Core Viewpoint - The company has received approval from the U.S. FDA for its injectable bortezomib abbreviated new drug application (ANDA), indicating that the product is bioequivalent and therapeutically equivalent to the original drug, which enhances the company's international market presence and product pipeline [1][4]. Drug Basic Information - Drug Name: Injectable Bortezomib - Dosage Form: Injection - Specification: 3.5 mg - Approved Indications: - Treatment of multiple myeloma patients who have not received prior treatment and are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1]. - Part of a combination therapy for multiple myeloma patients under 65 years old who have not received prior treatment, used for high-dose chemotherapy with autologous stem cell rescue following induction therapy [1]. - Treatment of multiple myeloma patients who have received at least one prior treatment and whose disease has progressed [2]. - Treatment of adult patients with mantle cell lymphoma who have not received prior treatment, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [2]. Other Drug-Related Information - In April 2024, the product received a drug registration certificate from the National Medical Products Administration of China, indicating it passed the consistency evaluation [3]. - In October 2025, the product obtained marketing authorization from the Australian Therapeutic Goods Administration (TGA) [3]. Impact on the Company - The approval of the injectable bortezomib ANDA by the U.S. FDA signifies that the company's research and production meet original drug standards, showcasing its international research and production capabilities [4]. - This approval enriches the company's international sales product pipeline and advances its internationalization strategy, positively impacting the company's product influence and future operating performance [4]. - The approval grants the drug legal sales rights in the U.S., enhancing the company's market competitiveness and providing a new profit growth point for sustainable development [4].

Group 1 - CICC announced a cash dividend distribution of 434 million yuan for the first half of 2025, with a per-share dividend of 0.09 yuan [10] - Haitian Flavoring proposed a special dividend plan, distributing 3 yuan for every 10 shares, totaling 1.754 billion yuan [16] - Xibu Mining's subsidiary obtained a mining license for a polymetallic mine with a gold metal content of 2.86 tons [2] Group 2 - Qibin Group's subsidiary plans to invest 600 million yuan to establish a new energy company in Shenzhen [2] - Jiangnan New Materials intends to invest 300 million yuan in a high-end copper-based core material R&D and industrialization project [4] - Tibet Pharmaceutical plans to repurchase shares worth 170 million to 200 million yuan for employee stock ownership plans [5] Group 3 - Nanjing Pharmaceutical plans to invest 120 million yuan to establish a medical device investment company [6] - Baotai received acceptance for the marketing application of BAT5906, a drug for wet age-related macular degeneration [7] - Nanhua Futures set the public offering price for H-shares at 12 HKD per share [8] Group 4 - Visionox plans to invest 3.918 billion yuan in the second phase of the Hefei Guoxian AMOLED production line project [9] - Dafu Technology intends to transfer 49% of Daosheng Graphite's equity at a base price of 206 million yuan [9] - Aorite passed the GMP compliance inspection for its production lines [9] Group 5 - Sichuan Road and Bridge reported that China Post Insurance increased its stake to 5% [11] - Huicheng Environmental Protection received approval for a private placement from the CSRC [12] - Junwei Electronics announced a joint venture with Placo New Materials in Hong Kong [13] Group 6 - Huayi Fragrance appointed Gao Ming as the deputy general manager [14] - Yongmota received a government subsidy of 17.2242 million yuan [15] - *ST Shuangcheng's injection of boron substituent has been approved by the FDA [19] Group 7 - Jiemai Technology invested in Beijing Critical Field Technology Co., focusing on high-temperature superconducting materials [20] - Xianju Pharmaceutical's drug registration application for a combination packaging product was accepted [21] - Qinglong Pipe Industry signed a contract worth 55.2671 million yuan for a water diversion project [31]

Core Viewpoint - Hainan Shuangcheng Pharmaceutical Co., Ltd. has received FDA approval for its injectable Bortezomib ANDA, marking a significant milestone in its international expansion and product portfolio enhancement [1] Group 1: Company Performance - As of December 18, 2025, *ST Shuangcheng (002693) closed at 6.58 yuan, down 0.3% from the previous trading day, with a total market capitalization of 2.729 billion yuan [1] - The stock opened at 6.59 yuan, reached a high of 6.79 yuan, and a low of 6.55 yuan, with a trading volume of 32.0879 million yuan and a turnover rate of 1.17% [1] Group 2: Regulatory Approvals - The injectable Bortezomib ANDA has been recognized by the FDA as being bioequivalent and therapeutically equivalent to the reference drug [1] - The product has also received approval from the National Medical Products Administration of China and has passed the consistency evaluation, along with obtaining listing permission from Australia's TGA [1] Group 3: Strategic Implications - The FDA approval signifies that the company's product meets international standards, which is expected to enhance its international influence and operational performance [1] - This development will enrich the company's international sales product line and advance its globalization strategy [1] - The announcement also notes that overseas sales may be affected by regulations, policies, market conditions, and exchange rate fluctuations [1]

Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable bortezomib by the U.S. FDA marks a significant milestone for the company, indicating that its product meets the safety and efficacy standards of the original research level, which is expected to enhance the company's international influence and future operating performance [2]. Group 1 - The company received notification from the U.S. FDA regarding the approval of its ANDA for injectable bortezomib [2]. - The approval signifies that the company's research and production of injectable bortezomib have reached the original research level in terms of safety and efficacy [2]. - This development is anticipated to have a positive impact on the company's international product influence and future business performance [2].

Core Viewpoint - The company *ST Shuangcheng has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for injectable bortezomib, indicating that the product is bioequivalent and therapeutically equivalent to the reference drug [1] Group 1: FDA Approval - The U.S. FDA has completed a comprehensive technical review of the ANDA submitted by the company [1] - The approval confirms that the company's product is equivalent in terms of biological and therapeutic effects to the original drug [1] Group 2: Approved Indications - The approved indications for the injectable bortezomib include: 1. Treatment of previously untreated multiple myeloma patients who are not suitable for high-dose chemotherapy, in combination with melphalan and prednisone [1] 2. Part of a combination therapy for previously untreated multiple myeloma patients under 65 years old, used for high-dose chemotherapy with autologous stem cell rescue following prior induction therapy [1] 3. Treatment for multiple myeloma patients who have received at least one prior therapy and whose disease has progressed [1] 4. Treatment of adult patients with previously untreated mantle cell lymphoma in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [1]

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]

Core Viewpoint - *ST Shuangcheng (002693.SZ) has received marketing approval from the Australian Therapeutic Goods Administration (TGA) for injectable bortezomib, indicating a significant advancement in its product offerings for treating multiple myeloma and mantle cell lymphoma patients [1] Group 1: Product Approval Details - The approved indications for bortezomib include treatment for previously untreated multiple myeloma patients who are unsuitable for high-dose chemotherapy when used in combination with melphalan and prednisone [1] - It is also approved for use in patients under 65 years old with previously untreated multiple myeloma as part of a high-dose chemotherapy regimen combined with autologous stem cell rescue following prior induction therapy [1] - The drug is indicated for patients who have received at least one prior treatment and whose disease has progressed [1] - Additionally, it is approved for adult patients with previously untreated mantle cell lymphoma when used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone [1]