[Translation] An open-label phase I clinical trial comparing the pharmacokinetics, safety, and pharmacodynamics of a single oral dose of HSK39297 tablets in subjects with severe hepatic impairment and those with normal hepatic function.

主要目的：比较HSK39297片在肝功能正常受试者和重度肝功能不全受试者中的药代动力学特征；次要目的：评价HSK39297片在肝功能正常受试者和重度肝功能不全受试者中的安全性；探索性目的：评价HSK39297片在肝功能正常受试者和重度肝功能不全受试者中的药效动力学特征。

[Translation]

Primary objective: To compare the pharmacokinetic characteristics of HSK39297 tablets in subjects with normal hepatic function and subjects with severe hepatic impairment; Secondary objective: To evaluate the safety of HSK39297 tablets in subjects with normal hepatic function and subjects with severe hepatic impairment; Exploratory objective: To evaluate the pharmacodynamic characteristics of HSK39297 tablets in subjects with normal hepatic function and subjects with severe hepatic impairment.

Start Date09 Apr 2026

Sponsor / Collaborator

Tibet Haisco Pharmaceutical Co. Ltd.

NCT07390123

/ RecruitingPhase 3

A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Start Date07 Apr 2026

Sponsor / Collaborator

Haisco Pharmaceutical Group Co., Ltd.

NCT07363460

/ RecruitingPhase 2

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Lupus Nephritis

A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis

Start Date18 Nov 2025

Sponsor / Collaborator

Haisco Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Ciprocopan

100 Translational Medicine associated with Ciprocopan

100 Patents (Medical) associated with Ciprocopan

Literatures (Medical) associated with Ciprocopan

01 Jul 2025·CTS-Clinical and Translational Science

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of HSK39297 in Chinese Healthy Subjects: A Phase 1 Clinical Trial

Article

Author: Ying Han ; Xiaojun Hu ; Meixia Chen ; Ying Jiao ; Laichun Lu ; Yunfei Lin ; Siyang Ni ; Lingling Wang ; Feng Wu ; Qinghe Wu ; Chao Wang ; Huan Lu ; Yuyang Dai ; Yilin Liu ; Fangqiong Li

ABSTRACT:

HSK39297 is a novel complement factor B inhibitor, and this phase 1 trial was designed to assess its pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability in healthy Chinese subjects. This study included 46 subjects in the single ascending dose (SAD) part (50–600 mg) and 50 subjects in the multiple ascending dose (MAD) part (50–125 mg BID and 200–300 mg QD). Among them, a food effect study was conducted in the SAD 200 mg group. Adverse events (AEs) reported after the initial dose of the study drug were considered treatment‐emergent AEs (TEAEs). Blood samples were collected to measure plasma concentrations of HSK39297 at predefined time points and analyzed at a centralized laboratory. In addition, PD analysis was conducted by measuring complement alternative pathway (AP) activity and Bb concentrations. According to the results, we found single and multiple doses of HSK39297 were safe and well tolerated in all subjects. Within SAD of 50–600 mg dose range, the Cmax , AUC 0‐ t , and AUC 0‐∞ exhibited nonlinear PK characteristics. The high‐fat meals did not significantly affect the absorption rate and systemic exposure levels of HSK39297, and GMRs for fed versus fasting states were 108.05% (99.66%, 117.15%), 98.73% (89.34%, 109.09%), and 97.86% (84.66%, 113.11%), respectively. In MAD part, dose‐drug exposure showed a linear relationship. PD analysis indicated that oral administration of HSK39297 tablets resulted in dose‐dependent inhibition of the AP activity and Bb concentration. These findings support advancing HSK39297 into later‐phase trials for complement‐mediated glomerular diseases.

