金融界8月24日消息，有投资者在互动平台向贝达药业提问："请问董秘，请介绍一下公司在研的双抗产 品项目进展如何？" 针对上述提问，贝达药业回应称："您好！MCLA-129是一款针对表皮生长因子受体（EGFR）和细胞间 质上皮转化因子（c-Met）双靶点的双特异性抗体，可同时阻断EGFR和c-Met的信号传导，抑制肿瘤的 生长和存活。MCLA-129目前有单药和联用的多项适应症临床研究，今年1月，注射用MCLA-129 I/II期 研究进入了平行队列扩展的II期研究阶段并完成首例受试者入组，目标适应症为野生型结直肠癌；今年 7月，MCLA-129在肺癌领域开展的一项关于驱动基因阳性以及MET扩增相关的II期研究完成首例患者入 组；此外，MCLA-129与贝福替尼联用的药物临床试验正在推进中，MCLA-129与恩沙替尼联用的药物 临床试验申请于近日获得NMPA受理。上述临床研究若有重大进展节点公司会及时公开披露。谢 谢！"责任编辑：钟离 ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

Core Viewpoint - The company Ailis (688578.SH) announced plans for a share reduction by its employee stock ownership platforms due to funding needs, potentially affecting up to 3% of its total shares, corresponding to a maximum value of over 1.2 billion yuan based on recent market capitalization [1][3]. Group 1: Share Reduction Announcement - Ailis plans to reduce up to 13,500,000 shares, representing no more than 3.00% of its total share capital, starting from September 1, 2025 [1]. - The company's market capitalization was reported at 42.5 billion yuan as of August 8, 2023 [1]. Group 2: Employee Stock Ownership Platforms - The shares held by the employee stock ownership platforms were acquired through equity incentives before the IPO, resulting in significant appreciation in value [3]. - The Shanghai Aixiang platform held 10.11% of Ailis prior to the IPO, with an initial investment of 59.57 million yuan, which has appreciated substantially [3]. Group 3: Key Shareholders - Jeffery Yang Guo, a core founder's son, holds 25.6236 million shares valued at approximately 2.422 billion yuan, making him the largest shareholder [3]. - Chairman and General Manager Du Jinhao holds 10.8 million shares valued at around 1.021 billion yuan, ranking him second among shareholders [4]. Group 4: Market Trends - There is a growing trend of share reductions by employee stock ownership platforms in the market, with other companies like United Imaging Healthcare also announcing similar plans [4]. - The stock market has shown positive trends, prompting many companies to liquidate shares through employee platforms [4]. Group 5: Financial Performance - Ailis reported revenues of 790 million yuan, 2.018 billion yuan, and 3.558 billion yuan for the years 2022, 2023, and 2024, respectively, with net profits of 131 million yuan, 644 million yuan, and 1.43 billion yuan [6]. - In Q1 of the current year, Ailis achieved a revenue of 1.098 billion yuan, a 48% year-on-year increase, and a net profit of 410 million yuan, a 34% increase [7]. Group 6: Product Dependency and Competition - Ailis heavily relies on its lung cancer drug, Vomeletinib, which has captured over 80% of the market share in its category, but faces increasing competition from other EGFR TKI products [8][9]. - The competitive landscape includes several other approved products, with Ailis's Vomeletinib projected to generate around 4.5 billion yuan in 2025 [8].

