行 业 研 究 / 医 药 生 物 / 证 券 研 究 报 告 医药生物行业周报 集采新规促行业健康发展 2025 年 07 月 22 日 证书编号：S1160517110001 联系人：崔晓倩 电话：021-23586309 【行情回顾】 【本周观点】 2025 年 7 月 15 日，国家组织药品联合采购办公室发布《关于开展第 十一批国家组织药品集中采购相关药品信息填报工作的通知》。总体而 言，"稳临床、保质量、防围标、反内卷"这四大原则，将成为此次集 采的关键词。医药集采新规优化，回应了行业与社会关切，弱化低价 注重质量，有望促进行业健康长远发展。我们建议关注近年上市创新 品种、通过谈判进入医保目录且在协议期内品种；原辅料优质企业； 通过仿制药一致性评价的重点品种。 【风险提示】 医药行业政策风险；研发进展不及预期风险；业绩不及预期风险 挖掘价值 投资成长 强于大市（维持） 东方财富证券研究所 证券分析师：何玮 相对指数表现 -20% -10% 0% 10% 20% 30% 2024/7 2025/1 2025/7 医药生物 沪深300 相关研究 《关注创新投资主线》 2025.07.07 《创新引领医药 ...

本周，A股稳步上攻，创业板指创年内新高，深证成指也创4个月来新高，并逼近年内最高点，科创 50、中证500、中证1000等指数亦创阶段性新高。周成交温和放大至7.73万亿元，为3个月来最大周成交 量。 资金踊跃入市 稀土需求或快速增长 杠杆资金入市踊跃，绝大部分申万一级行业本周都获得融资净买入，其中计算机行业获得逾44亿元净买 入，电子行业获得逾30亿元净买入，机械设备行业、非银金融行业均获得超20亿元净买入，电力设备、 有色金属、医药生物、汽车等行业也获得超10亿元净买入。仅纺织服饰、商贸零售两个行业被小幅净卖 出。 另据Wind数据统计，电子、医药生物、汽车三个行业本周均获得超200亿元主力资金净流入，电力设 备、通信、计算机、有色金属等行业也获得超百亿元净流入，机械设备行业则连续10日获得净流入。非 银金融行业主力资金净流出逾83亿元，公用事业行业净流出逾34亿元，房地产、传媒、银行等行业也都 净流出超20亿元。 展望后市，太平洋证券指出，随着中美贸易谈判利好消息的出现（如英伟达芯片解禁、稀土出口部分放 开等），叠加"反内卷"带来的通胀止跌的期待，股涨债跌后续将持续。自指数向上变盘之后，银行、 AI、创 ...

Core Viewpoint - As of July 18, 160 stocks reached their 52-week highs, with notable performances from China New Economy Investment (00080), Aoyuan Group Equity (02905), and Zhong An Holdings Group (08462) showing high growth rates of 288.89%, 55.28%, and 50.00% respectively [1][2]. Summary by Category 52-Week High Performers - China New Economy Investment (00080) closed at 0.440, with a peak price of 0.700, achieving a growth rate of 288.89% [2]. - Aoyuan Group Equity (02905) closed at 0.218, with a peak price of 0.250, achieving a growth rate of 55.28% [2]. - Zhong An Holdings Group (08462) closed at 0.221, with a peak price of 0.228, achieving a growth rate of 50.00% [2]. - Other notable performers include Hualian International (00969) with a growth rate of 40.13% and Zhongke Bio (01237) with a growth rate of 37.25% [2]. Additional High Performers - Wanma Holdings (06928) closed at 0.550 with a growth rate of 30.43% [2]. - Lepu Biopharma-B (02157) closed at 7.940 with a growth rate of 24.54% [2]. - Other stocks with significant growth include ZhiJianYueDong (06860) at 17.14% and China Jindian Group (08281) at 17.12% [2]. 52-Week Low Performers - The document also lists stocks that reached their 52-week lows, with XI Ernan CO-U (09311) showing a decline of 16.10% [6]. - Other notable declines include XI Ernan CO (07311) at -12.62% and Haotian International Construction Investment (01341) at -5.70% [6].

