Financial Data and Key Metrics Changes - Net product revenues for the second quarter were $18.1 million, and for the first half, they were $35.5 million, both slightly higher compared to the same periods in the prior year [4][28] - The company reported a net loss of $56.6 million for the second quarter, compared to a net loss of $36.5 million in the same period of 2024, primarily due to one-time restructuring and impairment costs [29] - Total operating expenses for the quarter were $47.8 million on a non-GAAP basis, representing an 8% increase over the prior year, driven by higher R&D costs [28][29] Business Line Data and Key Metrics Changes - The company is focusing on the commercialization of ZENLANTA, which has shown promising data in clinical trials, particularly in combination with glufetamab [5][10] - The LOTUS-seven trial data presented at conferences indicated a complete response rate of 86.7% across 30 efficacy evaluable LBCL patients [5][27] - The company plans to expand enrollment to 100 patients at the selected dose to support regulatory discussions [6][9] Market Data and Key Metrics Changes - The company estimates that ZENLANTA could reach peak sales of $600 million to $1 billion in the U.S. market, with significant opportunities in both DLBCL and indolent lymphomas [11][12] - The DLBCL treatment landscape is divided into complex therapies and broadly accessible therapies, with the latter expected to grow as ZENLANTA is positioned as a preferred option [12][13] Company Strategy and Development Direction - The company is strategically focusing resources on ZENLANTA commercialization and has discontinued early development efforts for other preclinical programs in solid tumors [8][9] - The company aims to position itself for long-term growth by reducing operating expenses and extending its cash runway into 2028 through a recent private placement [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unmet medical need in the second line plus DLBCL landscape and the potential of LOTUS trials to address this need [38] - The company anticipates multiple data catalysts in the remainder of 2025 and 2026, with potential regulatory submissions and approvals expected [31][32] Other Important Information - The company incurred $13.1 million in restructuring and impairment costs related to the closure of its UK facility [29] - The company plans to engage with regulatory authorities regarding the LOTUS trials and explore potential pathways for approval [56][58] Q&A Session Summary Question: Impact of Roche's complete response letter on DLBCL market - Management noted that while details of the CRL are unknown, they remain confident in the unmet medical need in the second line plus DLBCL landscape and the positioning of LOTUS trials to address this need [38][39] Question: Status of LOTUS V overall survival analysis - Management indicated that it is difficult to speculate on the maturity of overall survival data by year-end, but they will provide updates once the pre-specified number of PFS events is reached [42][44] Question: Durability of responses in LOTUS trials - Management highlighted the unprecedented complete response rates observed in LOTUS trials and expressed confidence in the durability of these responses, with plans to share more data as it matures [48][50] Question: Communication of LOTUS-seven data - Management stated that they are considering the best way to communicate LOTUS-seven data, whether through a company update or at a medical congress, depending on data maturity [59][60] Question: Indolent lymphomas and NCCN inclusion - Management expressed confidence in the ongoing Phase II IIT for MZL and noted that a CR rate of 40% or above would be significant for NCCN inclusion [64][65]

Financial Data and Key Metrics Changes - For Q2 2025, the company reported a net loss of $12.3 million, slightly improved from a net loss of $12.4 million in Q2 2024 [13] - Research and Development (R&D) expenses decreased to $9.4 million from $10 million in the same quarter of 2024, primarily due to reduced costs in several trials [13] - General and Administrative (G&A) expenses increased to $4.3 million from $3.3 million in Q2 2024, mainly due to higher professional fees and personnel costs [14] - As of June 30, 2025, cash and investments totaled approximately $204 million, providing a cash runway into 2029 [15] Business Line Data and Key Metrics Changes - The CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) showed a statistically significant reduction in cough frequency across all dose groups [5] - The quality of life assessment using the Lester Cough Questionnaire (LCQ) indicated significant improvements, with increases of 3.7 and 3.4 points for the 54 mg and 108 mg BID doses, respectively [6] Market Data and Key Metrics Changes - The company estimates approximately 228,000 patients with non-IPF interstitial lung diseases, with 50% to 60% experiencing uncontrolled cough, effectively doubling the market opportunity for cough treatment [10] Company Strategy and Development Direction - The company plans to initiate Phase III trials for Haduvio in the first half of next year, focusing on chronic cough in both IPF and non-IPF patients [9][11] - There is an emphasis on patient-centric development and commercialization strategies, as indicated by feedback from patient advisory boards [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to execute its strategy and create value following positive data from recent trials [5] - The end of Phase II meeting with the FDA is anticipated in Q4 2025, where alignment on the Phase III program will be discussed [9][30] Other Important Information - The company is preparing for a study in refractory chronic cough, with plans to initiate a Phase IIb parallel arm study in the first half of next year [11] - The company has received positive feedback from pulmonologists regarding the potential for Haduvio in treating non-IPF interstitial lung diseases [34] Q&A Session Summary Question: Progress on the respiratory depression study - Management confirmed that the respiratory safety study is ongoing with two active sites and expects to have data for the end of Phase II meeting [20][22] Question: Key questions for the upcoming FDA meeting - The focus will be on data from the CORAL trial, adequacy of the program, and specifics of the Phase III protocol [30][31] Question: Parallel design for the non-IPF ILD study - Management indicated that the study will have minimum criteria for enrollment, allowing for a broader patient base while focusing on fibrosis and cough [46][50] Question: Tolerability and adverse events from the CORAL trial - Management expressed satisfaction with the CORAL data and indicated no changes are anticipated going forward [52] Question: Dose selection for the Phase III study - The 54 mg BID dose is expected to be a key dose moving forward based on its performance in the CORAL trial [57] Question: Additional data from the CORAL trial - Management confirmed that the LCQ data complements objective cough data and will be discussed in future meetings [63][64] Question: Commercialization plans and partnering - The company is focused on its Phase III program in the U.S. and may consider partnerships in Europe or Japan [104]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for clinical trials of its self-developed B019 injection, aimed at treating refractory systemic lupus erythematosus [2]. Company Summary - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [2]. - The drug has previously been approved for clinical trials for two other indications: relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma, with approvals granted in October 2023 and December 2024, respectively [2].

