Summary of the Conference Call for 诺诚健华 Company and Industry Overview - The conference call focuses on 诺诚健华 (Nuo Cheng Jian Hua) and its drug 奥布替尼 (Obutinib) for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting over 8 million patients globally, with more than 1 million in China [2][3]. Key Points and Arguments Clinical Trial Results - The IIb clinical trial results for 奥布替尼 show a significant SL4 response rate at week 48 of 57.1% in the 75 mg QD group compared to 34.4% in the placebo group (p<0.05), indicating substantial efficacy in treating SLE [2][5]. - In a subgroup of patients with more severe disease (baseline steroid dose ≥10 mg/day or baseline urine protein ≥1 g/24 hours), the 75 mg QD group demonstrated even greater efficacy, with differences of 30% and 36% compared to the placebo group [5][8]. - 奥布替尼 exhibited good safety and tolerability, with no new safety signals identified, aligning with the BTK inhibition mechanism and SLE disease biology [2][6]. Steroid Reduction - The treatment group showed a significant reduction in glucocorticoid use, with 71.1% of patients successfully reducing their steroid dose to below 7.5 mg/day compared to 43.6% in the placebo group, highlighting the potential to minimize long-term steroid-related side effects [2][6]. Future Clinical Trials - 诺诚健华 plans to initiate a Phase III clinical trial with 484 patients, focusing on the same efficacy endpoints as the IIb trial, expected to start patient enrollment in Q1 2026 [2][7]. - The trial design aligns with international standards, incorporating mandatory steroid reduction protocols to meet the higher requirements set by the CDE for SLE drug trials [4][9]. Market Potential and Commercialization - 奥布替尼 is the first BTK inhibitor to enter Phase III trials for SLE, presenting a significant market opportunity, especially given the limited availability of new small molecule drugs in the past 20 years [3][8]. - The company plans to establish its own commercialization team post-approval and has synergistic effects with other T2 inhibitors to support market promotion [4][10]. Regulatory Landscape - The CDE has tightened clinical requirements for SLE drugs, necessitating lower steroid doses and more rigorous trial designs. 诺诚健华's Phase III study aims to meet these stringent standards to ensure data consistency with global results [9][10]. International Collaboration - 诺诚健华 has partnered with Xenios to advance overseas market opportunities, focusing on SLE and multiple sclerosis (MS) projects, with expectations for the IIb results to inform future international development strategies [12][13]. Additional Important Information - 奥布替尼's mechanism of action shows high selectivity for BTK, with significant inhibition in preclinical models, supporting its development as an effective SLE treatment [3][8]. - The drug's oral formulation offers advantages in convenience and compliance, avoiding issues associated with large molecule biologics [8]. This summary encapsulates the critical insights from the conference call regarding 诺诚健华's developments in SLE treatment with 奥布替尼, highlighting its clinical efficacy, safety profile, market potential, and strategic plans for future trials and commercialization.

Core Viewpoint - The company, Innovent Biologics, announced that its novel BTK inhibitor, Orelabrutinib, has met the primary endpoint in a Phase IIb clinical trial for treating systemic lupus erythematosus (SLE) and has received approval from the National Medical Products Administration (NMPA) to initiate Phase III registration trials [1][2]. Group 1: Clinical Trial Results - In the Phase IIb trial, 187 patients were randomized into three groups: two dosage groups of Orelabrutinib (75 mg and 50 mg once daily) and a placebo group [1]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [1]. - The 75 mg dosage group also demonstrated a dose-dependent improvement in efficacy compared to the 50 mg group [1]. Group 2: Secondary Endpoints and Subgroup Analysis - At week 48, the SRI-6 response rate and the British Isles Lupus Assessment Group Composite Endpoint (BICLA) response rate for the 75 mg group were significantly higher than those of the placebo group (p<0.05) [2]. - In patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg group improved by 35% compared to the placebo [2]. - In a subgroup with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg group increased by 43% compared to the placebo [2]. Group 3: Safety and Market Potential - Orelabrutinib exhibited good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [2]. - Orelabrutinib is the first BTK inhibitor to demonstrate significant efficacy in a Phase II trial for SLE, with previous Phase IIa data presented at the European League Against Rheumatism (EULAR) conference [2]. - The company aims to accelerate clinical development to provide better treatment options for patients with SLE and other autoimmune diseases, addressing a significant unmet clinical need [3].