Company Overview - Antengene is focused on bringing transformative medicines to patients globally, with commercialization in 6 APAC markets and 9 clinical-stage assets[12, 13] - The company raised US$21 million in Series A, US$120 million in Series B, US$97 million in Series C, and US$367 million in its Hong Kong IPO[21] - As of June 30, 2023, Antengene had RMB 1,322 million in cash and bank balances[21, 225] Pipeline Highlights - For CPI-naïve relapsed/metastatic cervical cancer, ATG-008 (Onatasertib) showed an ORR of 53.3% (16/30) and mPFS of 8.41 months[15] - In CPI-treated relapsed/metastatic cervical cancer, ATG-008 (Onatasertib) showed an ORR of 29.4% (5/17)[15] - In treatment-naïve myelofibrosis patients, Selinexor 60 mg + Ruxolitinib achieved SVR35 of 83.3% (10/12) at week 12 and 91.7% (11/12) at week 24 in efficacy evaluable patients[30] - In TP53 Wild-type Endometrial Cancer Patients, Selinexor monotherapy showed mPFS of 27.4 months compared to 5.2 months for placebo, with HR: 0.42[32] Commercial Performance & Partnerships - XPOVIO® achieved RMB 72.0 million in revenue in 2023 1H, a 33.5% increase compared to RMB 54.0 million in 2022 1H[15] - Antengene entered into a commercialization partnership with Hansoh Pharma in the Mainland of China on August 11th[15] - XPOVIO® has covered 130 DTP pharmacies across the Mainland of China and attained 46 urban-customized commercial health insurance listings (Huiminbao) covering over 55 million people[202] - From commercial launch in May 2022 to June 30th, 2023, XPOVIO® accumulated revenue of RMB 222.1 Million[202]

Antengene Pipeline Overview - Antengene is developing a diverse pipeline of oncology and autoimmune programs, including T cell engagers and other novel therapies[9, 10] - The company has partnerships and clinical collaborations to advance its programs[10] - Antengene has USD 125 million in cash and bank balances to advance pipeline development and strategic initiatives over the next 3 years[11] ATG-022 (Claudin 18.2 ADC) - ATG-022 demonstrates efficacy across all CLDN18.2 expression levels in gastric cancer, including low and ultra-low expressors[15, 23, 29] - In CLDN18.2 moderate to high expressing GC (IHC 2+ > 20%), ATG-022 showed an ORR of 40% (12/30) and a DCR of 90% (27/30)[10, 31] - In CLDN18.2 low and ultra-low expressing GC (IHC 2+ ≤ 20%), ATG-022 showed an ORR of 30% (3/10) and a DCR of 50% (5/10)[10, 31] - One patient with complete response (CR) has demonstrated durable CR for over 21 months[32] ATG-037 (CD73 Inhibitor) - The immuno-oncology (IO) market is estimated to be over USD 140 billion in 2028, including IO-resistant tumors[44] - In CPI-resistant melanoma, ATG-037 in combination with pembrolizumab showed an ORR of 36.4% (4/11) and a DCR of 100% (11/11)[10] - In CPI-resistant NSCLC, ATG-037 in combination with pembrolizumab showed an ORR of 22.2% (2/9) and a DCR of 67% (6/9)[10] AnTenGager T Cell Engager (TCE) Platform - AnTenGager is a novel second-generation "2+1" TCE platform with steric hindrance-masking technology[65] - ATG-201 (CD19 x CD3) is a TCE being developed for B cell-related autoimmune diseases, with IND targeting 2025 H2[10, 83]

Investment Rating - The report initiates coverage with a "Buy" rating for the company, targeting a market value of HKD 5.8 billion, which corresponds to a target price of HKD 8.57 [3]. Core Insights - The company has a strong cash flow support from its commercialized product, Selinexor, which has expanded its indications and market presence [2]. - The clinical pipeline includes ATG-022, a differentiated CLDN18.2 ADC, and ATG-037, a CD73 small molecule inhibitor, both showing promising efficacy in treating various cancers [2][3]. - The second-generation TCE platform is expected to enhance safety and efficacy, with the first product, 25H2, submitted for IND [3]. Company Overview - The company focuses on oncology and immunology, with a pipeline that includes one commercialized product and five clinical candidates [8][9]. - Selinexor, the first commercial product, has been approved in multiple Asia-Pacific markets and is expected to see significant revenue growth in 2024 [8][9]. Clinical Pipeline - The company has five clinical-stage assets, including ATG-022 (CLDN18.2 ADC) and ATG-037 (CD73), which are positioned to address unmet medical needs in oncology [11][51]. - ATG-022 has shown efficacy across various CLDN18.2 expression levels in gastric cancer patients, with ongoing clinical trials [34][39]. - ATG-037 is advancing in clinical trials for melanoma and non-small cell lung cancer, demonstrating encouraging safety and efficacy signals [51]. Financial Performance - The company reported a revenue of HKD 92 million in 2024, a 36.7% increase year-on-year, primarily driven by Selinexor's inclusion in the medical insurance directory [23]. - The adjusted annual loss significantly narrowed from HKD 534 million in 2023 to HKD 305 million in 2024, reflecting improved operational efficiency [23]. - Cash reserves at the end of 2024 stood at HKD 900 million, sufficient to support operations for the next three years at the current spending rate [23].

