Tag: Everest Medicines

Everest Medicines (HKEX 1952.HK, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the first prescription for VELSIPITY(R) has been written at Foshan Fosun Chancheng Hospital in Guangdong, under the “Hong Kong and Macau Medicine and Equipment Connect” policy, which marks the official beginning of this new therapy benefiting patients in mainland China. 

VELSIPITY(R) is an innovative advanced therapy that was approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is an oral treatment taken once daily for the treatment of patients aged 16 and above with moderately to severely active ulcerative colitis (UC). UC is a chronic, relapsing, non-specific inflammatory disease, and as the disease progresses, the risk of disability and colorectal cancer incidence continues to rise. By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies.  

Professor Wu Ji, Director of the Gastroenterology Department at Foshan Fosun Chancheng Hospital said, “We are very happy to see that VELSIPITY(R) has been prescribed in our hospital through the ‘Hong Kong and Macau Medicine and Equipment Connect’ policy. With a large population of UC patients in the Guangdong province and high clinical demand, this is a significant milestone. As the only drug that has been proven to be effective in isolated proctitis in global Phase III clinical trials, VELSIPITY(R) is an oral treatment taken once daily with a favorable safety profile, providing an innovative treatment option for patients who have long been troubled by UC. We look forward to Everest Medicines further enhancing the accessibility of VELSIPITY(R) to benefit more Chinese patients in the future.”

As a core product of Everest Medicines, VELSIPITY(R) can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In the results of the Asian multi-center Phase 3 clinical trial of VELSIPITY(R) for the treatment of moderately to severely active UC announced in July this year, VELSIPITY(R) achieved positive topline data results in both the induction and maintenance treatment periods, providing further solid scientific basis and support for the wide application of the drug in clinical practice. 

In this October, through the “Hong Kong and Macau Medicine and Equipment Connect” policy, VELSIPITY(R) has officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and can be used in the medical institutions designated by the Connect Policy in the Greater Bay Area, including First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Healthcare. Also, with the recent inclusion in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, VELSIPITY(R) is expected to accelerate its availability in all 45 designated medical institutions under the Connect Policy.

About VELSIPITY(R) (etrasimod)

VELSIPITY(R) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau for VELSIPITY(R) in ulcerative colitis.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Everest Medicines (HKEX 1952.HK, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the National Medical Products Administration (NMPA) of China has officially accepted the New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of patients with moderately to severely active ulcerative colitis (UC). VELSIPITY(R) is an effective and convenient, once-daily, oral treatment for patients with moderately to severely active UC.

VELSIPITY(R) was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024, and was introduced in the Greater Bay Area in October through the “Hong Kong and Macau Medicine and Equipment Connect” policy. VELSIPITY(R) is now the third commercialized product of Everest Medicines.

“We are pleased to see that the NDA for VELSIPITY(R) has been officially accepted in mainland China., “said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “If approved, China would represent the third approval of VELSIPITY(R) in Everest’s licensed territories for the drug after Macau and Singapore. By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies. We are committed to expanding access to VELSIPITY(R), with the goal of benefiting more patients living with moderately to severely active ulcerative colitis. “

” As the only drug that has been proven to be effective in UC patients with moderately to severely active isolated proctitis in global Phase III clinical trials, the official acceptance of the NDA for VELSIPITY(R) in mainland China brings hope to many patients,” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial.” As a next-generation S1P receptor modulator, VELSIPITY(R) can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief. In addition, the data from the largest-scale Phase III clinical trial of moderately to severely active UC patients in Asia once again confirmed the favorable efficacy and safety profile of VELSIPITY(R). We look forward to the early approval of this drug to benefit more patients.”

As a key product for Everest Medicines, VELSIPITY(R) was approved in Macau, China and Singapore in the first half of this year. Its first prescription has been issued on December 11th at Kiang Wu Hospital in Macau, which marks the official beginning of this new therapy benefiting patients across Asia. In addition, Everest Medicines has also submitted and had its NDA officially accepted for VELSIPITY(R) in Hong Kong. With the support of the “Hong Kong and Macau Medicine and Equipment Connect” policy, VELSIPITY(R) has also been officially approved to enter the Greater Bay Area and can be used in four designated medical institutions which are the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Hospital.

