Investment Rating - Maintain BUY rating for Innovent Biologics with a target price raised from HK$55.21 to HK$57.67, reflecting a potential upside of 62.4% from the current price of HK$35.50 [1][9]. Core Insights - Innovent Biologics has out-licensed global rights of DLL3 ADC (IBI3009) to Roche, receiving an upfront payment of US$80 million and potential milestone payments up to US$1.0 billion, along with tiered royalties on net sales [1]. - The DLL3 ADC is a promising therapy for pre-treated extensive-stage small cell lung cancer (ES-SCLC), with DLL3 being a neuroendocrine-specific antigen expressed in 85% of SCLC cases [1]. - Innovent has a rich pipeline of innovative drug candidates, including IBI115 (DLL3/CD3 bispecific antibody) and IBI363 (PD-1/IL-2), which have shown encouraging clinical results [1]. Financial Summary - Revenue is projected to grow from RMB 6,206 million in FY23A to RMB 10,840 million in FY25E, representing a year-on-year growth of 32.4% and 31.9% respectively [8][19]. - Net profit is expected to improve from a loss of RMB 1,028 million in FY23A to a profit of RMB 281 million in FY25E [19]. - R&D expenses are forecasted to increase from RMB 2,228 million in FY23A to RMB 3,035 million in FY25E, indicating continued investment in innovative drug development [19]. Drug Development and Pipeline - DLL3 ADC represents a significant advancement in the treatment of SCLC, with various strategies targeting DLL3 being explored, including ADCs and bispecific antibodies [1]. - Innovent's next-gen immuno-oncology asset, IBI363, has shown promising results in multiple cancer types, indicating strong potential for future out-licensing opportunities [1]. - The company has multiple ADC assets in clinical stages targeting various antigens, enhancing its global market potential [1].

财联社1月2日讯（记者 何凡） 经历海外资产风波后，信达生物(01801.HK)国际化的脚步却没有停歇， 与罗氏制药达成新一代抗DLL3抗体偶联药物（IBI3009）的全球独家许可协议，该笔BD交易中里程碑 付款最高可达10亿美金。而在今日二级市场上，公司却未获得正向反馈，有业内人士在接受财联社记者 采访时表示，此次交易金额"中规中矩，不算特别惊艳。" 此前，信达生物曾因"低价贱卖"其子公司Fortvita的股权给公司管理层控股的公司，而备受投资者质 疑，。对此，公司曾一度表示，Fortvita并非优质资产。但此次与罗氏授权交易中，Fortvita Biologics (Singapore) 却以签约方之一的身份出现，在信达生物未来国际化道路中，Fortvita将扮演怎样的角色尚 有待观察。 超10亿美元BD交易难挽二级市场颓势 今日，信达生物宣布与罗氏制药就IBI3009达成全球独家合作与许可协议，授予罗氏IBI3009的全球开 发、生产和商业化的独家权益。 根据协议，双方将共同负责该ADC候选药物的早期开发，后续临床开发将由罗氏负责。信达生物将获 得8000万美金的首付款，和最高达10亿美金的开发和商业化 ...

Core Insights - Lung cancer, particularly non-small cell lung cancer (NSCLC), has high global incidence and mortality rates, with NSCLC accounting for about 85% of all cases. In China, approximately 2.6% of NSCLC patients are ROS1-positive [1][3] - DOVBLERON® (taletrectinib) has been approved by China's National Medical Products Administration (NMPA) for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously been treated with ROS1 TKIs, marking it as the 13th addition to Innovent's commercial portfolio [10][14] - The approval is based on positive results from the TRUST-I trial, which demonstrated DOVBLERON®'s efficacy, particularly in patients with brain metastases and those who have developed resistance to prior therapies [11][12] Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for oncology and other major diseases, with a strong pipeline of targeted therapies [10][16] - The company has established partnerships with over 30 global healthcare companies, enhancing its capabilities in drug development and commercialization [16] Product Details - DOVBLERON® is a next-generation ROS1 inhibitor designed for advanced ROS1-positive NSCLC, with a favorable safety profile and low rates of dose reduction due to adverse events [4][11] - Taletrectinib has received Orphan Drug Designation and Breakthrough Therapy Designations from the U.S. FDA and China's NMPA, indicating its potential to address unmet medical needs in this patient population [5][14]

