Core Insights - A Chinese original drug, APG-2575 (brand name: Lisatoclax), has broken the nearly decade-long monopoly of multinational pharmaceutical companies in the global anti-cancer drug market, marking a significant shift in the competitive landscape [2][9] - The drug has received conditional approval from the National Medical Products Administration (NMPA) in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic treatment including a BTK inhibitor [2][5] Drug Development Challenges - The Bcl-2 target, discovered in 1985, has only two approved drugs: AbbVie's venetoclax and APG-2575, due to the high difficulty of drug development associated with protein-protein interactions and the need for drugs to penetrate cell membranes and mitochondrial membranes [3][4] - Major pharmaceutical companies have attempted to develop Bcl-2 inhibitors over the past 20 years without success, highlighting the complexity of this target [4] Market Potential - The global targeted apoptosis therapy market is projected to grow at a compound annual growth rate (CAGR) of 24% from 2023 to 2030, reaching a market size of $22 billion by 2030 [6] - The approval of Lisatoclax is expected to change treatment paradigms and expand the market for Bcl-2 inhibitors, especially in combination therapies [6] Commercialization Strategy - The company plans to independently drive the commercialization of Lisatoclax in China, aiming to explore additional indications beyond CLL/SLL [7][8] - The CEO emphasizes the importance of generating profits from product sales to support ongoing research and development, aiming for the company to achieve overall profitability by 2027 [8] Industry Trends - Following the success of APG-2575, other Chinese companies like BeiGene and Innovent Biologics are also developing Bcl-2 inhibitors, indicating a shift towards a new ecosystem of anti-cancer drugs led by Chinese enterprises [9]

Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement of 22 million ordinary shares, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization and global clinical development efforts in the biopharmaceutical sector [1][2]. Group 1: Offshore Placement Details - The offshore placement involved the sale of 22 million ordinary shares at a price of HKD68.60 per share, with the shares representing approximately 6.29% of the company's issued share capital prior to the placement [1]. - The net proceeds from the placement will be utilized for commercialization efforts, global clinical development of core pipeline candidates, and strengthening global operations [2]. Group 2: Regulatory and Transactional Aspects - The offshore placement was conducted outside of the United States and was not offered to the public, complying with Regulation S under the Securities Act of 1933 [3]. - The Replacement Shares will be issued in a transaction not involving a public offering, and the securities have not been registered under the Securities Act [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [7].

Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization efforts and global clinical development [1][2]. Group 1: Offshore Placement Details - The company closed an offshore placement involving the sale of 22 million ordinary shares at HKD68.60 per share, with the shares representing about 6.29% of the company's issued share capital prior to the placement [1]. - The vendor, an affiliate of the CEO, will subscribe for the same number of new shares at the same price, resulting in net proceeds for the company [1]. - The issuance of the new shares is expected to occur by July 28, 2025 [1]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a robust pipeline of innovative drug candidates [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [7].

Core Viewpoint - As of July 15, 2023, AAPG's stock price increased by 2.27% to $37.02 per share, with a total market capitalization of $3.23 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][3]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases. The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - The company has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway. AAPG has established a pipeline of nine Class 1 small molecule new drugs in clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe. Its core product, Orebate (brand name: Nairike), has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has been approved for sale in China [2]. Regulatory and Collaborative Achievements - The product Nairike has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China. It has also received fast track designation, orphan drug designation from the FDA, and orphan drug designation from the EU [2]. - AAPG has four investigational new drugs that have received 16 FDA orphan drug designations, two FDA fast track designations, and two FDA designations for pediatric rare diseases [2]. - The company has undertaken several national science and technology major projects, including five projects under the "Major New Drug Creation" initiative and one project for "Enterprise Innovative Drug Incubation Base" [2]. Research and Development Capabilities - AAPG has established a strong international talent team with extensive experience in original drug research and clinical development. The company is also building a high-standard commercialization and marketing team [2]. - The company aims to enhance its R&D capabilities and accelerate the clinical development of its product pipeline to meet unmet clinical needs for patients in China and globally [2].