VELSIPITY(R) has been recently included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area (“the Catalog”), published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. With the inclusion of VELSIPITY(R) in the Catalog, we expect to accelerate its availability in all 45 designated medical institutions under the Connect Policy.

About VELSIPITY(R) (etrasimod)
VELSIPITY(R) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY(R) in ulcerative colitis.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

• Officially Beginning to Benefit Asian Patients

Everest Medicines (HKG: 1952, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that the first prescription of VELSIPITY(R) (etrasimod) has been issued on December 11th at Kiang Wu Hospital in Macau. It is also the first prescription issued for VELSIPITY(R) within Everest Medicines’ licensed territories in Asia following its approval, marks the official beginning of this new therapy benefiting patients across Asia.

VELSIPITY(R) is an innovative advanced therapy that was officially approved by the Pharmaceutical Administration Bureau of Macau in April 2024. It is an oral treatment taken once daily for the treatment of patients aged 16 and above with moderately to severely active ulcerative colitis (UC). UC is a chronic, relapsing, idiopathic inflammatory disease, and with prolonged disease duration, the risk of disability and colorectal cancer incidence continues to rise.

“As a next-generation S1P receptor modulator, VELSIPITY(R) can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief.” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU, the principal investigator for etrasimod’s Asia clinical trial.” The recently announced results of the Asian multicenter Phase III clinical study for induction and maintenance periods further confirm the clinical advantages of VELSIPITY(R). We look forward to VELSIPITY(R) being approved in other regions of Asia soon to benefit more patients.”

“The first prescription of VELSIPITY(R) in Macau marks another milestone in the commercialization process of Everest Medicines.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.” By 2030, the number of patients with UC in China is expected to more than double compared to 2019, reaching approximately 1 million, with a significant unmet need for innovative therapies. Following its approval in Macau this April, VELSIPITY(R), the third commercialized product of Everest Medicines, will bring new treatment options to more patients with moderate to severely active UC. We plan to have VELSIPITY(R) submitted for new drug application in mainland China by the end of this year, further enhancing its accessibility and benefiting more patients.”

In the results of the multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of subjects with moderately to severely active UC, which were announced in July this year, etrasimod achieved positive results in both the induction and maintenance phases of treatment, with good safety, and the convenience of once-daily oral administration, further providing a solid scientific basis and support for the broad application of the drug in clinical practice. In October, the complete induction phase data of the study were presented at the 32nd United European Gastroenterology Week (UEGW 2024), showing that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group at week 12: the treatment differences between the etrasimod group and the placebo group in clinical remission rate, endoscopic improvement rate, and clinical response rate reached 20.4%, 28.6%, and 32.0%, respectively.

VELSIPITY(R) was approved in the United States and the European Union in October last year and February this year, respectively. As a core product for Everest Medicines, VELSIPITY(R) was successively approved in Macau and Singapore in the first half of this year. Everest Medicines has also submitted a new drug application for VELSIPITY(R) in Hong Kong, China which has been officially accepted.

In October of this year, through the “Hong Kong and Macau Medicine and Equipment Connect” policy, VELSIPITY(R) has officially been approved for patients with moderately to severely active ulcerative colitis (UC) by the Guangdong Provincial Medical Products Administration and can first be used in the First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University and Guangzhou United Family Healthcare, four of the medical institutions designated by the Connect Policy in the Greater Bay Area. Subsequently, VELSIPITY(R) will be introduced in other qualified hospitals under the connect policy.

About VELSIPITY(R) (etrasimod)
VELSIPITY(R) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau for VELSIPITY(R) in ulcerative colitis.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

– Patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission.
– In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved immunological complete remission by week 24.
– EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported.

Everest Medicines (HKG 1952,Everest, or the Company),  a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of primary membranous nephropathy (pMN) with EVER001 (previously known as XNW1011), a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor. In an analysis of the data available as of September 13th, 2024, results from the Phase 1b/2a clinical trial showed that for patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission1 and 10 out of 11 (91%) achieved immunological complete remission (ICR)2. In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24.

EVER001 is a covalent reversible BTK inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases.

