A：The new drug candidate, SOC 1310, has entered the pivotal stage less than two years from its phase 1 trial, indicating an extraordinary pace in the industry. The company is on the path for its first global approval by early 2027. Another program, L 30 or 31, is in development as a best-in-class topical therapy. Furthermore, the company has built a global organization that is rapidly expanding its portfolio with highly differentiated programs and is expected to initiate a phase II study next year following ongoing combination studies.

A：The commercial business in China is currently profitable and on a steady, profitable growth path. However, the pace has been slower than expected. Despite a complex and dynamic environment, there are encouraging signs of progress, such as faster regulatory reviews and more transparent R&D negotiations. The company has one of the strongest commercial teams and a portfolio of differentiated high-potential assets, which contributes to their confidence in the long-term potential of the business.

A：In the phase 1 study for previously treated extensive stage small cell lung cancer, at the 1.6 mg per kilogram dose, an overall response rate of 68% and a disease control rate of 94% were observed. Notably, there were strong efficacy signals in patients with brain metastases, with an overall response rate of 44% in brain metastases lesions. The median duration of response was 6.1 months and the median progression-free survival was 5.4 months. The safety profile at the 1.6 mg per kilogram dose was favorable, with only 13% of patients experiencing grade 3 or higher treatment-related adverse events.

A：The company has initiated enrollment in a registration phase 3 trial for extensive stage small cell lung cancer with the potential for an accelerated approval submission. They are also advancing the first line strategy with plans to start a phase II study next year following results from ongoing combination studies evaluating the new drug candidate with PDL-1, with and without chemotherapy. Furthermore, the new drug candidate is being evaluated in neuroendocrine carcinomas, which have a poor prognosis and no targeted therapies, with plans to present results in the first half of the following year and move into a registrational study thereafter.

A：The internally discovered asset Cl 1 oh 3 is in phase 1 for atopic dermatitis and has a dual mechanism targeting both T and B cell inflammation with an extended half-life for less frequent dosing. A subcutaneous formulation is being developed, and preclinical results suggest its potential for use in other inflammatory diseases with human data expected in 2026. Another internally discovered asset, Cl 6201, is an lrrc 15 targeted antibody that remains on track for a U.S. IND submission by year-end and a global phase 1 study initiation early next year. Additionally, TL 1 222, another internally discovered asset, is in development as a next-generation PD-1 IL-12 immunocytokine designed to deliver cytokine signaling directly into the tumor microenvironment.

A：The updates include a contingent map expansion across multiple autoimmune indications, a positive global phase C study in seronegative TNG, and the initiation of phase 3 studies for ocular Ng myositis and thyroid IDC in China. A global pivotal phase 2/3 CD in primary membranous nephropathy was also initiated in October with plans to enroll patients in China this quarter. These achievements reflect the pipeline's depth and quality.

A：The China business has experienced significant developments such as the addition of phase 3 studies for seronegative GMG, and the potential inclusion of China in the interim analysis plan for the global Rainier phase, which could support an accelerated approval submission next year. The business is focused on reshaping the management of chronic diseases through new treatments like Viv Gard, which is commercially profitable, and the introduction of new indications and formulations such as Sero-negative GMG and Car Xt.

A：Zhi is expecting a 'catalyst-rich year' with updates on premium data for first-line small cell lung cancer, results from the incarcerated study, and data from registration studies in first-line lung cancer and neuroendocrine carcinomas. New trials with novel combinations across spinal therapy are also planned, alongside the initiation of global phase 1 development for Zl 1103 or Il 1005, and advancing L 6201 or LRC 15 into global phase 1 development.

A：Total revenue grew 14% year over year to $116.1 million, driven by higher sales of Nusra and increasing market coverage. For the coming year, the company has updated its four-year total revenue guidance to at least $460 million. The cost structure showed significant improvements with RD expenses decreasing 27% and HNA expenses increasing only 4%. Loss from operations improved 28%, and adjusted loss from operations excluding certain non-hatch items was $28 million, a 42% improvement. Despite expecting a meaningful quarter-over-quarter improvement in adjusted operating loss, profitability is now expected to shift beyond the fourth quarter due to a lower revenue base this year. The company remains financially strong, with a China business that is commercially profitable and growing, and maintains a solid financial foundation with $817 million in cash.