Group 1 - The company, Ascentage Pharma, announced a plan to issue up to 22 million shares through a placement, with a price of HKD 68.6 per share, aiming to raise approximately HKD 1.51 billion [1]

Core Viewpoint - Ascentage Pharma Group International Inc. has announced the pricing of an offshore placement of 22 million ordinary shares, raising approximately HKD1,509.2 million (around US$192.3 million) to support its commercialization and global clinical development efforts in cancer treatments [1][3]. Group 1: Offshore Placement Details - The placement shares are priced at HKD68.60 per share and the offering was oversubscribed by eight times, with the transaction expected to close on July 17, 2025 [1][2]. - The vendor, an affiliate of the CEO, will subscribe for 22 million new ordinary shares at the same price, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [6]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing global registrational Phase III trials [7]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [8][9].

交易文件显示，亚盛医药寻求通过先旧后新方式配股，筹资至多15.4亿港元（1.96亿美元）。将配售 2,200万股股份，配售价为每股68.35-70港元，较周一收盘价74.70港元折让6.3%-8.5%。（彭博） ...

Core Viewpoint - Ascentage Pharma Group International Inc. is conducting an offshore placement of ordinary shares to raise funds for commercialization, clinical development, and operational strengthening [1][2]. Group 1: Offshore Placement Details - The Dajun Yang Dynasty Trust, affiliated with the CEO, will offer ordinary shares in an offshore transaction to non-U.S. persons under Regulation S of the Securities Act [1]. - The Vendor will subscribe for new ordinary shares equal to the number of Placement Shares offered, at the same price per share [1]. - The transaction is subject to customary closing conditions and will occur after the Offshore Placement [1]. Group 2: Use of Proceeds - The net proceeds from the Offshore Placement will be utilized for commercialization efforts, expanding patient access, global clinical development of core pipeline candidates, and enhancing infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is approved in China for treating specific types of chronic myeloid leukemia (CML) and is undergoing a global Phase III trial [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global Phase III trials [7]. Group 4: Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as research institutions like Dana-Farber Cancer Institute and Mayo Clinic [8].

Core Viewpoint - The approval of the new Bcl-2 selective inhibitor, Lisengmato, by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, making it the first domestically developed Bcl-2 inhibitor to be conditionally approved for marketing and the second globally [2][3]. Group 1: Product Development and Market Position - Lisengmato is an oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore the normal apoptosis process in tumor cells, thereby treating tumors [2]. - The approval of Lisengmato highlights Ascentage Pharma's strong innovation capabilities and establishes its leading position in the hematological oncology field [4]. - The company has been engaged in Bcl-2 target drug development for over 30 years, indicating deep expertise in this area [2]. Group 2: Clinical Relevance and Market Need - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) is a prevalent blood cancer in aging populations, with an increasing incidence in China despite lower rates compared to Europe and the U.S. [3]. - The introduction of Bcl-2 inhibitors like Lisengmato addresses unmet clinical needs in the treatment of CLL/SLL, providing new therapeutic options for patients facing challenges such as drug resistance and complex long-term management [3]. - Ascentage Pharma is conducting four global Phase III clinical trials for Lisengmato, indicating ongoing commitment to expanding its clinical applications [4].

Core Viewpoint - The approval of the novel Bcl-2 inhibitor, Lisatoclax (APG-2575), by the National Medical Products Administration (NMPA) in China marks a significant milestone for Ascentage Pharma, as it becomes the first domestically developed Bcl-2 inhibitor approved for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China and the second globally [1][2]. Group 1: Product Approval and Significance - Lisatoclax is the first Bcl-2 inhibitor approved in China for CLL/SLL, highlighting its potential in the treatment landscape [2][3]. - The drug is expected to restore normal apoptosis in tumor cells by selectively inhibiting the Bcl-2 protein, offering new treatment options for patients [2][3]. - The approval signifies Ascentage Pharma's commitment to global clinical innovation and represents a key milestone in its journey to enter the global market [2]. Group 2: Clinical Research and Development - Ascentage Pharma is conducting four global Phase III clinical trials for Lisatoclax, targeting various patient groups, including those with previously treated CLL/SLL and newly diagnosed acute myeloid leukemia (AML) [2]. - The ongoing studies include the GLORA study for treated CLL/SLL patients and GLORA-2 for treatment-naive CLL/SLL patients, among others [2]. Group 3: Challenges in Bcl-2 Inhibition - The development of Bcl-2 inhibitors has been challenging due to the complex nature of protein-protein interactions and the need for drugs to penetrate cellular membranes and mitochondrial membranes [3]. - Prior to Lisatoclax, no Bcl-2 inhibitors had been approved for CLL/SLL treatment in China, indicating a significant advancement in addressing this treatment gap [3].