News (Medical) associated with Ciprocopan

24 Jul 2026

·www.prnewswire.com

Haisco's Class 1 Innovative Drug Ciprocopan Succinate Tablets Approved in China, Offering a New Treatment Option for Patients With PNH

July 23, 2026 -- Haisco Pharmaceutical Group claimed today their independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets (development code: HSK39297), has received marketing approval from the National Medical Products Administration of China (NMPA) for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are complement-inhibitor-naïve. This is Haisco's fifth innovative drug approved for marketing and represents an important advance in the treatment of complement-mediated diseases in China. As the world's first once-daily oral complement factor B (FB) inhibitor, Ciprocopan Succinate Tablets offers patients with PNH a new, safe and convenient treatment option. Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired clonal disorder of hematopoietic stem cells. The disease is primarily characterized by intravascular hemolysis, bone marrow failure, and venous thrombosis. Ongoing hemolysis may cause fatigue, renal impairment, pain, dyspnea, and other symptoms. Studies have shown that, before complement inhibitors became available, patients with PNH had a poor prognosis. Conventional management of PNH primarily includes supportive care, prevention and treatment of thrombosis, and allogeneic hematopoietic stem cell transplantation; immunosuppressive therapy may be used in patients with concomitant bone marrow failure. According to the Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition), treatment of PNH should be based on clinical subtype, and complement inhibitors are recommended as first-line therapy for classic PNH. Although advances in complement-targeted therapies have improved the treatment of PNH in recent years, patient needs remain largely unmet. C5 inhibitors can control intravascular hemolysis but do not block upstream complement activation. Some patients continue to experience residual anemia, fatigue, or a need for transfusions. Traditional twice-daily dosing regimens carry a risk of breakthrough hemolysis. Patients need new therapies that are effective, convenient, and suitable for long-term disease management. Ciprocopan Succinate Tablets is a highly potent and selective small-molecule complement factor B (FB) inhibitor developed independently by Haisco with full intellectual property rights. Using a structure-based approach, Haisco's R&D team identified opportunities for optimization and incorporated metabolically stabilizing groups to shield metabolic soft spots at the source. By targeting a key step in the alternative complement pathway, the compound inhibits both pathway initiation and the alternative-pathway-mediated amplification loop, thereby suppressing activation of the complement system and delivering therapeutic efficacy in complement-mediated diseases. As an innovative oral small-molecule therapy, Ciprocopan Succinate Tablets is administered once daily. No dosage adjustment is required in patients with mild or moderate renal impairment or in patients with mild, moderate, or severe hepatic impairment. No dosage adjustment is required when the product is coadministered with strong CYP2C8 inhibitors, and it may be taken without regard to food, improving treatment convenience and adherence. Innovation is a core pillar of Haisco's strategy. From project initiation through clinical development, and from scientific exploration to successful commercialization, Ciprocopan Succinate Tablets represents a major milestone in Haisco's sustained investment in R&D and innovation. Guided by its innovation and globalization strategy and supported by the strong innovation ecosystem and biopharmaceutical industry environment in Sichuan Province and Chengdu, Haisco continues to increase investment in innovation. The company has built an R&D team of more than 1,000 professionals focused on key therapeutic areas, including anesthesia and pain management, chronic and metabolic diseases, gastrointestinal and liver diseases, respiratory diseases, autoimmune diseases, and oncology. Annual R&D investment has exceeded RMB 1 billion for several consecutive years, accelerating the translation of innovation into products. Haisco Pharmaceutical Group has established 5 modern manufacturing sites and more than 30 production lines across China to accelerate the industrialization of its innovative products. The Group has 27 Class 1 innovative drug programs and has established a tiered R&D pipeline spanning preclinical research and Phase I, Phase II, and Phase III clinical trials. Four Class 1 innovative drugs—Cipepofol Injection, Anrikefon, Cofrogliptin, and Crisugabalin—have received marketing approval, all of which are included in China's National Reimbursement Drug List (NRDL). Cipepofol Injection, an innovative intravenous anesthetic with independent intellectual property rights, received marketing approval from the U.S. Food and Drug Administration (FDA) in late May of this year. It is the first China-originated intravenous anesthetic new drug to enter the global market, marking a breakthrough from "new in China" to "new for the world". The successful approval and launch of Ciprocopan Succinate Tablets marks another breakthrough for Haisco in the frontier of global innovation in complement-mediated disease treatment and further enhances the company's innovative medicine portfolio. Haisco is advancing its Innovation and Globalization Strategy 2.0, expanding its presence in global innovation markets, and continuously strengthening its international clinical development and global collaboration capabilities. Ciprocopan Succinate Tablets is also a key program in Haisco's globalization strategy. In June 2026, Haisco entered into an Exclusive License Agreement with U.S.