Core Insights - The company, 开拓药业-B (09939), has announced positive top-line data from the Phase II clinical trial of its self-developed KX-826 solution for treating hair loss, achieving primary endpoints with statistical significance and clinical relevance [1][2] Efficacy - The Phase II trial, which included 90 patients, demonstrated significant efficacy for both the 0.5% BID and 1.0% BID groups compared to the placebo group, with the 0.5% BID group showing an increase of 22.39 hairs/cm and the 1.0% BID group showing an increase of 21.87 hairs/cm, while the placebo group showed an increase of only 8.73 hairs/cm [1] - The 0.5% BID group had a statistically significant increase of 13.66 hairs/cm over the placebo (P=0.002), and the 1.0% BID group had an increase of 13.14 hairs/cm over the placebo (P=0.004) [1][2] - Hair Growth Assessment (HGA) metrics also showed significant improvement for both treatment groups compared to the placebo, with the 0.5% BID group showing statistical significance (P=0.000) and the 1.0% BID group also showing significance (P=0.013) [2] Safety - KX-826 demonstrated satisfactory safety and tolerability in the clinical trial, with a low incidence of adverse events and no reports of drug-related sexual dysfunction or new safety signals [2] - The Independent Data Monitoring Committee (IDMC) reviewed the results and recommended that the Phase III clinical trial continue based on the current safety and efficacy data, maintaining the same groups and sample sizes [2]

Core Viewpoint - The phase III clinical trial of LZM012, a recombinant human IL-17A/F humanized monoclonal antibody injection developed by Zhuhai Lizhu Biotech Co., Ltd. and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd., has achieved its primary endpoint in patients with moderate to severe plaque psoriasis [1] Group 1: Clinical Trial Results - The trial was a multicenter, randomized, double-blind, positive-controlled study comparing LZM012 to the control group, Secukinumab [1] - At week 12, the PASI 100 response rate for LZM012 was 49.5%, compared to 40.2% for Secukinumab, indicating non-inferiority and superiority of LZM012 [1] - The PASI 75 response rate at week 4 was 65.7% for LZM012 versus 50.3% for Secukinumab, demonstrating a faster onset of action for LZM012 [1] - At week 52, the PASI 100 response rates for LZM012 in the 320mg Q4W and 320mg Q8W maintenance treatment groups were 75.9% and 62.6%, respectively, showing sustained benefits for psoriasis patients [1] Group 2: Safety and Regulatory Progress - The overall safety profile of LZM012 was good, with the incidence of common adverse events comparable to that of the control group [1] - Lizhu Group has submitted a communication application to the National Medical Products Administration (NMPA) for the marketing authorization of LZM012 for the treatment of adult patients with moderate to severe plaque psoriasis, advancing the drug's approval process [1]

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trial notifications for four drugs, indicating progress in its drug development pipeline [1] Drug Development Summary - SHR-8068 Injection: A fully human anti-CTLA-4 monoclonal antibody with a development investment of approximately 214 million yuan [1] - Abediterol Injection: A self-developed humanized anti-PD-L1 monoclonal antibody with a development investment of approximately 887 million yuan [1] - Bevacizumab Injection: A humanized anti-VEGF monoclonal antibody with a development investment of approximately 345 million yuan [1] - Apatinib Mesylate Tablets: An innovative small molecule targeted drug with a development investment of approximately 587 million yuan [1] Regulatory Process Summary - Following the approval of the clinical trial notifications, the drugs must undergo clinical trials and receive further review and approval from the National Medical Products Administration before they can be manufactured and marketed [1]