Group 1 - The pharmaceutical sector in Hong Kong is experiencing a strong rally, with notable gains in stocks such as Kailaiying, which rose over 14%, and Sangfor Pharmaceuticals, which increased by 7.6% [1][2] - Sangfor Pharmaceuticals announced a licensing agreement with Pfizer, receiving an upfront payment of $1.25 billion, which significantly boosted investor confidence [1] - The China National Medical Products Administration has accepted a new drug application for cyclosporine eye gel from Zhaoke Ophthalmology, indicating positive regulatory developments in the industry [1] Group 2 - Longcheng Securities expressed optimism about the pharmaceutical sector, citing frequent favorable policies that are expected to lead to a steady recovery in industry sentiment [1] - Morgan Stanley's research report maintains a positive outlook on the Chinese pharmaceutical industry, highlighting supportive policies for innovation and low dependency on U.S. exports, which mitigates risks from geopolitical tensions and uncertainties in U.S. drug pricing [1]

Financial Performance - Revenue increased from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, representing a significant growth of 36.7%[10] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[10] - Net loss for the year decreased from RMB 5,812.83 million in 2023 to RMB 3,192.50 million in 2024[11] - Adjusted net loss decreased from RMB 5,339.04 million in 2023 to RMB 3,046.72 million in 2024, a notable decline of 42.9%[12] - The overall gross profit for the year ended December 31, 2024, was RMB 75.26 million, up from RMB 55.01 million in 2023[62] - The pre-tax loss for the year ended December 31, 2024, was RMB 319.25 million, compared to a loss of RMB 581.18 million in 2023[62] Cost Management - R&D costs decreased from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[10] - Sales and distribution expenses reduced from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of a specific product in the Asia-Pacific region[11] - Administrative expenses decreased from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[11] - Employee costs decreased from RMB 151.7 million in 2023 to RMB 93.6 million in 2024, a reduction of approximately 38.3%[64] - Total sales and distribution expenses fell from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, a decrease of about 61.7%[65] - Administrative expenses decreased from RMB 148.1 million in 2023 to RMB 106.3 million in 2024, representing a reduction of approximately 28.2%[66] Clinical Development and Pipeline - Selinexor (XPOVIO®) received reimbursement approval in South Korea for treating relapsed or refractory multiple myeloma (rrMM) adult patients, effective July 1, 2024[13] - In China, Selinexor was approved for a new indication to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two lines of systemic therapy[13] - The ORR for Onatasertib (ATG-008) combined with toripalimab in cervical cancer patients was reported at 53.3%, with a disease control rate (DCR) of 86.7%[14] - The clinical pipeline includes ATG-022, a Claudin 18.2 antibody-drug conjugate, which is expected to demonstrate strong anti-tumor efficacy across various Claudin 18.2 expression levels[25] - ATG-022 is anticipated to complete additional dose escalation cohorts by 2025 to support its transition to critical development stages[25] - The company is conducting late-stage clinical studies for several candidates, including ATG-008 (onatasertib) in combination with other therapies[44] Strategic Initiatives - The company plans to continue focusing on cost reduction and efficiency improvements in R&D and administrative operations[12] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[21] - The company aims to commercialize first-in-class therapies to meet significant unmet medical needs and improve patient quality of life globally[22] - The company is actively pursuing regulatory approvals in multiple regions, including the US, EU, and Asia, to expand its market presence[40] - The company has established global innovation drug development and commercialization teams in China and the Asia-Pacific region to enhance its market presence[119] Market Expansion - The commercial business achieved significant milestones in 2024, including the approval of a second indication for Hivio® and its inclusion in the national insurance directory, enhancing patient accessibility[28] - The company has received NDA approvals for Hivio® in multiple regions, including mainland China, Australia, and several Southeast Asian countries, indicating strong market expansion efforts[33] - The drug Xivio® (Selinexor) has been included in the Pharmaceutical Benefits Scheme (PBS) in June 2023 for treating adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy[41] - Xivio® was included in the national medical insurance catalog in December 2023, effective January 1, 2024, for treating adult patients with relapsed/refractory multiple myeloma[42] - As