-based Nuvectis Pharma, Inc., granting Nuvectis exclusive rights to develop, manufacture, and commercialize HSK42360 (a BRAF inhibitor) globally outside Greater China, as well as exclusive rights to develop, manufacture, and commercialize HSK39297 (the ciprocopan succinate program) globally outside Greater China, Southeast Asia, and India. As part of the consideration for the out-license transaction, Haisco will receive license payments for the HSK42360 and HSK39297 programs, including a total of $40 million in upfront and near-term milestone payments and up to $1.421 billion in additional milestone payments. Haisco will also be eligible to receive tiered royalties of up to double-digit percentages on future net product sales. Together, the companies will work to make these products available to more patients worldwide. In recent years, Haisco has accelerated its globalization efforts and entered into innovative drug R&D collaborations and international licensing agreements with several global pharmaceutical companies, including AbbVie, Eli Lilly, and Nuvectis, across key areas such as oncology and autoimmune diseases. These collaborations are helping bring China-originated innovative medicines to international markets. China's innovative drug R&D capabilities are gaining increasing global recognition. Looking ahead, Haisco will continue to pursue its innovation and globalization strategy, focus on major disease areas and unmet clinical needs, accelerate the development and global expansion of original innovative medicines, and further strengthen its independent innovation capabilities. The company aims to build an internationally competitive portfolio of innovative medicines, bring more China-originated therapies to patients worldwide, and contribute to the Healthy China initiative and global biopharmaceutical innovation. Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired clonal disorder of hematopoietic stem cells. Acquired PIGA mutations in hematopoietic stem cells cause deficiencies in complement-regulatory proteins, including CD55 and CD59, and constitute the principal molecular basis of complement-mediated intravascular hemolysis in PNH. PNH is primarily characterized by intravascular hemolysis, bone marrow failure, and venous thrombosis. Ongoing hemolysis may cause fatigue, renal impairment, pain, dyspnea, and other symptoms. Studies have shown that, before complement inhibitors became available, patients with PNH had a poor prognosis. Conventional management of PNH primarily includes supportive care, prevention and treatment of thrombosis, and allogeneic hematopoietic stem cell transplantation; immunosuppressive therapy may be used in patients with concomitant bone marrow failure. According to the Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition), treatment of PNH should be based on clinical subtype, and complement inhibitors are recommended as first-line therapy for classic PNH. Enabled by deuterium substitution technology, Ciprocopan Succinate Tablets delivers three major advances in clinical benefit for PNH. A head-to-head Phase III study in China showed a hemoglobin target-attainment rate of 59.5%, a hemoglobin increase of 48.35 g/L, and reduced transfusion requirements; 94.6% of patients were transfusion-free, helping conserve healthcare resources. The incidence of treatment-emergent adverse events (TEAEs) was lower, and no adverse events led to treatment discontinuation or study withdrawal; the product also offers convenient once-daily oral dosing and a prolonged half-life of 21–38 hours. Results from two Phase III clinical studies of Ciprocopan Succinate Tablets were accepted for presentation at the 2026 Congress of the European Hematology Association (EHA). One was a randomized controlled study in patients with PNH who were complement-inhibitor-naïve, and the other was a single-arm study in patients with persistent anemia despite stable treatment with a C5 monoclonal antibody. These two studies included a broad population of patients with PNH and both yielded positive results, demonstrating robust efficacy and a favorable safety profile. Once-daily oral monotherapy with Ciprocopan Succinate Tablets may provide sustained and comprehensive disease control for patients with PNH, together with a favorable safety profile and the potential for long-term treatment, underscoring its innovative value and global competitiveness in PNH care. [References] Red Blood Cell Diseases (Anemia) Group, Chinese Society of Hematology, Chinese Medical Association. Chinese Guideline for the Diagnosis and Treatment of Paroxysmal Nocturnal Hemoglobinuria (2024 Edition). Chinese Journal of Hematology, 2024, 45(8): 727-737. Hillmen P, Lewis SM, Bessler M, et al. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med, 1995, 333(19): 1253-1258. Dingli D. Improved therapy for paroxysmal nocturnal hemoglobinuria. Ann Blood. 2026;11:8. doi:10.21037/aob-2025-1-62 Xu G, et al. Efficacy and safety of switching to oral HSK39297 monotherapy in paroxysmal nocturnal hemoglobinuria patients with persistent anemia despite anti-C5 therapy: a phase 3 study (HSK39297-302). Presented at EHA 2026; Abstract PS1786. Phase III Clinical Study Report of HSK39297 Tablets Prescribing Information for Ciprocopan Succinate Tablets; Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296-1310. Risitano AM, et al. Br J Haematol. 2022;196:288-303. Hillmen P, et al. N Engl J Med. 2006;355:1233-1243. Peffault de Latour R, et al. Blood. 2015;125(5):775-783.4. Panse J, et al. Value Health. 2023;26(Suppl):S468.. Dingli D, et al. Ann Hematol. 2022;101:251-263. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultLicense out/inDrug Approval

