumor types other than lung and breast cancer, where phase III studies are ongoing. As part of such efforts, in September, we initiated TROPION-PanTumor03 study, which is a phase II exploratory study in multiple types of solid cancer.
Slide 32 shows the newly initiated clinical studies for HER3-DXd. As shown on the lower left, since last February, we have been conducting the HERTHENA-Lung01 study, a phase II study for submission for the third-line treatment of NSCLC with EGFR mutation. In addition, the HERTHENA-Lung02 study for second-line treatment after tyrosine kinase inhibitor treatment was newly initiated in August. This is a two-arm comparative study of HER3-DXd alone or in combination with pemetrexed and a platinum-based agent. The primary endpoint is PFS and OS. ORR, et cetera, will be confirmed as secondary endpoints. Slide 33 and after are an update on ADCs. Please see slide 34. First of all, I'd like to present the progress of DS-7300, one of the rising stars of the project, which we expect to be the next growth driver after three ADCs.
Over the next two slides, I will present the interim analysis data from the phase 1/2 study of DS-7300, which was presented at ESMO in September. The study investigates a variety of cancer types, including small cell lung cancer, SCLC, castration-resistant prostate cancer, mCRPC, squamous cell NSCLC, and esophageal squamous cell carcinoma. An interim analysis showed early efficacy in patients with a variety of cancer types who had received multiple prior treatments. The confirmed ORR for all eligible patients, regardless of cancer type, was 28%. Safety trends were consistent with previous reports, and no new concerns were identified. The next slide 35, shows data on antitumor efficacy by cancer type. The confirmed ORR was 53% for SCLC, 28% for mCRPC, 40% for squamous cell NSCLC, and 18% for esophageal squamous cell carcinoma.
A phase II study is already underway in SCLC since June of this year. Based on the data from this study, we are accelerating development in SCLC. In addition, we will continue development in other types of cancer with the aim of providing a new treatment option for patients with multiple types of cancer for whom treatment options are limited. Continuing to slide 36, which shows the progress of DS-5670, the COVID-19 vaccine. First, I'd like to discuss the development of a booster vaccine. We plan to obtain the top-line results of part two of the phase 1/2/3 study, which aims to verify the non-inferiority of DS-5670 to the approved COVID-19 messenger RNA vaccine in the third quarter of this fiscal year. Partial data has already been submitted to the PMDA since September of this year using the pre-assessment consultation system.
As soon as the results of this study are finalized, we plan to submit an application for approval in FY2022. We have also started consultation with the PMDA on a development plan for a bivalent vaccine compatible with the Omicron variant in order to advance its development. Next, I'd like to discuss the progress of the development of the primary vaccination. In September of this year, we initiated phase III study in adults in Japan. We will continue our efforts to commercialize domestically produced messenger RNA vaccines and to establish manufacturing technology for them, aiming for a rapid response to emerging and re-emerging infectious diseases in the future. Slide 37 presents the trial process and approval status of other assets. In September, valemetostat, an EZH1/2 inhibitor, was approved in Japan for the treatment of adult T-cell leukemia/lymphoma.
In August, the applications for quizartinib for the primary treatment of acute myeloid leukemia with FLT3-ITD mutation were accepted for review in Europe and Japan, and in October in the United States. Approval is expected in the next fiscal year. A phase II study of VN-0200, an RSV vaccine, was also initiated in Japan in October for healthy elderly subjects. Next is the announcement of the R&D Day. As noted on slide 39, we will hold another R&D Day in December this year. The time and date is December 13th from 7:30 to 9:00 A.M. Japan time. Manabe and Takeshita will be speaking, and the event will be held virtually. Please join us and watch the program. From slide 40 is the news flow for upcoming events. Please see slide 41.
At the San Antonio Breast Cancer Symposium starting December sixth local time, we will report Enhertu's efficacy and safety updates, including OS from the DESTINY-Breast03 study. For Dato-DXd, we will present the first data from the TROPION-PanTumor01 study in hormone receptor-positive, HER2-negative breast cancer. Additionally, we will update the TNBC data. We will also update our data on BEGONIA study, a combination study with durvalumab for the primary treatment of TNBC. Other information includes expected future approvals, planned regulatory filings, expected availability of key data, and expected timing of pivotal study initiation. Please note that the timelines shown are current estimates and are subject to change. Slide 42 onwards is the appendix. Please check back later for a list of milestones and pipeline. That is all for my presentation. We will now take your questions. Thank you very much for your cooperation.
Now we'd like to move on to a Q&A session with investors and analysts. If you have questions, please. First, Mr. Yamaguchi from Citigroup Securities.
Hello, can you hear me?
Yes, we can hear you. Thank you.
I have two questions. First, about the trend of new indications of Enhertu. Sales of HER2-low and NSCLC have already started. You talked about rapid penetration but did not mention market share. Could you please comment on the pace of penetration if possible? This is my first question.
Manabe would like to respond.
These indications have been approved just recently. It has been making a good start. Other than that, we cannot show you specific numbers yet. We would appreciate it if you could wait for some more time. Companion diagnostics have been approved later.
Do you think there are no issues in identifying eligible patients?
No problem. We used the conventional ones during the studies and now have additional ones. We are proceeding without any issue.
Okay, understood. Secondly, I'd like to ask you about your midterm business plan. Your midterm business plan is in progress towards FY 2025 or 2026.