Core Viewpoint - The company has achieved a significant milestone with its BTK inhibitor, Orelabrutinib, in the treatment of systemic lupus erythematosus (SLE), as the Phase IIb clinical trial met its primary endpoint and received approval from the National Medical Products Administration (NMPA) to initiate Phase III trials [1][2]. Group 1: Clinical Trial Progress - The Phase IIb clinical trial demonstrated that Orelabrutinib showed excellent efficacy, good tolerability, and safety in patients treated for 48 weeks [2]. - A total of 187 patients were enrolled in the study, randomized into three groups: Orelabrutinib 75 mg, 50 mg, and a placebo group [2]. - The primary endpoint was the SLE Response Index-4 (SRI-4) response rate at week 48, where the 75 mg group showed a significant response rate of 57.1% compared to 34.4% in the placebo group (p < 0.05) [2]. - The 75 mg dose also outperformed the 50 mg dose, indicating a dose-dependent improvement in efficacy [2]. Group 2: Efficacy in Subgroups - In patients with baseline disease activity BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg group showed a corrected difference of 35% compared to the placebo [3]. - For patients with baseline disease activity BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K score ≥ 4, the corrected difference in SRI-4 response rate was 43% [3]. - Orelabrutinib demonstrated good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biological characteristics of SLE [3]. Group 3: Background on SLE - SLE is a systemic autoimmune disease that can lead to severe organ and neurological damage, and even death [4]. - The global prevalence of SLE is approximately 8 million, with around 1 million patients in China, the highest number globally [4]. - The most common SLE patients are young and middle-aged women, requiring long-term management and presenting a significant unmet medical need [4].

Core Insights - The new BTK inhibitor, Oubretyn, developed by the biopharmaceutical company Nuo Cheng Jian Hua, has achieved its primary endpoint in the Phase IIb clinical trial for treating systemic lupus erythematosus (SLE) and has received approval from the National Medical Products Administration (NMPA) to initiate Phase III registration clinical trials [2][4]. Group 1: Clinical Trial Results - In the Phase IIb study, 187 patients were randomized into three groups: two dosage groups of Oubretyn (75 mg and 50 mg once daily) and a placebo group [2]. - The primary endpoint, the SLE Response Index-4 (SRI-4) response rate at week 48, showed that the 75 mg Oubretyn group had a significantly higher response rate compared to the placebo group (57.1% vs. 34.4%, p<0.05) [2]. - The 75 mg Oubretyn group also demonstrated superior efficacy over the 50 mg group, indicating a dose-dependent improvement trend [2]. Group 2: Subgroup Analysis - In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B, the SRI-4 response rate for the 75 mg Oubretyn group increased by 35% compared to the placebo group [3]. - For patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg Oubretyn group improved by 43% compared to the placebo group [3]. Group 3: Safety and Market Potential - Oubretyn has shown good tolerability and safety, consistent with the mechanism of action of BTK inhibitors and the biology of SLE [3]. - Oubretyn is the first BTK inhibitor to demonstrate significant efficacy in a Phase II clinical trial for SLE, positioning it as a potential first-in-class oral BTK inhibitor for this condition [4]. - The global prevalence of SLE is approximately 8 million, with China having around 1 million patients, indicating a substantial unmet clinical need for effective treatments [4].