23 Jul 2026

·www.globenewswire.com

Correction: (Title Correction) Nuvectis Announces Marketing Approval of Ciprocopan (NXP100) in China for the Treatment of Patients with PNH Previously Untreated with Complement Inhibitors

First global approval of a once-daily, orally administered, Complement Factor B inhibitorApproval based on robust efficacy and safety data from Haisco's broad completed clinical development program in PNHCiprocopan application for marketing approval in China for the treatment of patients with PNH previously treated with anti-C5 therapies is currently under reviewCiprocopan has the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for patients requiring continuous life-long treatment Fort Lee, NJ, July 23, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today announced that ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor, received marketing approval from the National Medicinal Products Administration of China (NMPA) for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) previously untreated with Complement inhibitors (treatment naive). As the world's first approved once-daily oral Complement Factor B inhibitor, ciprocopan offers patients living with PNH a new, effective, safe and convenient treatment option and provides important clinical and regulatory validation and further supports the therapeutic potential of once-daily oral Factor B inhibition in PNH and other complement mediated diseases. “We are delighted that ciprocopan received its first marketing approval in China for the treatment of patients with PNH previously untreated with Complement inhibitors, and congratulate our partner Haisco on this tremendous achievement,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “With Factor B inhibitors expected to become the leading class in the multi-billion-dollar PNH market over time, ciprocopan, as the currently only once a day oral therapy, is well positioned to obtain meaningful market share, if approved outside of China. Beyond PNH, ciprocopan could become an important treatment option across several other complement-mediated diseases, where the convenience advantage could be important for patient compliance and long-term clinical outcomes.” Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, "This first ciprocopan approval is an important milestone for Chinese patients living with PNH and we are excited to work closely with Nuvectis in order to bring this important new treatment option to patients worldwide." The key basis for approval was a head-to-head Phase 3 study of ciprocopan versus Soliris (eculizumab) in patients with PNH patients previously untreated with Complement inhibitors. The study met all primary and secondary endpoints and demonstrated ciprocopan’s superiority over eculizumab, including reaching a hemoglobin target of 12 g/dL in 59.5% vs 8.3% in patients treated with eculizumab, a hemoglobin increase from baseline of approximately 5.0 g/dL vs 2.2 g/dL, and reduced transfusion requirements with 94.6% of patients vs 69.4% not requiring transfusions during the study. The study also demonstrated a favorable safety profile for ciprocopan vs eculizumab with no adverse events leading to treatment discontinuation or study withdrawal. Unlike terminal complement inhibitors such as the C5 inhibitors Soliris and Ultromiris, Factor B inhibition blocks the amplification of the alternative pathway while preserving the classical and lectin pathways, designed to provide comprehensive control of both intravascular and extravascular hemolysis, leading to better efficacy compared to the C5 inhibitors’, as demonstrated in head to head clinical trials. Haisco independently developed ciprocopan and is responsible for its development, regulatory approvals, and commercialization in China. Under the June 2026 exclusive license agreement with Haisco, Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India and certain Southeast Asia countries. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “might”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “will”, “would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements are based on Nuvectis Pharma, Inc.’s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products ciprocopan (NXP100), and statements regarding the projections of the commercial potential of ciprocopan in PNH and other complement mediated diseases. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled “Risk Factors” in our first quarter 2026 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections. Company Contact: Ron BentsurChairman, Chief Executive Officer and Presidentrbentsur@nuvectis.com Media Relations Contact: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com