Core Viewpoint - Innovent Biologics has announced the inclusion of SINTBILO® and a new indication for olverembatinib in the updated 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025, enhancing treatment options for patients in China [1][4]. Group 1: SINTBILO® (Tafolecimab Injection) - SINTBILO® is newly listed in the NRDL for treating adult patients with primary hypercholesterolemia and mixed dyslipidemia, marking Innovent's first entry into the cardiovascular field [2][6]. - The drug offers multiple dosing options: 150mg every two weeks, 450mg every four weeks, and 600mg every six weeks, significantly reducing low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lipoprotein a (Lp(a)) by nearly 50% [2][5]. - As the first domestic PCSK9 inhibitor included in the NRDL, SINTBILO® provides a crucial new treatment option for cholesterol management in China [2][4]. Group 2: Olverembatinib - The updated NRDL includes a renewed indication for olverembatinib, which treats adult patients with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation, and those resistant or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs) [3][8]. - Olverembatinib is recognized as the first third-generation BCR-ABL inhibitor approved by China's National Medical Products Administration (NMPA) [3][7]. - Innovent and Ascentage Pharma are committed to the commercialization of olverembatinib in the Chinese market [9]. Group 3: Company Mission and Future Outlook - The company aims to empower patients with affordable, high-quality biopharmaceuticals, focusing on oncology, cardiovascular and metabolic diseases, autoimmune conditions, and ophthalmology [4][10]. - Innovent has launched 11 products and has 5 new drug applications under regulatory review, with ongoing clinical trials for additional therapies [10]. - The company emphasizes a patient-centered approach to improve drug affordability and accessibility, contributing to better patient care [4][10].

Core Insights - Innovent Biologics is set to present nearly 10 accepted clinical data on its novel oncology molecules at the ESMO Asia Congress 2024, highlighting the updated Phase 1 results of its TOPO1i CLDN18.2 ADC (IBI343) for previously-treated pancreatic cancer [1][4] Group 1: Clinical Data Presentation - The presentation will include a mini oral session on the updated results from a Phase 1 study of IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC) [2] - Other studies to be presented include a Phase 2 study of mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in locally advanced MSS CRC and various Phase 2 studies on treatments for advanced colorectal cancer and hepatocellular carcinoma [2][3] Group 2: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for oncology, cardiovascular, metabolic, autoimmune, and ophthalmology diseases [5] - The company has launched 11 products and has 5 new drug applications under regulatory review, with 3 assets in Phase III or pivotal clinical trials and 17 molecules in early clinical stages [5] - Innovent collaborates with over 30 global healthcare companies, including Eli Lilly and Sanofi, to enhance its research and development capabilities [5]

Investment Rating - The report maintains a "BUY" rating for Innovent Biologics with a target price of HK$55.21, representing a 39.6% upside from the current price of HK$39.55 [3][19]. Core Insights - Innovent Biologics has demonstrated strong fundamentals supported by significant R&D catalysts and a commitment to corporate governance, as evidenced by the cancellation of a related-party transaction to protect investor interests [1][5]. - The company has shown robust product sales growth, with total product sales increasing over 40% year-on-year to more than RMB2.3 billion in Q3 2024, and a total of over RMB6.0 billion in the first nine months of 2024 [6][11]. - Innovent's product portfolio is expanding, with 11 marketed products and the anticipated approval of additional products, aiming for RMB20 billion in sales by 2027 [11][12]. Financial Performance - For FY24E, Innovent is projected to achieve revenue of RMB8.219 billion, reflecting a year-on-year growth of 32.4% [2][18]. - The company expects to narrow its non-IFRS EBITDA loss significantly, projecting a loss of RMB731 million for FY24E, with a target to achieve EBITDA breakeven by 2025 [11][19]. - R&D expenses are forecasted to be RMB2.795 billion in FY24E, indicating a continued investment in innovation [2][19]. Product Pipeline and Market Potential - Innovent's leading product, sintilimab, achieved sales of US$150 million in Q3 2024, with expectations to reach RMB3.69 billion in 2024, a 34% increase year-on-year [6][11]. - The company is advancing several innovative drug candidates, including IBI363 and IBI343, which have shown promising results in clinical trials and are expected to create significant out-licensing opportunities [13][14]. - The anticipated approval of mazdutide for obesity and diabetes in 2025 is expected to enhance Innovent's position in the cardiovascular and metabolic sector [12][15]. Market Outlook - Innovent aims to leverage its strong commercial capabilities and broad product portfolio to drive growth in both domestic and international markets [1][11]. - The company is well-positioned to capture market share in the rapidly growing sectors of oncology and metabolic diseases, with a focus on innovative therapies that address unmet medical needs [12][15].