Core Viewpoint - The approval of the III phase clinical trial for Obutinib in treating systemic lupus erythematosus (SLE) marks a significant advancement for the company, supported by strong data from the IIb phase trial demonstrating efficacy and safety [1][2][3] Group 1: Clinical Trial Results - The III phase trial will evaluate a daily dose of 75 mg of Obutinib, building on solid data from the IIb phase trial [1] - In the IIb trial, 187 SLE patients were randomized into three groups, with the 75 mg dose showing a significant SLE response index-4 (SRI-4) response rate of 57.1% compared to 34.4% in the placebo group at 48 weeks (p < 0.05) [1] - The 75 mg dose also demonstrated a dose-dependent efficacy trend, with significant improvements in SRI-6 and British Isles Lupus Assessment Group (BILAG) response rates compared to the placebo group (p < 0.05) [1] Group 2: Subgroup Analysis - In patients with baseline BILAG ≥ 1A or ≥ 2B, the SRI-4 response rate for the 75 mg dose improved by 35% compared to the placebo group [2] - Among patients with baseline BILAG ≥ 1A or ≥ 2B and clinical SLEDAI-2K scores ≥ 4, the SRI-4 response rate increased by 43% for the 75 mg dose compared to the placebo [2] Group 3: Future Development Plans - The company aims to accelerate the clinical development of Obutinib, which is a selective, irreversible oral BTK inhibitor with potential best-in-class advantages [3] - The III phase trial is expected to enroll the first patient in Q1 2026, with ongoing trials for immune thrombocytopenic purpura (ITP) and multiple sclerosis (MS) also in progress [3] - Obutinib has already gained significant clinical recognition and market penetration in the hematological malignancies sector, having been included in China's National Reimbursement Drug List (NRDL) [4]

InnoCare Pharma Limited 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 自願公告 奧布替尼治療系統性紅斑狼瘡的IIb期 臨床試驗取得積極結果並啟動III期臨床試驗 本公告乃由諾誠健華醫藥有限公司（「本公司」）自願作出，以告知本公司股東 及潛在投資者有關本公司的最新業務進展。 董事會（「董事會」）欣然宣佈，藥品審評中心(CDE)批准啟動奧布替尼治療系統 性紅斑狼瘡(SLE)的III期臨床試驗。在IIb期臨床試驗堅實數據的強力支持下，III 期研究將評估每日一次75毫克給藥的方案。 IIb期臨床結果展示，在接受治療48週的SLE患者中，奧布替尼展現了卓越的有 效性和良好的耐受性和安全性。本次研究共入組187例患者，按1:1:1隨機分成 三組，即奧布替尼每日一次75毫克和奧布替尼每日一次50毫克兩個劑量組，以 及一個安慰劑組 ...

Core Viewpoint - The biopharmaceutical company, Nuo Cheng Jian Hua, announced the presentation of over 20 research data on its novel BTK inhibitor, Oubatinib, at the 67th American Society of Hematology (ASH) annual meeting, showcasing its efficacy and safety across various lymphoma studies. Group 1: Efficacy and Safety Data - Oubatinib demonstrated a total response rate (ORR) of 89.5% and a complete response rate (CRR) of 78.9% after six treatment cycles, with a median time to response of 2.6 months and a 2-year duration of response (DoR) of 72.4% [2] - In a study involving newly diagnosed primary central nervous system lymphoma (PCNSL), Oubatinib combined with rituximab and high-dose methotrexate showed superior predictive and prognostic value compared to PET-CT, with early clearance of ctDNA and MYD88 [1] - The combination of Oubatinib and Obinutuzumab for initial treatment of marginal zone lymphoma (MZL) showed an ORR of 96.0% and a CRR of 72.0% in 27 evaluable patients, with 100% ORR in 10 patients completing six cycles [3] - Oubatinib combined with rituximab in treatment-naïve MZL patients showed an ORR of 81.8% and a CRR of 72.7%, indicating promising efficacy despite small sample size [4] - Oubatinib combined with bendamustine-rituximab demonstrated favorable tumor response and survival outcomes compared to bendamustine-rituximab alone in high-risk mantle cell lymphoma (MCL) patients [5] Group 2: Real-World Studies and Future Research - A large-scale real-world study provided insights into treatment patterns and outcomes for different genetic subtypes of diffuse large B-cell lymphoma (DLBCL) in China, showing enhanced efficacy of R-CHOP plus BTK inhibitors in MCD-like subtype patients [6] - In the MCD-like treatment group, the CRR for R-CHOP combined with Oubatinib was 81.4% [7] - A prospective study indicated that the combination of pomalidomide, rituximab, and Oubatinib is a potential treatment option for elderly or frail DLBCL patients, achieving a 100% ORR in patients completing three cycles [7] - Oubatinib monotherapy for chronic lymphocytic leukemia (CLL) patients showed a 100% ORR and disease control rate (DCR) in both first-line and subsequent treatments [8] - Additional studies on Oubatinib are set to be presented at the 2025 ASH annual meeting, covering various combinations and treatment strategies for different lymphoma types [8]