Clinical ResultLicense out/inPhase 3Drug Approval

23 Jul 2026

·www.biospace.com

Ciprocopan (NXP100) Receives Marketing Approval in China for the Treatment of Patients with PNH Previously Untreated with Complement Inhibitors

First global approval of a once-daily, orally administered, Complement Factor B inhibitor Approval based on robust efficacy and safety data from Haisco's broad completed clinical development program in PNH Ciprocopan application for marketing approval in China for the treatment of patients with PNH previously treated with anti-C5 therapies is currently under review Ciprocopan has the potential to become an effective therapy in multiple complement-mediated diseases and provide a convenience advantage as a once-daily oral treatment option for patients requiring continuous life-long treatment Fort Lee, NJ, July 23, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today announced that ciprocopan (NXP100), a once-daily oral complement Factor B inhibitor, received marketing approval from the National Medicinal Products Administration of China (NMPA) for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) previously untreated with Complement inhibitors (treatment naive). As the world's first approved once-daily oral Complement Factor B inhibitor, ciprocopan offers patients living with PNH a new, effective, safe and convenient treatment option and provides important clinical and regulatory validation and further supports the therapeutic potential of once-daily oral Factor B inhibition in PNH and other complement mediated diseases. “We are delighted that ciprocopan received its first marketing approval in China for the treatment of patients with PNH previously untreated with Complement inhibitors, and congratulate our partner Haisco on this tremendous achievement,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur continued, “With Factor B inhibitors expected to become the leading class in the multi-billion-dollar PNH market over time, ciprocopan, as the currently only once a day oral therapy, is well positioned to obtain meaningful market share, if approved outside of China. Beyond PNH, ciprocopan could become an important treatment option across several other complement-mediated diseases, where the convenience advantage could be important for patient compliance and long-term clinical outcomes.” Dr. Pangke Yan, Chief Executive Officer of Haisco, commented, "This first ciprocopan approval is an important milestone for Chinese patients living with PNH and we are excited to work closely with Nuvectis in order to bring this important new treatment option to patients worldwide." ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The key basis for approval was a head-to-head Phase 3 study of ciprocopan versus Soliris (eculizumab) in patients with PNH patients previously untreated with Complement inhibitors. The study met all primary and secondary endpoints and demonstrated ciprocopan’s superiority over eculizumab, including reaching a hemoglobin target of 12 g/dL in 59.5% vs 8.3% in patients treated with eculizumab, a hemoglobin increase from baseline of approximately 5.0 g/dL vs 2.2 g/dL, and reduced transfusion requirements with 94.6% of patients vs 69.4% not requiring transfusions during the study. The study also demonstrated a favorable safety pro ciprocopan vs eculizumab with no adverse events leading to treatment discontinuation or study withdrawal. Unlike terminal complement inhibitors such as the C5 inhibitors Soliris and Ultromiris, Factor B inhibition blocks the amplification of the alternative pathway while preserving the classical and lectin pathways, designed to provide comprehensive control of both intravascular and extravascular hemolysis, leading to better efficacy compared to the C5 inhibitors’, as demonstrated in head to head clinical trials. Haisco independently developed ciprocopan and is responsible for its development, regulatory approvals, and commercialization in China. Under the June 2026 exclusive license agreement with Haisco, Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India and certain Southeast Asia countries. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes NXP100, a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP900 and NXP200, in development for the treatment of advanced cancers. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate”, “believe”, “contemplate”, “could”, “estimate”, “expect”, “intend”, “seek”, “may”, “might”, “plan”, “potential”, “predict”, “project”, “target”, “aim”, “should”, “will”, “would”, or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward looking statements are based on Nuvectis Pharma, Inc.’s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for its pipeline products ciprocopan (NXP100), and statements regarding the projections of the commercial potential of ciprocopan in PNH and other complement mediated diseases. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled “Risk Factors” in our first quarter 2026 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Other than statements of historical fact, all statements are considered forward-looking statements and are based on our interpretations of past events as well as current expectations, estimates, and projections. Company Contact: Ron Bentsur Chairman, Chief Executive Officer and President rbentsur@nuvectis.com Media Relations Contact: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com

