Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index declined by 3.65% during the reporting period, ranking 21st among 31 primary industries, underperforming the CSI 300 index which fell by 2.73% [4][16] - The valuation of the pharmaceutical and biotechnology industry as of October 17, 2025, is a PE (TTM overall method, excluding negative values) of 30.08x, down from 31.23x in the previous period, indicating a downward trend and below the average [4][21] - Key sub-industries include vaccines (55.76x), hospitals (39.64x), and medical devices (38.84x), with the lowest valuation in pharmaceutical circulation (14.29x) [4][21] - The report highlights significant innovations presented at the 2025 ESMO conference, indicating a shift in global oncology drug development from "single-agent breakthroughs" to "combination therapy strategies" [6][8] - The newly released regulations by the State Council aim to standardize clinical research pathways, promoting innovation while ensuring safety [7][25][26] Industry Overview - The report notes that 26 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 501 million yuan, while 4 companies increased their holdings by 519 million yuan [4] - The report emphasizes the importance of monitoring third-quarter earnings to validate the fundamentals of companies, particularly those with innovative product launches and significant performance improvements [8] Important Industry News - The approval of the first domestic PDE4 inhibitor by He Mei Pharmaceutical marks a significant milestone in the industry [6][34] - The approval of a new indication for GSK's recombinant shingles vaccine expands its application to adults at increased risk due to immunodeficiency [6][36] - The U.S. Senate passed a revised version of the Biosecurity Act, which continues to impose restrictions on certain Chinese biotechnology companies [6][44] - The collaboration between Bai Li Tian Heng and BMS on the iza-bren project has reached a milestone, triggering a payment of 250 million USD [6][47] - The IPO of Xuan Zhu Biotechnology on the Hong Kong Stock Exchange saw a significant oversubscription and a substantial increase in share price during the dark trading period [6][49]

Core Viewpoint - The company is preparing for the production of injectable bortezomib, which has not yet been officially launched in the market [1] Group 1: Company Response - The company addressed investor concerns regarding the impact of the original drug (bortezomib) from Johnson & Johnson/Takeda on its operations [1] - The company indicated that injectable bortezomib is currently in the pre-production stage [1] Group 2: Market Position - The company was asked about the market share of other generic drug companies in the local market [1] - The company provided no specific details on its market share in the Australian market [1]

Core Points - The company has received marketing authorization for injectable bortezomib from the Australian Therapeutic Goods Administration (TGA) [1][4] - The product is indicated for multiple myeloma and mantle cell lymphoma treatment in specific patient populations [2][3] Drug Information - Product Name: Injectable Bortezomib - Dosage Form: Injection - Specification: 3.5 mg - Approved Indications: - Treatment of previously untreated multiple myeloma patients who are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1] - Part of combination therapy for previously untreated multiple myeloma patients under 65 years old, for high-dose chemotherapy with autologous stem cell rescue [1] - Treatment for multiple myeloma patients who have received at least one prior therapy and have disease progression [2] - Treatment for adult patients with previously untreated mantle cell lymphoma in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [2] Impact on the Company - The approval signifies the product's eligibility for sale in Australia, positively impacting the company's overseas market expansion and performance [4] - The export business may face uncertainties due to market demand fluctuations, policy changes, exchange rate volatility, and market competition [4]

Core Viewpoint - *ST Shuangcheng has received marketing approval from the Australian Therapeutic Goods Administration (TGA) for injectable bortezomib, indicating a significant advancement in its product portfolio and potential market opportunities in treating multiple myeloma and mantle cell lymphoma patients [1] Summary by Categories Product Approval - The company has obtained a marketing license for injectable bortezomib from the TGA [1] - The approved indications include treatment for previously untreated multiple myeloma patients who are unsuitable for high-dose chemotherapy, as well as those who have received at least one prior treatment and have disease progression [1] Treatment Combinations - Bortezomib is approved for use in combination with melphalan and prednisone for treating previously untreated multiple myeloma patients [1] - It is also indicated for use in conjunction with high-dose chemotherapy and autologous stem cell rescue for patients under 65 years old who have not received prior treatment [1] - Additionally, it is approved for use with rituximab, cyclophosphamide, doxorubicin, and prednisone for treating adult patients with previously untreated mantle cell lymphoma [1]

格隆汇10月13日丨*ST双成(002693.SZ)公布，近日收到澳大利亚药物管理局（TGA）签发的注射用硼替 佐米的上市许可，获批适应症：（1）与美法仑和泼尼松联合使用，适用于治疗既往未接受过治疗且不 适合接受大剂量化疗的多发性骨髓瘤患者。（2）作为联合治疗的一部分，适用于65岁以下既往未接受 过治疗的多发性骨髓瘤患者，用于高剂量化疗联合自体干细胞挽救之前的诱导治疗。（3）适用于至少 接受过一次既往治疗且疾病进一步发展的多发性骨髓瘤患者。（4）与利妥昔单抗、环磷酰胺、多柔比 星和泼尼松联合使用，适用于既往未接受过治疗的套细胞淋巴瘤成人患者的治疗。 ...

Group 1 - The company *ST Shuangcheng (002693.SZ)* confirmed that several of its products have passed the consistency evaluation for generic drugs [2] - The products that have achieved this include Thymosin injection, Somatostatin injection, Octreotide injection, and Bortezomib injection [2]