Core Viewpoint - The overdue payment of 180 million yuan by Betta Pharmaceuticals to Yifang Biotech for the innovative lung cancer drug, Beifu Tian, has highlighted the survival pressures faced by both companies and raised concerns about the credit system in the innovative drug industry [1][9]. Group 1: Payment Dispute Details - Yifang Biotech disclosed that Betta Pharmaceuticals has owed 180 million yuan for nearly two years, despite multiple communications and a formal payment reminder sent at the end of 2024 [1][2]. - The cooperation agreement between Yifang Biotech and Betta Pharmaceuticals, established in December 2018, stipulated that Betta would pay a total of 230 million yuan in initial and milestone payments for the drug's development and commercialization [1][2]. - Betta Pharmaceuticals initially paid 55.3 million yuan in 2019, but subsequent milestone payments totaling 180 million yuan were delayed due to claims of "funding arrangements" [2][4]. Group 2: Financial Implications for Yifang Biotech - Yifang Biotech's revenue for 2024 was approximately 169 million yuan, entirely derived from technology licensing and cooperation, making the overdue payment critical for its funding [4][9]. - The company has recognized a bad debt provision of 18 million yuan, reflecting its expectation of non-receipt of the overdue payment [1][4]. Group 3: Financial Condition of Betta Pharmaceuticals - Betta Pharmaceuticals reported a revenue of 2.892 billion yuan and a net profit of 403 million yuan for 2024, with a year-on-year increase of 17.74% and 15.67%, respectively [7][8]. - The company has faced significant cash flow pressures, with a 37.23% decrease in cash reserves to 472 million yuan by the end of 2024, and a current ratio below 1 for three consecutive years [7][8]. Group 4: Market Competition and Challenges - Beifu Tian, as a third-generation EGFR inhibitor, faces intense competition from established products like Osimertinib and Aumolertinib, which has impacted its market performance [5][6]. - The sales performance of Betta's other products has also been under pressure, with significant declines in sales growth and profit margins [5][6]. Group 5: Industry Credit System Concerns - The overdue payment issue has sparked discussions about the credit system in the innovative drug industry, emphasizing the need for transparency and trust in business collaborations [9][10]. - Experts have pointed out the risks associated with unclear contract terms and the importance of financial planning and trust in maintaining long-term partnerships [10].

Core Viewpoint - The overdue payment of 180 million yuan from BeiGene to Yifang Biotech highlights the commercialization challenges and financial pressures faced by innovative pharmaceutical companies in China [1][2]. Group 1: Payment Dispute - BeiGene has failed to pay 180 million yuan in milestone payments to Yifang Biotech over two years, with 80 million yuan due after the approval of a lung cancer drug and 100 million yuan after another indication was approved [2]. - Yifang Biotech did not disclose this significant overdue receivable in its regular reports until questioned by the Shanghai Stock Exchange, revealing a hidden debt situation [2]. Group 2: Market Performance - BeiGene's delay in payments is attributed to its own financial arrangements, but the market performance of its drug, Beifuqunib, is concerning, facing stiff competition from established products like Osimertinib [3]. - Sales data indicates that Beifuqunib's annual sales are only about 100-200 million yuan, significantly lower than competitors, despite being included in the national medical insurance catalog [3]. Group 3: Financial Health - BeiGene's financial difficulties are evident, with cash reserves dropping to 472 million yuan by the end of 2024, a decrease of 280 million yuan year-on-year [4]. - The company's current ratio has been below 1 for three consecutive years, indicating declining short-term debt repayment capacity, with current assets of 1.224 billion yuan insufficient to cover current liabilities of 1.848 billion yuan [4]. Group 4: Industry Challenges - The payment dispute reflects a broader survival dilemma for Chinese biotech firms, with Yifang Biotech projected to have revenues of 169 million yuan in 2024 but losses of 240 million yuan, leading to accounts receivable exceeding revenue [5]. - BeiGene holds five marketed drugs, but three are licensed products, and its proprietary product faces patent expiration, indicating a dual financial strain from research and commercialization [5]. Conclusion - The 180 million yuan overdue payment serves as a mirror reflecting the difficulties faced by Chinese innovative pharmaceutical companies in transitioning from research to commercialization, raising questions about the industry's creditworthiness and cash flow challenges under current market pressures [6].

Core Viewpoint - The delayed payment of 180 million yuan by Betta Pharmaceuticals to Yifang Biologics for milestone payments related to the drug Beifuzi has raised concerns about the financial health and operational integrity of both companies [1][2][5]. Company Overview - Yifang Biologics developed Beifuzi, a first-in-class innovative drug for lung cancer, and granted commercial rights to Betta Pharmaceuticals in December 2018 [2][3]. - Betta Pharmaceuticals was supposed to pay a total of 230 million yuan in milestone payments based on the drug's development progress, which includes regulatory approvals for various treatment indications [2][4]. Financial Performance - Yifang Biologics reported zero revenue from 2020 to 2022, but began generating income in 2023, totaling 186 million yuan, primarily from technical authorization and cooperation [4][8]. - As of the end of 2023, Yifang Biologics had accounts receivable of 186 million yuan, with a provision for bad debts of 9.29 million yuan, indicating reliance on Betta Pharmaceuticals for revenue [4][5]. Payment Delays - Betta Pharmaceuticals has delayed payments for two years, with the outstanding amount of 180 million yuan due to its own financial management considerations [5][10]. - The company has acknowledged the overdue payments and stated that it will fulfill its obligations according to the agreement [5][7]. Market Competition - Beifuzi's market entry is hindered by its later approval compared to competitors like Osimertinib and Alectinib, which have annual sales in the range of 3 to 4 billion yuan [8][9]. - Yifang Biologics has reported sales-related income from Beifuzi of approximately 5.53 million yuan in 2023 and 16.38 million yuan in 2024, indicating a significant gap in sales compared to established competitors [8][9]. Financial Health of Betta Pharmaceuticals - As of the end of 2024, Betta Pharmaceuticals had cash reserves of 472 million yuan, down from 752 million yuan at the beginning of the year, reflecting a decline in liquidity [10]. - The company's current ratio has been below 1 for three consecutive years, indicating a potential decline in short-term solvency [10].