Clinical ResultLicense out/inDrug ApprovalPhase 3

100 Deals associated with Ciprocopan

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemoglobinuria, Paroxysmal	China	Sichuan Haisco Pharmaceutical Co., Ltd.	21 Jul 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	Phase 3	China	Haisco Pharmaceutical Group Co., Ltd.	07 Apr 2026
Lupus Nephritis	Phase 2	China	Haisco Pharmaceutical Group Co., Ltd.	18 Nov 2025
Hepatic Insufficiency	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	09 Apr 2026
Atypical Hemolytic Uremic Syndrome	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	16 Jul 2025
Cold Agglutinin Disease	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	16 Jul 2025
Purpura, Thrombocytopenic, Idiopathic	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	16 Jul 2025
C3 glomerulopathy	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	25 Dec 2023
Idiopathic Membranous Glomerulonephritis	Phase 1	China	Tibet Haisco Pharmaceutical Co. Ltd.	25 Dec 2023
Age Related Macular Degeneration	IND Approval	China	Haisco Pharmaceutical Group Co., Ltd.	12 Nov 2025
Myasthenia Gravis	IND Approval	China	Haisco Pharmaceutical Group Co., Ltd.	03 Nov 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07052838 (HSK39297-302, EHA2026)	Phase 3	Hemoglobinuria, Paroxysmal	36	HSK39297 200 mg (Paroxysmal Nocturnal Hemoglobinuria + Persistent Anemia Despite Anti-C5 Therapy)	ovchizddxg(qfkxlybhsn) = azfdqqvywc tjflttyswp (llwzofdaxp ) View more	Positive	12 May 2026
NCT06799546 (EHA2026)	Phase 3	Hemoglobinuria, Paroxysmal	73	HSK39297 200mg once daily	sxnhrxjuib(abxafmereu) = kmeyqsimxb idtcamwika (tvfuscwuox, 43.2 - 75.7) View more	Superior	12 May 2026
NCT06799546 (EHA2026)	Phase 3	Hemoglobinuria, Paroxysmal	73	Eculizumab	sxnhrxjuib(abxafmereu) = rjqpmilflr idtcamwika (tvfuscwuox, 2.8 - 19.4) View more	Superior	12 May 2026
NCT06350279 (Pubmed \| Clin Transl Sci) Manual	Phase 1	-	96	HSK39297	siljnsduyt(gqelpcsdkj) = single and multiple doses of HSK39297 were safe and well tolerated in all subjects edyssdndup (czzgxxmojh ) View more	Positive	01 Jul 2025

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