of December 31, 2024, Xivio® has received NDA approvals in multiple regions including mainland China, South Korea, Singapore, Australia, Malaysia, Thailand, Taiwan, Hong Kong, Macau, and Indonesia[43] Leadership and Governance - Dr. Mei has extensive experience in oncology research and drug development, having held senior positions at Johnson & Johnson, Novartis, and Celgene, contributing to the development of several blockbuster drugs[81] - The company has a strong leadership team with members holding advanced degrees in medicine and business, enhancing its strategic direction and financial management[83][86] - The board includes members with diverse backgrounds in consulting, investment, and pharmaceutical industries, providing a well-rounded perspective on strategic decisions[84][86] - The company has established a strong governance structure with independent directors to ensure accountability and strategic oversight[88] Financial Position and Liquidity - The company has a cash reserve of RMB 900 million, sufficient to fund pipeline product development for the next three years without additional financing[30] - The company reported a total available reserve of approximately RMB 3,755.0 million as of December 31, 2024, compared to RMB 3,710.5 million in 2023, reflecting an increase of 1.2%[101] - The company maintains a healthy liquidity position, closely monitoring its cash flow to meet funding needs[108] - Cash and bank balances decreased from RMB 1,187.7 million in 2023 to RMB 900.1 million in 2024, a decline of approximately 24.2%[71] - The company has no specific plans for significant investments or capital assets as of December 31, 2024[76] Risks and Challenges - The company has incurred significant net losses since its inception and expects to continue doing so in the foreseeable future, posing a risk of substantial investment loss for potential investors[123] - The future business and financial outlook heavily depend on the successful clinical development and regulatory approval of its clinical and preclinical candidates[127] - The company may face difficulties in identifying and developing new candidate drugs, potentially limiting its resource allocation to more profitable opportunities[127] - The company faces intense industry competition, with rivals potentially achieving commercialization of competitive drugs ahead of it[123] Shareholder Information - The largest customer accounted for 78.6% of the group's revenue, while the top five customers contributed 99.8%[194] - The largest supplier represented 16.7% of the group's procurement, with the top five suppliers making up 51.4%[195] - The total number of shares held by the top five shareholders exceeds 50% of the company's total shares[144] - The independent non-executive directors receive an annual director's fee ranging from $25,000 to $50,000[140] - The company has established service contracts for executive directors with a term of three years, with a two-month notice period for termination[138]

Financial Performance - Revenue increased by 36.7% from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, driven by a 27.4% growth in mainland China[6] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[6] - Net loss decreased by 45.1% from RMB 5,811.83 million in 2023 to RMB 3,192.50 million in 2024[7] - Adjusted net loss decreased by 42.9% from RMB 5,339.04 million in 2023 to RMB 3,045.72 million in 2024, reflecting effective cost reduction strategies[8] - The company achieved a net loss of RMB 319,250,000 in 2024, which is a 45.0% improvement compared to a net loss of RMB 581,183,000 in 2023[46] - The pre-tax loss for 2024 was RMB 144,408,000, significantly reduced from RMB 282,437,000 in 2023[63] - The adjusted loss for the year improved from RMB 533.9 million in 2023 to RMB 304.6 million in 2024, reflecting a reduction of about 43.1%[99] Research and Development - R&D costs reduced by 36.2% from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[6] - The company has made steady progress with its preclinical candidates, including ATG-042, ATG-201, ATG-102, ATG-106, ATG-107, and ATG-110[14] - The new "2+1" T cell engager platform, AnTenGagerTM, has shown steady progress, enhancing efficacy and reducing the risk of cytokine release syndrome (CRS)[15] - The Phase I trials for ATG-101 in treating advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[17] - The company is conducting key clinical trials in the US for its bispecific antibody products[22] - The company has initiated multiple Phase II and III clinical trials for its drug candidates[22] - The company reported an overall response rate (ORR) of 42.9% in a trial for ATN-022 in advanced or metastatic gastric cancer patients[41] Product Development and Approvals - Selinexor received approval for reimbursement in South Korea for treating relapsed or refractory multiple myeloma starting July 1, 2024[9] - New indications for Selinexor were approved in