Core Viewpoint - 诺诚健华 reported a revenue of 383.94 million yuan for Q3 2025, marking a year-on-year increase of 38.09%, but incurred a net loss of 34.32 million yuan [1][4] Financial Performance - Revenue for Q3 2025 was 383.89 million yuan, up 38.09% year-on-year, while total revenue for the first nine months reached 1.11 billion yuan, a 59.85% increase [3][4] - The company reported a net loss of 34.32 million yuan for Q3 2025, with a net loss of 72 million yuan for the first nine months, a 74.78% reduction compared to the previous year [4][6] - Gross margin improved to 88.8%, up from 86.0% year-on-year [3] Product Performance - The growth in revenue is primarily attributed to the sales of the core product, Acalabrutinib, which generated 1.01 billion yuan in sales for the first nine months, a 45.77% increase [4][7] - Acalabrutinib has been approved for four hematological indications in China and is the first BTK inhibitor approved for relapsed/refractory marginal zone lymphoma [4][5] Market Dynamics - Acalabrutinib's sales are expected to continue growing, with projected revenues of 2.41 billion yuan in 2021, 5.66 billion yuan in 2022, 6.71 billion yuan in 2023, and 10 billion yuan in 2024 [7] - The domestic BTK inhibitor market is becoming increasingly competitive, with five approved products, including Acalabrutinib and others from major pharmaceutical companies [8] - The patent for Ibrutinib, a competing product, will expire in December 2026, potentially leading to an influx of generic versions and intensifying market competition [8] Research and Development - R&D expenses totaled 226.35 million yuan in Q3 2025, accounting for 58.96% of revenue, a decrease from the previous year [3][4] - The company is expanding Acalabrutinib's indications, with ongoing clinical trials for multiple sclerosis and immune thrombocytopenic purpura [7][8]

Core Insights - The company reported a 59.8% year-on-year increase in total revenue for the first three quarters of 2025, reaching 1.12 billion RMB, driven by the continued growth in sales of its core product, BTK inhibitor Oubatinib (Yinokai®), and an upfront payment from a licensing agreement with Prolium [1] Revenue Performance - Oubatinib's revenue for the first three quarters increased by 45.8% year-on-year, amounting to 1.01 billion RMB, surpassing the total revenue of the previous year, attributed to the expanding market for its exclusive indication of marginal zone lymphoma (MZL) and the approval of new indications for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) [1] Loss Reduction - The company's losses significantly narrowed by 74.8%, reducing to 0.07 billion RMB, primarily due to rapid revenue growth and improved cost efficiency [1]

Core Viewpoint - LUPENG Pharmaceutical Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor [1] Company Overview - LUPENG Pharmaceutical is a leading global biopharmaceutical company with a proprietary BeyondX oral drug chemistry platform, focusing on the design, discovery, clinical development, and commercialization of high bioavailability oral drugs to meet unmet medical needs in cancer and autoimmune disease patients [5] Key Product Information - The company's core product, LP-168, is a dual BTK inhibitor in the NDA stage, recognized as the world's first and only "covalent and non-covalent" dual BTK inhibitor, showing best-in-class potential in oncology and autoimmune disease fields [5] - LP-168 can eliminate both wild-type and resistant mutant BTK tumor cells, overcoming resistance limitations seen in traditional BTK inhibitors [5] - The product has demonstrated significant clinical benefits and excellent safety, with a lower incidence of treatment-related adverse events compared to previous BTK inhibitors [5] Market Potential - LP-168 has strategically extended its application to autoimmune indications, targeting major autoimmune diseases such as ITP, pMN, MS, and gMG, capturing significant value in the rapidly growing autoimmune treatment market [6] - The global BTK inhibitor market is projected to grow from $12 billion in 2024 to $25.1 billion by 2035, with a compound annual growth rate (CAGR) of 6.8% from 2025 to 2035 [6] Financial Performance - The company reported losses of RMB 159.4 million and RMB 3.4 million for the years 2023 and 2024, respectively [7] - For the six months ending June 30, 2024, and June 30, 2025, the company recorded profits of RMB 32.9 million and RMB 35.9 million, respectively [7]