Core Viewpoint - BeiGene's A-share stock price surged by 9.84% on September 2, 2023, reaching a market capitalization of 507.4 billion yuan, marking the first time it surpassed 500 billion yuan, making it the highest-valued pharmaceutical stock in A-shares [1] Group 1: Financial Performance - In the first half of 2025, BeiGene achieved revenue of 17.518 billion yuan, a year-on-year increase of 46%, and a net profit of 450 million yuan, marking its first profit driven by product sales rather than external licensing [1][3] - The primary contributors to this profitability were the self-developed products, Brukinsa (Zebutinib) and Tislelizumab, along with sales growth from Amgen's licensed products [3] Group 2: Product Dependency and Market Concerns - BeiGene's revenue heavily relies on Brukinsa, which generated 12.527 billion yuan, accounting for 72% of total revenue, raising concerns about its ability to maintain high growth amid intense competition in the BTK market [3] - The company is enhancing its competitive edge in the hematological oncology field with two late-stage products: Sotorasib (BCL2 inhibitor) and a first-in-class BTK CDAC [3][4] Group 3: Future Prospects - Sotorasib's application for treating relapsed/refractory chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma has been accepted in China and is under priority review, with plans to submit applications in the US and other global markets in the second half of 2025 [4] - BeiGene aims to initiate a Phase III head-to-head trial for BTK CDAC against a competitor's BTK inhibitor in the second half of 2025, with confidence in establishing a sustainable product portfolio in the $12 billion global chronic lymphocytic leukemia market [4]

Core Viewpoint - BeiGene's A-share stock price surged by 9.84% on September 2, reaching a market capitalization of 507.4 billion yuan, making it the highest-valued pharmaceutical stock in A-shares [2][3] Company Performance - This marks the first time BeiGene's A-share market value has surpassed 500 billion yuan [3] - Since 2025, BeiGene's A-share stock price has doubled, indicating a strong recovery in the pharmaceutical sector after a period of adjustment [4] - In the first half of 2025, BeiGene reported revenue of 17.518 billion yuan, a year-on-year increase of 46%, and a net profit of 450 million yuan, marking its first profit driven by product sales rather than external licensing [4] Product Highlights - The company's profitability is primarily attributed to its self-developed products, namely Baiyueze (Zebutinib) and Baizean (Tislelizumab), as well as sales growth from Amgen's licensed products [4] - Baiyueze is recognized as the globally approved BTK inhibitor with the widest range of indications, generating 12.527 billion yuan in revenue, accounting for 72% of the company's total revenue [4] Market Concerns - There are concerns regarding BeiGene's heavy reliance on Baiyueze and its ability to maintain high growth in a competitive BTK market [5] - The company is enhancing its competitive edge in the hematological oncology field with two late-stage products: Sotokura (BCL2 inhibitor) and a first-in-class BTK CDAC [5] - The company plans to submit a marketing application for Sotokura in China and aims to initiate a Phase III head-to-head trial for BTK CDAC in the second half of 2025 [5] Future Outlook - BeiGene expresses confidence in establishing a sustainable product portfolio in the global chronic lymphocytic leukemia market, projected to reach 12 billion USD, through the synergy of Baiyueze, Sotokura, and BTK CDAC [5]