China for treating relapsed/refractory diffuse large B-cell lymphoma in July 2024[9] - The company has received NDA approvals for its product, Cevinostat, in multiple regions including mainland China, Australia, and several Southeast Asian countries[20] - The first commercial product, XPOVIO® (Selinexor), is a selective nuclear export inhibitor approved for multiple myeloma and solid tumors, with exclusive rights in Greater China and several other regions[24] - XPOVIO® received accelerated approval from the FDA for treating adult patients with relapsed/refractory multiple myeloma after at least four lines of therapy[25] - The company has received conditional approval from NMPA for XPOVIO® to treat adult patients with relapsed/refractory DLBCL after at least two lines of therapy[29] - The company has received multiple NDA approvals for its product, Xivio® (Selinexor), in various regions, including approvals in 2021, 2022, and upcoming approvals in 2024 and 2025[44] Cost Management - Sales and distribution expenses decreased by 61.5% from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of Selinexor in the Asia-Pacific region[7] - Administrative expenses fell by 28.2% from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[7] - Research and development costs decreased to RMB 258,912,000 in 2024 from RMB 405,669,000 in 2023, reflecting a 36.3% reduction[45] - Selling and distribution expenses dropped from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, mainly due to the absence of milestone payments and reduced employee costs[94] - Employee costs decreased from RMB 77.5 million in 2023 to RMB 20.5 million in 2024, representing a decline of about 73.5%[96] Market Expansion and Strategy - The company is focusing on expanding its market presence in Greater China, South Korea, Singapore, Malaysia, Indonesia, Vietnam, Laos, Cambodia, the Philippines, Thailand, and Mongolia[22] - The company is exploring new strategies for commercialization and market expansion[22] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[15] - The company is preparing its commercial team for the launch of Xivio® in the Asia-Pacific region to address unmet medical needs[44] Financial Position - The total assets less current liabilities amounted to RMB 1,198,407,000 in 2024, down from RMB 1,427,699,000 in 2023[48] - Cash and bank balances decreased to RMB 900,138,000 in 2024 from RMB 1,187,703,000 in 2023, indicating a liquidity reduction[48] - The company’s total equity decreased to RMB 850,801,000 in 2024 from RMB 1,147,384,000 in 2023, reflecting a decline in shareholder value[48] - The debt-to-asset ratio increased to 36.7% in 2024 from 29.1% in 2023, indicating a rise in leverage[105] Corporate Governance - The audit committee, consisting of three independent non-executive directors, has reviewed the financial performance and confirmed compliance with relevant accounting standards and regulations[120] - The company has maintained a public float of at least 25% of its total issued share capital in accordance with listing rules[124] - The company has adopted the "Standard Code" for securities trading by directors and confirmed compliance throughout the reporting period[114] - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[113]

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 60.8 million, a decrease of 15.6% from RMB 72.0 million for the same period in 2023[3]. - Other income and gains fell to RMB 27.3 million, down RMB 93.8 million from RMB 121.1 million in the prior year, primarily due to a decrease in foreign exchange gains[4]. - Loss for the period narrowed to RMB 167.0 million, a decrease of RMB 51.7 million from RMB 218.7 million in the prior year[5]. - Adjusted loss for the period, excluding the impact of equity-settled share-based payments, was RMB 152.6 million, down RMB 36.8 million from RMB 189.4 million[6]. - Adjusted loss excluding foreign exchange gains was RMB 158.7 million, a significant decrease of 43.7% from RMB 281.7 million in the previous year, driven by effective cost reduction strategies[6]. - The gross profit for the six months ended June 30, 2024, was RMB 51.9 million, compared to RMB 59.4 million for the same period in 2023[33]. - The pre-tax loss for the six months ended June 30, 2024, was RMB 167.0 million, compared to RMB 218.7 million for the same period in 2023[33]. - Total comprehensive loss for the period was RMB 168,242,000, compared to RMB 276,243,000 in the same period last year, showing a 39.2% decrease[86]. - The company reported a net loss of RMB 167,033,000 for the six months ended June 30, 2024, compared to a net loss of RMB 218,694,000 for the same period in 2023, representing a 23.5% improvement[88]. Research and Development - R&D expenses decreased to RMB 130.8 million, down RMB 95.3 million from RMB 226.1 million in the previous year, attributed to improved R&D efficiency[5]. - The company maintains a strategic focus on advancing core R&D