Summary of Yifang Biopharma Conference Call Company Overview - Yifang Biopharma is focused on innovative drug development with a strong pipeline of six key drug candidates, showcasing excellent project initiation and clinical advancement capabilities [8][3][4]. Key Drug Candidates and Market Potential - **EGFR TKI (Befotinib)**: Expected to replace Alectinib and expand market share in the rapidly growing EGFR mutation-targeted therapy market [2][3]. - **KRAS G12C Inhibitor**: Launched in 2024, showing strong sales performance and anticipated peak sales [2][3]. - **TYK2 Inhibitor (D2,570)**: Demonstrated global best-in-class (BIC) potential in psoriasis phase II trials, with a PASI 100 response rate of 50% in high-dose groups, outperforming other oral medications [3][19]. - **URAT Inhibitor**: Aimed at addressing safety issues in gout treatment, currently in phase II trials both domestically and internationally [2][4][7]. Development Strategies - Yifang plans to advance its oral SERD inhibitors through differentiated strategies, including combinations with HER2 ADC or CDK4/6 inhibitors, and aims for external licensing to domestic companies [2][6]. - The URAT inhibitor is designed to provide faster onset and better safety compared to allopurinol, addressing long-standing safety concerns in the gout market [7]. Market Trends and Competitive Landscape - The global psoriasis treatment market is projected to reach approximately $34 billion, with the U.S. market nearing $30 billion [9]. - Oral medications are gaining traction due to patient preferences, with 30% of untreated patients reluctant to use injectable biologics due to injection-related issues [10]. - Major pharmaceutical companies, including AbbVie and Johnson & Johnson, are actively developing oral psoriasis treatments, facing patent expiration pressures on existing products [11]. Future Directions - The future of psoriasis treatment is focused on improving drug convenience and efficacy, with a significant shift towards oral formulations [9][20]. - Yifang's innovative oral TGF-β inhibitors are expected to capture market share rapidly, potentially increasing the current less than 5% market penetration of oral medications in psoriasis [19][20]. Additional Insights - The competitive landscape for TYK2 inhibitors is robust, with multiple companies engaged in active development and partnerships, indicating high commercial value in this segment [16]. - Yifang's D2,570 is positioned to become a leading treatment option in the expanding psoriasis market, with significant therapeutic potential compared to existing therapies [19].

Core Viewpoint - Yifang Biotech (688382.SH) reported a revenue of 169 million yuan for 2024, a year-on-year decrease of 9.02%, while the net loss attributable to shareholders was 240 million yuan, a reduction in loss of 15.41% [1] Financial Performance - The company’s revenue heavily relies on technology licensing and sales commissions, with 96% of revenue coming from these sources [1] - Milestone revenue from Gexolex (格索雷塞) accounted for 151 million yuan (89% of total revenue), while sales commissions from Beifutini (贝福替尼) contributed 16.38 million yuan (9.7%) [1] - The company reported that the revenue from milestone payments is one-time income, leading to significant fluctuations in annual revenue, thus the gross margin is reported as "not applicable" [1] Accounts Receivable - The overdue receivables amount to 180 million yuan, which are milestone payments from Betta Pharmaceuticals (贝达药业) [2] - Betta Pharmaceuticals has delayed the payment due to its own financial arrangements but has committed to fulfilling its payment obligations as per the agreement [2] - Yifang Biotech has made a provision for bad debts of 18 million yuan against the overdue amount, which is considered sufficient [2] Research and Development - R&D investment for 2024 was 384 million yuan, a decrease of 13.22% year-on-year, with a reduction of 36 R&D personnel [2] - The reduction in personnel was attributed to the completion of clinical trials for D-1553 (Gexolex), and the adjustments did not affect key positions or the overall R&D capability of the company [2] Business Outlook - The company has indicated potential risks related to ongoing losses and significant declines in performance, with most products still in clinical development and not yet generating sales revenue [3] - Future profitability is expected to improve as clinical development and commercialization progress, leading to milestone payments and sales sharing [3]