Core Viewpoint - The article highlights the significant rise in the stock price and market capitalization of BeiGene, marking a pivotal moment in the company's financial performance and the broader pharmaceutical industry in China [2][3]. Group 1: Market Performance - On September 2, BeiGene's A-share stock surged by 9.84%, reaching a total market capitalization of 507.4 billion yuan, making it the highest-valued pharmaceutical stock in A-shares [2]. - This marks the first time BeiGene's A-share market value has surpassed 500 billion yuan, joining other pharmaceutical companies like Hengrui Medicine that previously achieved this milestone [3]. Group 2: Financial Results - Since 2025, BeiGene's A-share stock price has doubled, indicating strong market confidence [4]. - In the first half of 2025, BeiGene reported revenue of 17.518 billion yuan, a year-on-year increase of 46%, and a net profit of 450 million yuan, marking a turnaround from losses [4]. Group 3: Product Performance - The company's profitability is attributed to the sales of its self-developed products, such as Baiyueze (Zebutinib) and Baizean (Tislelizumab), as well as the growth in sales from Amgen's licensed products [5]. - Baiyueze is noted as the most widely approved BTK inhibitor globally, generating 12.527 billion yuan in revenue, accounting for 72% of the company's total revenue [5]. Group 4: Future Prospects - BeiGene is focusing on enhancing its competitive edge in the hematological oncology field, with two late-stage products, Sotorasib (BCL2 inhibitor) and a first-in-class BTK CDAC, under development [6]. - The company plans to submit a marketing application for Sotorasib in China and other global markets by the second half of 2025, and to initiate a Phase III head-to-head trial for BTK CDAC [6]. - BeiGene aims to establish a sustainable product portfolio in the global chronic lymphocytic leukemia market, projected to reach 12 billion USD, leveraging the synergies among Baiyueze, Sotorasib, and BTK CDAC [6].

Core Viewpoint - 百济神州's A-share market value has surpassed 500 billion yuan for the first time, marking a significant milestone in the pharmaceutical sector [1][2]. Company Performance - On September 2, 百济神州's stock price surged by 9.84%, leading to a total market value of 507.4 billion yuan, making it the highest-valued pharmaceutical stock in A-shares [2]. - In the first half of 2025, 百济神州 achieved a revenue of 17.518 billion yuan, a year-on-year increase of 46%, and a net profit of 450 million yuan, marking its first profit driven by product sales rather than external licensing [4]. - The primary revenue driver was 百悦泽 (Zebutinib), which generated 12.527 billion yuan, accounting for 72% of the company's total revenue [4]. Product Development and Market Position - 百济神州 is recognized for its significant investment in R&D, earning the nickname "burning money king," but has begun to generate profits from product sales [4]. - The company is focusing on enhancing its competitive edge in the hematological oncology field, with two late-stage products: 索托克拉 (BCL2 inhibitor) and the first-in-class BTK CDAC [4][5]. - 索托克拉 has received acceptance for its listing application in China and is expected to submit applications to global regulatory bodies in the second half of 2025 [5]. Market Outlook - 百济神州 aims to establish a sustainable product portfolio in the global chronic lymphocytic leukemia market, projected to reach 12 billion USD, leveraging its differentiated products [5].

Group 1 - The core viewpoint of the article highlights that BeiGene's A-share market value has surpassed 500 billion yuan for the first time, reaching 507.4 billion yuan, making it the highest-valued pharmaceutical stock in A-shares [1] - The pharmaceutical sector has seen a revaluation since the first half of 2025, following a period of adjustment after a cooling market in the second half of 2021 [1][3] - BeiGene's stock price has doubled since the beginning of 2025, with the company achieving a revenue of 17.518 billion yuan in the first half of 2025, a year-on-year increase of 46% [1][3] Group 2 - The company's profitability is primarily driven by its self-developed products, such as Baiyueze (Zebutinib) and Baizean (Tislelizumab), along with sales growth from Amgen's licensed products [3][4] - Baiyueze is the highest revenue-generating product for BeiGene, with sales reaching 12.527 billion yuan, accounting for 72% of the company's total revenue [3] - Concerns have been raised regarding BeiGene's heavy reliance on Baiyueze and its ability to maintain high growth in a competitive BTK market [3] Group 3 - BeiGene is enhancing its competitive advantage in the hematological oncology field with two late-stage products: Sotorasib (BCL2 inhibitor) and a first-in-class BTK CDAC [4] - Sotorasib has received acceptance for its listing application in China for treating relapsed/refractory chronic lymphocytic leukemia and relapsed/refractory mantle cell lymphoma, with plans to submit applications in the US and other global markets in the second half of 2025 [4] - The company aims to establish a sustainable product portfolio in the $12 billion global chronic lymphocytic leukemia market through the synergistic promotion of Baiyueze, Sotorasib, and BTK CDAC [4]