programs without engaging in new business development activities during the reporting period[16]. - The company has a pipeline that includes one commercialized product, eight clinical assets, and several preclinical projects, emphasizing a "combination and complementary" R&D strategy[18]. - The product pipeline includes 10 candidates focused on oncology, with various stages from preclinical to late-stage clinical trials[19]. - The company is conducting several late-stage clinical studies for Xivio® (Selinexor), including a Phase III trial in combination with bortezomib and low-dose dexamethasone for relapsed/refractory multiple myeloma[26]. - The latest results from the I/II phase TORCH-2 study of Onatasertib (ATG-008) showed an overall response rate (ORR) of 53.3% and a disease control rate (DCR) of 86.7% in cervical cancer patients who had not previously received checkpoint inhibitors[8]. - The I phase trials of ATG-101 for advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[9]. - The I phase trial of ATG-022 (Claudin 18.2 antibody-drug conjugate) has shown preliminary efficacy data with one complete response (CR) and one partial response (PR) among gastric cancer patients[12]. Cost Management - Selling and distribution expenses were RMB 56.0 million, a reduction of RMB 32.2 million from RMB 88.2 million, mainly due to the absence of milestone payments related to commercialization in the Asia-Pacific region[5]. - Administrative expenses decreased to RMB 58.5 million, down RMB 25.3 million from RMB 83.8 million, primarily due to reduced employee costs[5]. - Employee costs dropped from RMB 86.9 million to RMB 51.3 million, reflecting a decrease of RMB 35.6 million[36]. - The company reported no milestone payments related to commercialization in the Asia-Pacific region for the six months ended June 30, 2024, compared to RMB 21.3 million for the same period in 2023[38]. - The adjusted R&D costs for the six months ended June 30, 2024, were approximately RMB 130.8 million, down from RMB 226.1 million for the same period in 2023[33]. Corporate Governance - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[57]. - The board consists of three executive directors, one non-executive director, and three independent non-executive directors, ensuring sufficient checks and balances[57]. - The company plans to continue reviewing its corporate governance practices to ensure compliance with the Corporate Governance Code[57]. - The company appointed Dr. Mei Jianming as the Chairman and CEO, who has extensive experience in identifying strategic opportunities[55]. - Dr. Zhang Xiaojing, with over 20 years of experience in oncology and pharmaceuticals, was appointed as Chief Medical Officer in December 2022[55]. Market and Product Development - The company successfully integrated its product into the National Medical Insurance Directory in December 2023, leading to necessary price adjustments[4]. - The Korean National Health Insurance Service approved reimbursement for XPOVIO® (Selinexor) for adult patients with relapsed or refractory multiple myeloma (rrMM) effective July 1, 2024[7]. - The China National Medical Products Administration approved a new indication for XPOVIO® (Selinexor) as a monotherapy for adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two lines of systemic therapy[7]. - The company has submitted New Drug Applications (NDAs) for XPOVIO® (Selinexor) in multiple regions including Macau, Malaysia, Thailand, and Indonesia for the treatment of rrMM and rrDLBCL[18]. - The company is advancing its clinical trials globally with partners in various regions[19]. Shareholder Information - As of June 30, 2024, the board of directors and senior executives hold a total of 183,597,994 shares, representing approximately 27.20% of the company[63]. - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[59]. - The company has confirmed compliance with the standards set forth in the "Standard Code" for securities trading by directors throughout the reporting period[58]. - The company has not noted any incidents of employees failing to comply with the "Standard Code" during the reporting period[58]. - The company’s management has seen a significant number of options granted, with 1,020,000 options exercised by a senior executive[73]. Financial Position - Cash and bank balances as of June 30, 2024, were RMB 1,023.7 million, down from RMB 1,187.7 million as of December 31, 2023[43]. - Current assets totaled RMB 1,112.6 million, including cash and bank balances of RMB 1,023.7 million[43]. - The current ratio as of June 30, 2024, was 572.4%, down from 650.6% as of December 31, 2023[44]. - The company’s total liabilities for other payables and accrued items are unsecured and interest-free, with their book value approximating fair value due to their short-term nature[126]. - The company’s total reserves as of June 30, 2024, were RMB 993,608,000, down from RMB 1,713,322,000 as of June 30, 2023[88].