Core Viewpoint - Yifang Biotech (688382) faces significant operational challenges and financial difficulties, with a reported revenue of 169 million yuan and a net loss of 240 million yuan in 2024, marking a 14.5% increase in losses year-on-year [1] Revenue Structure - In 2024, 96% of the company's revenue came from technology licensing and sales commissions, with milestone revenue from Gexolex (151 million yuan, 89%) and sales commissions from Befotizumab (16.38 million yuan, 9.7%) [2] - The company recognizes revenue based on accounting standards, with significant milestone payments being a major component, leading to a "not applicable" gross margin due to the reliance on one-time payments [2] Accounts Receivable and Bad Debt - The overdue milestone payment of 180 million yuan from Betta Pharmaceuticals accounts for 77% of total accounts receivable, raising concerns about the company's ability to recover these funds [3] - The company has made a provision for bad debts amounting to 18 million yuan (10% of the overdue amount), but the recoverability of older receivables remains uncertain [3] Product Challenges - Befotizumab faces pricing pressure from insurance reductions and competition from six similar products already on the market, despite its superior efficacy [4] - Gexolex, while being the second approved product in its category, is projected to have a modest global market growth of 27% from 2023 to 2032, with competition from domestic products [4] R&D Pipeline - The company has a promising oral SERD drug D-0502 for breast cancer in Phase III trials, expected to be approved by 2026, while the URAT1 inhibitor D-0120 for gout is facing delays in clinical trials [5] - R&D investment has decreased by 13% to 384 million yuan, with a reduction of 36 staff members, raising concerns about the potential impact on R&D capabilities [5] Fund Utilization and Future Outlook - The company's fundraising projects have undergone changes, with the headquarters project being adjusted twice, leading to a reduced funding amount and a low utilization rate of 45.31% for new drug development [6] - The company is under pressure to turn a profit, with risks associated with delayed receivables and increased market competition, particularly if later-stage pipelines do not launch on schedule [6]

Core Viewpoint - The company, Yifang Biotechnology, is under scrutiny regarding its financial disclosures and operational performance, particularly concerning its revenue from technology licensing and sales commissions related to its products, Befotertinib and Garsorasib. Group 1: Revenue and Financial Performance - In 2024, the company reported total revenue of 1,637.86 million yuan from sales commissions, a significant increase from 552.69 million yuan in 2023 [21] - The company has received 15,094.34 million yuan in revenue from Garsorasib and 1,637.86 million yuan from Befotertinib, with the latter's revenue confirmed through correspondence with partners [3][6] - The company’s revenue recognition practices align with accounting standards, confirming income upon the transfer of control of the product to customers [4][6] Group 2: Product Details and Market Potential - Befotertinib is a third-generation EGFR tyrosine kinase inhibitor for treating non-small cell lung cancer (NSCLC), with a market potential driven by a large patient base and increasing incidence rates [16][24] - The global market for KRAS G12C inhibitors, including Garsorasib, is projected to grow from 319 million USD in 2023 to 2.748 billion USD by 2032, with a compound annual growth rate of 27.0% [17] - The company has established agreements with partners for milestone payments and sales commissions, with potential earnings from Befotertinib and Garsorasib expected to increase as commercialization progresses [19][22] Group 3: Operational Challenges and Strategies - The company faces challenges with overdue receivables, particularly a 180 million yuan milestone payment from partner BeiDa Pharmaceuticals, which has been delayed due to their financial arrangements [12] - The company is actively pursuing collection of overdue payments and has implemented measures to improve operational performance, including optimizing product pipelines and seeking commercial partnerships [25][26] - Future clinical trials and product developments are underway, with a focus on expanding indications for existing products and enhancing market presence [28][30]