Core Viewpoint - On November 3, 2023, Innovent Biologics announced the termination of the subscription agreement between Lostrancos and Fortvita, following a significant drop in market value of approximately HKD 15 billion over four consecutive days [1][2] Group 1: Company Actions and Responses - The company reiterated its positive vision for international business development and decided not to proceed with the subscription due to mixed feedback from shareholders [1][2] - CFO You Fei stated that Fortvita currently has no financing plans and expressed a willingness to consider investor opinions for more acceptable methods of supporting international development [1][2] - Following the announcement, Innovent's stock price surged by 8.99% to HKD 38.200 per share, with a market capitalization of HKD 62.5 billion [1] Group 2: Financial Details and Market Reactions - The initial subscription involved a capital increase by management through Lostrancos to Fortvita, acquiring 12.8083 million new Pre-A series preferred shares for USD 20.5 million, valuing Fortvita at a net asset basis with no premium [2] - Investors raised concerns about the perceived undervaluation of Fortvita, which holds significant assets that are currently under development [2] - Innovent's product revenue exceeded RMB 2.3 billion in Q3 2023, marking a year-on-year growth of over 40%, with total revenue for the first three quarters of 2024 reaching RMB 6.111 billion, surpassing the full-year revenue of RMB 5.728 billion in 2023 [4] Group 3: Product Pipeline and Market Position - Fortvita has applied for patents related to several key pipelines, including Claudin18.2/CD3 bispecific antibody (IBI389), Claudin18.2 ADC (IBI343), and PD-1/IL-2 bispecific antibody (IBI363), all of which are in the oncology field [3] - IBI363 is noted as a first-in-class product with promising Phase I trial data and is currently undergoing Phase II trials in the U.S., having received FDA fast track designation for melanoma [3] - The company plans to launch four products by 2025, including those in collaboration with partners, ensuring a steady pipeline for future growth [4]

Investment Rating - The report maintains a "Buy" rating for the company with a target price adjusted to HKD 42.45 [2][3][10]. Core Insights - The company has shown impressive product sales performance, with a revenue increase of over 40% year-on-year to RMB 2.3 billion in the third quarter, driven by strong sales of its oncology drug, Dabu Shu, and the introduction of a new lung cancer drug, Dabu Te [1][2]. - The company is expected to maintain rapid revenue growth, with a projected annual revenue increase of 43.1% to RMB 8.2 billion for the full year [1]. - Concerns have been raised regarding the company's governance, particularly related to the lack of transparency in the announcement of the sale of a 20.39% stake in its subsidiary Fortvita, which is intended to support international business efforts [1][2]. Financial Summary - The company’s total revenue for 2024 is forecasted at RMB 8.459 billion, with growth rates of 36.2% and 36.3% expected for 2025 and 2026, respectively [2][7]. - Shareholder net loss for 2024 is projected to be RMB 708 million, with a return to profitability expected in 2025 and 2026, with net profits of RMB 1.9 billion and RMB 4.5 billion, respectively [2][7]. - The company’s cash flow projections indicate a gradual improvement, with free cash flow turning positive in the coming years [5][7]. Market Performance - The stock closed at HKD 33.80, with a market capitalization of HKD 55.284 billion and a circulating share ratio of 84.94% [3][10]. - The stock has traded within a 52-week range of HKD 28.3 to HKD 52.15, indicating volatility in market sentiment [3][10]. Valuation Metrics - The report adjusts the DCF model's beta coefficient to 1.1 and the WACC to 8.2%, reflecting governance risks [2][5]. - The intrinsic value per share is estimated at HKD 42.45, aligning with the target price set by the report [5][6].