The Phase 1b/2a clinical trial of EVER001 for the treatment of pMN is an ongoing trial conducted in China. A total of 31 patients with biopsy-proven pMN who tested positive for anti-PLA2R autoantibodies were enrolled into two cohorts. The total treatment duration was 36 weeks. Based on the patient data collected by September 13th, 2024, in the low-dose cohort, the geometric least squares mean 24-hour proteinuria decreased by 78.3% at week 36 compared to baseline, while the high-dose cohort achieved a 73.8% reduction by week 24. EVER001 treatment induced greater than 90% reductions in anti-PLA2R antibody as early as week 24 in the low-dose cohort and week 12 in the high-dose cohort. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported.

“We are excited to see the encouraging results in this preliminary analysis of our Phase 1b/2a clinical proof-of-concept trial of EVER001. This demonstrates the potential of EVER001 as a next-generation BTK inhibitor for the treatment of various autoimmune renal diseases, including pMN. “Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines, said：”This data release marks the first time Everest Medicines has disclosed results from its global pipeline. We look forward to completing this trial and sharing detailed data in future conferences and publications. Moving forward, we will continue to drive the global clinical development of EVER001, to meet patients’ urgent clinical needs.”

Membranous nephropathy is a common pathological type of nephrotic syndrome in adults, and its prevalence in China has been increasing, ranking second only to IgA nephropathy3. There are about 2 million patients with pMN in China, with an estimated 80,000 to 100,000 patients in the United States, 80,000 in Europe, and 40,000 in Japan. There are no approved drugs for this indication worldwide. The current treatment goal is to improve remission rates, reduce high relapse rates, and minimize the risk of chronic toxicity caused by currently available treatments. More than one-third of pMN patients still progress to end-stage renal disease under current standards of care.

This Phase 1b/2a clinical trial was approved by the Center for Drug Evaluation of the National Medical Products Administration in September 2022 to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of EVER001 in Chinese patients with glomerular diseases characterized by proteinuria. The previously published results of a Phase 1 study conducted in healthy Chinese and Australian subjects conducted by SinoMab BioScience indicate that EVER001 has high selectivity, excellent pharmacokinetic properties, a good safety profile, and strong target binding.

About EVER001

EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. Based in part on results from a completed phase 1 trial with healthy subjects conducted by SinoMab in China, EVER001 exhibited high selectivity, excellent pharmacokinetics properties, strong target binding and a safety profile that supports continued clinical development.

Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases.

Investor Calls Information

Everest Medicines will hold investor calls on the data results from EVER001 Phase 1b/2a clinical study in primary membranous nephropathy. EVER001 is a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor, and Everest owns the global rights to develop EVER001 for the treatment of renal diseases.

The English session of the conference call will be held at 9:00 AM on Dec. 4, 2024, Beijing Time (8:00 PM U.S. Eastern Time on Dec. 3, 2024) and the Mandarin session of the conference call will be held at 10:30 AM Beijing Time on the same day (9:30 PM U.S. Eastern Time on Dec. 3, 2024).

The conference calls can be accessed by the following links:
For English Session:
Time: 9:00 AM Beijing Time, Wednesday, Dec. 4, 2024 (8:00 PM U.S. Eastern Time on Dec. 3, 2024)
Pre-Registration Link: https://www.acecamptech.com/eventDetail/60510700
Webcast Link:
https://www.acecamptech.com/meeting_live/70512679/774680?event_id=60510700
Alternatively, participants may dial in to the conference call using below dial-in information:
United States: +1-646-2543594 (EN)
Chinese Mainland: +86-10-58084166 (EN), +86-10-58084199 (CN)
Hong Kong, China: +852-30051313 (EN), +852-30051355 (CN)
United Kingdom: +44-12-1368-0466 (EN)
International: +1-866-6363243 (EN)
Password: 842080

For Mandarin Session:
Time: 10:30 AM Beijing Time, Wednesday, Dec. 4, 2024 (9:30 PM U.S. Eastern Time on Dec. 3, 2024)
Webcast Link: https://s.comein.cn/n3arj55s
Alternatively, participants may dial into the conference call using below dial-in information:
United States: +1-646-3578788, +1-408-7093255
Chinese Mainland: 400-969-8928, 400-806-3263
Hong Kong, China: +852-301-83602
Taiwan, China: +886-226563394, +886-277417882
Singapore: +65-64075649, +65-66220840
United Kingdom: +44-2070970018
International: +86-2362737123
Password: 377570