A：Car Xt is currently under regulatory review and has the potential to redefine schizophrenia treatment in China by introducing the first new mechanism of action in over 70 years. It has been included in the China Schizophrenia Prevention and Treatment Guidelines, underscoring its strong differentiation and anticipated clinical impact. A successful review would significantly bolster the company's growth prospects.

A：The key drivers for growth include V Gar T, new patient additions, and continued growth in durability of treatment. As for profitability, it will be driven by the growth of the business in China, which is currently profitable and can cover RD and corporate costs.

A：The initial data readout for Zl 15 oh 3 is expected in 2026. The molecule is anticipated to have a fast and sustained effect due to its dual IO and TROP-2 inhibition, and it is in a phase of initiating trials with multiple countries involved.

A：Zl 15 oh 3 has the potential to address a large market as it is a common disease, and even a small percentage of capture in AD could represent a substantial opportunity. Additionally, it has the possibility of expanding to other Th2 diseases, which makes it a very promising product.

A：The near-term focus for 1310 is to get the registration trial up and running and to expand into first-line therapy and neuroendocrine tumors. This reflects a strategy to advance the pipeline and continue to build on the company's profitable commercial business in China.

A：The company has two INDs (Investigational New Drugs) in the process, one of which will start enrolling this year, and another set to start in January. PD 1-IL 12 is a candidate that may have an IND next year, with the possibility of enrolling the first patient in the second half.

A：The company plans to launch Car T-cell therapies in China with a targeted sales force, taking advantage of the concentrated patient approach in larger institutions. The opportunity is significant with millions of patients suffering from schizophrenia, and the company looks forward to getting approval and launching in 2026, moving toward a New Drug Registration listing in 2027.

A：While a detailed update on the $2 billion target by 2028 was not provided, the company feels good about its current portfolio and anticipates significant sales from the US in small cell lung cancers as early as late 2027. The expansion to new endocrine tumors next year will be discussed in terms of the pathway to approval and the bar to clear for such expansion.

A：The potential of the new therapy for patients with highly proliferative tumors with a poor prognosis, such as G3 adenocarcinoma (GPS) and other types, is significant. The proposed study design involves a single arm trial to characterize the response rate, with discussions planned with regulatory authorities for potential accelerated approval based on preliminary results.

A：The company's guidance has diverged from previous expectations, particularly in China. Regarding the fourth quarter cash breakeven target, it was mentioned that the target remains intact.

A：The company's strategy and focus regarding its portfolio and early-stage pipeline build-up involve expanding into oncologyADCs (Antibody-Drug Conjugates) and continuing the development of therapies in immunology, including PD 1-IL 12. The company aims to provide more color on the decision-making process for selecting which therapies to pursue and which to leave out.

A：Viv Gard's performance is currently slower than initial expectations, with a focus on getting patients to at least three cycles of treatment. Despite this, there is underlying growth due to good response to national guidelines and promotional efforts. The market opportunity is seen as a long-term build.

A：Viv Gard is expected to gain share as Lepor goes generic. The market opportunity is related to gaining share from Lepor as it becomes generic, which is anticipated to start kicking in from the fourth quarter onwards and set the stage for further gains in the following year.

A：Zack Doro has faced supply constraints that were not anticipated at the beginning of the year. The company is working through these constraints, and it is hoped that by 2026, supply issues will be resolved to fully meet market demand.

A：Profitability is expected to continue on a positive path, with continued good progress in cash earnings. Top-line growth is anticipated to drive this profitability, and while the company might not reach certain targets in the fourth quarter, there will still be significant improvement, setting the stage for 2026.

A：The company's portfolio is expected to grow through a blend of internal and external opportunities. Many products in development come from their protein science laboratories. The company will continue to focus on antibody drug conjugates, innovating with other antibodies, and exploring immunocytes and T cell engagers outside of oncology.

A：The company's global pipeline is focusing on oncology and autoimmune and anti-inflammatory diseases, both for internal global development and for regional opportunities.

A：The company is seeing good underlying growth with Viv Gard in terms of the number of cycles patients receive. The average patient cycle duration is expected to continue to rise towards the goal of three cycles per year, supported by national guidelines and promotional efforts. For Q4 and 2026, it is expected that the sequential quarterly growth in the number of vials sold will continue in the low teens.

A：Bima is experiencing an attenuated treatment effect according to the EMA data analysis. The company is working with Amgen to review translational markers and subgroups. It is considered challenging to get approval in China with the current data set, so the company is looking at redeploying resources to advance their existing pipeline.