Company Overview - Innovent Biologics (01801 HK) experienced a significant market value drop of over HKD 17 billion (approximately RMB 15 57 billion) in the first four trading days of the week despite releasing a strong earnings report [1] - The company's stock rebounded on the last trading day of the week after a controversial transaction involving the purchase of a subsidiary's shares by the chairman at a perceived low price [1] Controversial Transaction - The chairman and CEO Yu Dechao through his company Lostrancos acquired 20 39% of Fortvita a subsidiary of Innovent Biologics for USD 20 5 million (approximately RMB 146 million) diluting Innovent's stake to 79 61% [1] - The transaction was valued using the net asset method with Fortvita's total assets valued at approximately USD 234 million and total liabilities at USD 154 million resulting in a valuation of USD 80 026 million [2] - Investors were concerned about the lack of premium based on future development expectations as the valuation was essentially the total assets minus total liabilities [2] Market Reaction - The stock price of Innovent Biologics fell for four consecutive trading days starting from October 28 despite the company reporting a 40% year-over-year increase in total product revenue to over RMB 2 3 billion in Q3 [3] - The company's market value dropped from HKD 72 377 billion to HKD 55 284 billion by October 31 before slightly recovering to HKD 57 329 billion on November 1 [4] Management Response - Yu Dechao apologized for not communicating the related-party transaction with investors earlier and emphasized the early-stage nature of Fortvita's pipeline assets [5] - The management explained that using their own funds to invest in Fortvita demonstrated their commitment to internationalization and avoided further dilution of the company's shares [5] - The CFO You Fei stated that the valuation of Fortvita was based on an independent third-party assessment reflecting the current state of the assets [5] Internationalization Strategy - Fortvita holds the overseas rights to several promising R&D products including IBI363 and IBI343 with IBI363 recently receiving Fast Track designation from the US FDA [3] - The company has been focusing on international expansion as a key strategy for revenue generation with Fortvita serving as the platform for overseas business [2] - Despite the challenges Innovent Biologics has a cash reserve of approximately RMB 10 1 billion as of the end of June which may support its international expansion efforts [6] Challenges in Overseas Markets - Innovent Biologics has faced setbacks in its internationalization efforts including the rejection of its PD1 drug sintilimab by the US FDA in early 2022 [7] - The company has not yet achieved Proof of Concept (POC) recognition from the FDA for any of its overseas assets [7] - Some high-potential products such as CD47 and TIGIT have been removed from the company's pipeline due to lack of progress [7]

财联社10月30日讯（编辑 冯轶） 近日，港股生物医药明星个股信达生物(01801.HK)因深陷"资产贱 卖"舆论漩涡持续受到市场关注，公司股价也连续重挫。 截至10月30日收盘，信达生物连续3个交易日走低，累跌约20%，市值蒸发超过140亿港元。而这一切仅 仅是源于一桩约合1.6亿港元的收购交易。 公告发布后，这笔交易迅速引来市场和公司小股东的质疑。 一方面，由管理层收购上市公司资产本身就涉及关联交易，但信达生物甚至没有提前举行股东大会进行 商议，便直接公告。 另一方面，资料显示Fortvita作为信达生物推动国际业务的平台，承担着市场对公司业务出海的预期。 据了解Fortvita目前还持有信达生物研发管线中PD-1/IL2α融合蛋白IBI363的部分海外权益。9月4日， IBI363刚刚获得美国FDA授予快速通道资格。信达生物正在中国、美国、澳大利亚同时开展临床研究。 更令市场不解的是，本次收购标的资产Fortvita的估值采用的是净资产价格。这也意味着，本次交易中 收购方基本不需要支付任何溢价，从而也引发了市场关于"贱卖资产"的担忧。 面对市场的诸多质疑，信达生物在10月29日举行的"中信建投医药|信达 ...