The replay of English session will be available shortly after the call and can be accessed by visiting the Company’s website at http://www.everestmedicines.com.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

References:

1.Overall clinical remission (complete remission or partial remission): 24h proteinuria complete remission (CR): 24h proteinuria < 0.3g/24 h; 24h proteinuria partial remission (PR): 24h proteinuria < 3.5g/24h, but ≥0.3g/24 h, and reduction > 50%, regardless of eGFR or the serum albumin level from baseline.
2. Immunological complete remission (ICR): anti-PLA2R titer < 20RU/ml (negative).
3. Expert consensus on the application of rituximab in the treatment of membranous nephropathy, Chin J Intern Med, March 2022, Vol. 61, No. 3.

Everest Medicines (HKG: 1952, Everest, or the Company), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative therapeutics, today announced that Department of Health of the Government of the Hong Kong Special Administrative Region, China, has accepted Everest’s New Drug Application (NDA) for VELSIPITY(R) (etrasimod) for the treatment of adult patients with moderately to severely active ulcerative colitis.  VELSIPITY(R) is an effective and convenient, once-daily, oral treatment for patients with moderately-to-severely active UC that has already been approved in the U.S. and E.U., and other countries, by Everest’s licensing partner, Pfizer. In Everest territories, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China has approved the NDA for VELSIPITY(R) in April of this year and was implemented in the Guangdong-Hong Kong-Macau Greater Bay Area this October through the “Hong Kong and Macau Medicine and Equipment Connect” policy.

“Autoimmune disease is a core focus and a significant growth driver for our company. The number of UC patients in China is projected to double from 2019 to 2030 to approximately one million, highlighting the urgent need for novel treatments.” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Previously, VELSIPITY(R) has already been approved in Macau, China, and was implemented in the Greater Bay Area through the connect policy. The company also plans to submit the NDA for approval by China’s National Medical Products Administration (NMPA) this year, with the aim of benefiting more Chinese patients as soon as possible.”

” This is an important advancement for etrasimod, bringing hope to patients in Hong Kong, China. This new-generation S1P receptor modulator is an oral, once-daily treatment that can provide patients with a chance for corticosteroid-free remission, mucosal healing, and rapid symptom relief, ” said Prof. Wu Kaichun with the First Affiliated Hospital of AFMU who is the principal investigator for etrasimod’s Asia clinical trial. “We hope China and other Asian countries can obtain approvals as soon as possible to benefit more patients.”

The acceptance of the NDA was based on results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once-daily on clinical remission in UC patients with moderately to severely active UC who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12 were naïve to biologic or JAK inhibitor therapy, and these studies were also the only studies for advanced therapies for ulcerative colitis to include patients with isolated proctitis. Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of etrasimod.

Everest conducted a multicenter, randomized, double-blind and placebo-controlled Phase 3 trial of etrasimod in Asian countries, including mainland China, China Taiwan and South Korea. This is the largest Phase 3 trial of moderately-to-severely active ulcerative colitis in Asia completed to date, with 340 eligible subjects randomized to treatment with etrasimod or placebo. The previously announced results of the induction period indicate that the clinical remission rate for patients treated with etrasimod 2mg was 25.0%, compared to 5.4% for those treated with placebo (difference 20.4%, p<0.0001). Compared to the placebo group, patients treated with etrasimod demonstrated significant clinical and statistically significant improvements in all key secondary endpoints. Subsequently, the topline results from maintenance period released in July of this year confirmed that after 40 weeks of treatment, etrasimod demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of etrasimod was consistent with previous studies, with no new safety signals observed. The results of the maintenance period will be released at an international academic conference.

About VELSIPITY(R) (etrasimod)
VELSIPITY(R) is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5. Regulatory approvals have been granted in US, EU, Canada, Australia, Singapore, UK, Switzerland, Israel and Macau, China for VELSIPITY(R) in ulcerative colitis.

About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.