Core Viewpoint - Micron Biologics announced that the final results of the key Phase III clinical trial (DEB study) for its self-developed drug, Sidabone, targeting first-line treatment of diffuse large B-cell lymphoma (DLBCL), have shown that the event-free survival (EFS) of the trial group is significantly better than that of the control group, achieving the primary endpoint of the study [1] Group 1 - Sidabone combined with R-CHOP is the first treatment regimen in the world to demonstrate a significantly higher complete response (CR) rate than R-CHOP in a Phase III clinical trial for first-line DLBCL treatment [1] - The top-line analysis indicates that the EFS in the trial group shows statistically significant differences compared to the control group, further validating that the Sidabone combination regimen can provide significant and sustainable efficacy for newly treated MYC and BCL2 double-expressing DLBCL patients, with good safety [1] - The company is preparing to submit for routine approval for this indication [1] Group 2 - A comprehensive analysis of the final results of the study will be presented at upcoming academic conferences or journals [1]

Summary of Jasper Therapeutics (JSPR) Update / Briefing July 07, 2025 Company Overview - **Company**: Jasper Therapeutics (JSPR) - **Focus**: Development of therapies for chronic spontaneous urticaria (CSU) using the drug vaprolimab Key Points Industry and Company Context - The conference call was focused on updated data from the BEACON trial and initial data from the open label extension study evaluating vaprolimab in patients with CSU [4][20] Core Findings from the BEACON Trial - **Efficacy**: - A greater than 25 drop in UAS7 (Urticaria Activity Score over 7 days) was observed in the 240 mg and 360 mg single dose cohorts, with 78% complete response and 89% well-controlled disease by week four [4][21] - In the open label extension study, 73% of patients achieved complete response and 82% well-controlled disease at the 12-week assessment with a mean reduction in UAS7 scores of greater than 25 points [17][22] - **Safety Profile**: - Vaprolimab demonstrated a favorable safety profile with no dose-limiting toxicities reported. Treatment emergent adverse events were similar in both active and placebo groups [13][22] - Mild transient adverse events were observed, including taste changes and neutrophil count reductions, but these were self-resolving and did not lead to discontinuations [14][15] Issues Identified - **Confounding Results**: - Two cohorts (240 mg Q8 weeks and 240 mg followed by 180 mg Q8 weeks) showed confounded results due to an issue with a specific drug product lot (lot A34954), which resulted in lower than expected drops in mean tryptase levels and no discernible effect on UAS7 in 10 out of 10 patients dosed with this lot [5][12] - An investigation into the affected lot is ongoing, with results expected in the coming weeks [6][20] - **Next Steps**: - Additional 10 to 12 patients will be enrolled in the affected cohorts to ensure a robust data set for the Phase IIb CSU study expected to commence mid-2026 [6][20] Financial and Operational Insights - **Cash Runway**: - Current guidance into the fourth quarter remains unchanged, but the company is evaluating its cost structure and may need to raise additional capital to extend its runway [54] - **Regulatory Communication**: - The company is in communication with the FDA regarding the lot issue, but there are no safety concerns associated with the affected lot [48][41] Additional Observations - **Durability of Responses**: - The data suggests that the depth of triptase reduction correlates with the depth of UAS7 reductions, indicating a potential for durable effects with the 180 mg dosing regimen [55] - **Patient Management**: - Patients who received the inactive dose from the compromised lot will be transitioned to a new drug product that has demonstrated efficacy in other cohorts [20][48] Conclusion - Jasper Therapeutics is optimistic about the potential of vaprolimab as a differentiated therapeutic option for CSU, despite the setback from the compromised drug lot. The company is taking proactive steps to address the issue and continue its clinical development program.

Core Viewpoint - The company ST HuLuWa (605199) has received approval from the National Medical Products Administration for clinical trials of its new product, a modified version of the existing "Pediatric Lung Heat Cough and Asthma Granules," now targeting adult influenza patients [1] Group 1: Product Development - The new product is an improvement on the already marketed "Pediatric Lung Heat Cough and Asthma Granules" [1] - The modified formulation expands its indications to include "heat toxin attacking the lung syndrome" associated with influenza in adults [1] - The product is designed to clear heat and detoxify, relieve cough, and reduce phlegm and wheezing, applicable for conditions like cold, bronchitis, wheezing bronchitis, and bronchopneumonia [1]

Group 1 - The core objective of the study is to evaluate the clinical effectiveness of self-administered selatogrel in preventing all-cause mortality and treating acute myocardial infarction (AMI) in subjects with a recent history of AMI [1] - The study is a multicenter, randomized, double-blind, placebo-controlled trial, marking the first registered global clinical trial initiated by the cardiology department of Dongying People's Hospital [1] - The kickoff meeting included detailed discussions on the research background, study design, inclusion and exclusion criteria, efficacy and safety indicators, and drug administration protocols [1] Group 2 - The successful convening of the kickoff meeting highlights the clinical research capabilities of Dongying People's Hospital in the field of cardiovascular diseases [2] - The hospital's drug clinical trial institution aims to maintain a scientific and rigorous approach, deepen domestic and international research cooperation, and promote the standardization of clinical research [2] - This initiative is expected to enhance the hospital's overall strength and influence in the cardiovascular discipline [2]