Group 1 - The company, 同源康医药-B, announced that its investigational drug,甲磺酸艾多替尼片 (TY-9591), is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with specific EGFR mutations [3] - The board of directors noted unusual fluctuations in the company's stock price and trading volume but confirmed that, apart from the disclosed information, they are not aware of any reasons for these fluctuations or any material information that needs to be disclosed to avoid misleading the market [3] - As of the date of the announcement, the board confirmed that the company's business operations are stable and progressing smoothly, with no significant matters requiring disclosure that would raise concerns for the board or management [3]

Core Viewpoint - The company, ZhiYuanKang Pharmaceutical-B (02410), announced that its investigational drug, TY-9591 (Axitinib), is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1] Group 1 - The proposed indication for TY-9591 is for adult patients with NSCLC who have either exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, along with central nervous system (CNS) metastases [1] - The company's board has noted unusual fluctuations in the stock price and trading volume, but confirmed that they are not aware of any reasons for these fluctuations beyond what has been disclosed [1] - As of the date of the announcement, the board confirmed that the company's business operations are stable and progressing smoothly, with no significant matters requiring disclosure [1]

Core Viewpoint - The company Tongyuan Kang Pharmaceutical-B (02410.HK) announced that its investigational first-class new drug, Tyrosine Kinase Inhibitor (TY-9591), has been proposed for inclusion in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1 - The proposed indication for TY-9591 is for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, along with central nervous system (CNS) metastases [1]

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意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 董事會亦已注意到本公司股份價格及成交量近期出現不尋常波動。經作出合理查 詢後，董事會確認，除上文所披露者外，截至本公告日期，其並不知悉導致有關 波動的任何原因，或為避免本公司證券出現虛假市場而須予披露的任何資料，或 根據香港法例第571章證券及期貨條例第XIVA部須予披露的任何內幕消息。 截至本公告日期，董事會確認本集團的業務經營正常穩定，其核心業務進展順 利，並無任何引起董事會和本公司管理層關注的須予披露的重大事項。 1 上市規則第18A.05條規定的警示聲明：無法保證本公司將能最終成功開發及銷售 相關產品。本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願公告 甲磺酸艾多替尼片（TY-9591片）擬納入優先審評；及 股價及成交量的不尋常變動 浙江同源康醫藥股份 ...

Core Insights - The company is currently awaiting an important decision regarding the filing for Auvelity and its application for AD agitation, which is a significant topic for stakeholders [1] - The company confirmed that a supplemental New Drug Application (sNDA) was submitted, and they are now waiting to provide further updates on this matter [1] - The expectation is that if the sNDA is accepted, it will undergo a standard review due to the current resource constraints and bandwidth considerations at the FDA, which are independent of the submitted package [2]

Summary of Savara (NasdaqGS:SVRA) FY Conference Call - December 02, 2025 Company Overview - **Company**: Savara - **Product**: Molgramostim (MOLBREEVI) - **Market**: Autoimmune Pulmonary Alveolar Proteinosis (APAP) Key Points BLA Resubmission and Regulatory Timeline - The BLA resubmission for Molgramostim is on track for December 2025, with a 60-day review anticipated, leading to a PDUFA date around August 2026 [4][5] - Submissions for MAAs in Europe and the U.K. are expected by the end of Q1 2026 [4][32] Market Opportunity and Patient Population - Approximately 5,500 diagnosed APAP patients identified in the U.S. through claims database analysis [8][9] - The company has confirmed 1,000 patients that are actively managed and have "line of sight" for the U.S. launch [8][9] - Patient concentration is noted in major centers of excellence and large group practices, facilitating a robust launch trajectory [10] Commercial Strategy and Team Preparation - A commercial team of about 30 customer-facing individuals is being established, with hiring planned to be completed post-approval [14][16] - The team is focused on building relationships with healthcare professionals and preparing for patient education and prescription processes upon approval [11][12] Distribution and Payer Mix - A single exclusive specialty pharmacy will manage claims adjudication and patient services, providing a "white glove" service model [17] - Anticipated payer mix includes approximately 60% commercial payers, one-third Medicare, and the remainder Medicaid [18] Pricing and Market Access - Pricing for Molgramostim is expected to be between $400,000 and $500,000 per patient per year, with payers showing understanding of the product's value [19][20] - Prior authorization will likely require proof of diagnosis, with no significant concerns from payers regarding budget impact due to the small patient population [19][23] Diagnostic Testing and Patient Identification - Implementation of a no-cost dry blood spot test for diagnosing autoimmune PAP is ongoing, with high sensitivity and specificity [28][29] - The test aims to identify undiagnosed patients, particularly in ILD clinics, enhancing the understanding of the patient population [30] European Market Strategy - The company plans to independently launch in Europe and the U.K., with a patient population size similar to that in the U.S. [33][34] - The recent financing positions the company well for both U.S. and European launches, with over $260 million in cash and additional royalty financing [35] Advocacy and Awareness - Support groups such as the PAP Foundation and PAP Alliance are active in raising awareness for autoimmune PAP, contributing to patient advocacy efforts [31] Additional Insights - The company emphasizes the importance of hiring experienced personnel for the commercialization of rare disease drugs, particularly in navigating the complexities of the orphan drug market [16] - The long-term strategy includes continuous education for payers and healthcare professionals about the disease burden and the clinical benefits of Molgramostim [19][20]