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, assessing safety, tolerability, and efficacy of Sotorasib at doses of 160 mg and 320 mg [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] - BeiGene is submitting data to the FDA and other global regulatory agencies for potential approval of Sotorasib in MCL, with the drug already accepted for priority review by China's NMPA [2] Industry Context - The study's results mark a significant milestone in BeiGene's product portfolio for hematologic malignancies, which currently includes three major products aimed at addressing the evolving clinical needs of B-cell malignancy patients [2] - The ongoing Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302) has already enrolled its first patient earlier this year, further supporting the development of Sotorasib [2]

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its investigational BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Group 1: Clinical Trial Details - The BGB-11417-201 study is a global, multicenter, single-arm, open-label Phase 1/2 trial that enrolled 125 adult MCL patients previously treated with BTK inhibitors and anti-CD20 therapies [1] - In the first part of the study, 22 patients received daily doses of either 160 mg or 320 mg of Sotorasib to assess safety and tolerability, leading to the determination of the recommended dose for the second part [1] - The second part involved 103 patients receiving the recommended daily dose of 320 mg to evaluate the efficacy and safety of Sotorasib [1] Group 2: Efficacy and Safety Results - The study achieved the primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), indicating clinically meaningful responses in the patient population [2] - Secondary efficacy endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS), also showed positive results [2] - The safety profile of Sotorasib was generally well-tolerated, with manageable toxicity, marking an important milestone in BeiGene's product portfolio for hematologic malignancies [2] Group 3: Regulatory and Market Implications - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in the MCL indication [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study, CELESTIAL-RRMCL (BGB-11417-302), is ongoing, with the first patient enrolled earlier this year [2]

Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapy [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, with 22 patients in the first part receiving daily doses of 160 mg or 320 mg of Sotorasib to assess safety and tolerability [1] - In the second part, 103 patients received the recommended daily dose of 320 mg to evaluate efficacy and safety [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] Regulatory Progress - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in MCL indications [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study (BGB-11417-302) is ongoing, with the first patient enrolled earlier this year [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 自願性公告－業務發展最新情況 百濟神州宣佈索托克拉用於治療套細胞淋巴瘤(MCL)患者 的臨床研究取得積極結果 百濟神州有限公司（「百濟神州」或「本公司」）於2025年8月29日宣佈新一代且具有 同類最優潛力的在研BCL2抑制劑索托克拉用於治療既往接受過布魯頓氏酪氨酸激 酶(BTK)抑制劑和抗CD20治療的套細胞淋巴瘤(MCL)成人患者的1/2期臨床研究 (BGB-11417-201)取得積極結果，並計劃在即將召開的學術大會上公佈全部數據。 「對於MCL患者來說，疾病依然具有侵襲性，且治療選擇有限，療效也不盡如人 意。索托克拉的臨床研究結果表明其有潛力為MCL患者帶來顯著且持久的緩解。 若獲得批准，將為這部分患者提供首個BCL2抑制劑的治療選擇。」百濟神州全球 研發負責人汪來博士表示，「在過 ...

Group 1 - The complexity of hematological tumors presents numerous investment opportunities in various subtypes of treatment [1] - The market for hematological tumors is expanding due to innovative therapies, with significant product launches expected [1] - The number of long-term patients is increasing, with approximately 4 million patients globally having survived five years or more as of 2022, which is three times the number of new patients [1] Group 2 - Future development directions for hematological tumor treatment include improving efficacy, reducing recurrence, and optimizing administration [2] - Acute leukemias like AML and ALL primarily use chemotherapy or targeted combination therapies to enhance survival rates [2] - CAR-T therapy shows high remission rates for aggressive lymphomas and multiple myeloma, providing more treatment options for patients [2] Group 3 - The competition in the targeted drug market for hematological tumors has entered a new phase, with a focus on technological iterations and exploration of new targets [3] - In the BTK field, new products are emerging to compete in the post-resistance market, with Zebutinib outperforming Ibrutinib [3] - The BCL-2 domain is seeing advancements with differentiated designs and optimized dosing strategies to gain competitive advantages [3]