On August 26, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the NDA for new indication of HANSIZHUANG, serplulimab, an anti-PD-1 mAb independently developed by the company, in combination with chemotherapy for the first-line treatment of patients with locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC) has been accepted by the National Medical Products Administration (NMPA) (Press release, Shanghai Henlius Biotech, AUG 26, 2022, View Source [SID1234622747]). HANSIZHUANG has been approved by NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumors, and the NDAs of first-line squamous non-small cell lung cancer (sqNSCLC) and first-line extensive-stage small cell lung cancer (ES-SCLC) indications have been accepted. ESCC is the fourth indication for HANSIZHUANG has been accepted by NMPA.

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Professor Jing Huang, the principal investigator of ASTRUM-007 from Cancer Hospital Chinese Academy of Medical Sciences, said, "ASTRUM-007 is a phase 3 clinical study enrolled locally advanced/recurrent or metastatic ESCC patients with PD-L1 CPS≥1 of serplulimab. In the planned interim analysis evaluated by the Independent Data Monitoring Committee (IDMC), the study has met the co-primary endpoints, providing evidence of safety and efficacy. PD-1 inhibitors combined with chemotherapy has become the first-line standard treatment for advanced esophageal cancer in China. We are hoping that the approval of HANSIZHUANG for the treatment of ESCC comes soon and bring a new treatment option to patients living with ESCC. "

Mr. Jason Zhu, President of Henlius, said, "HANSIZHUANG is an innovative mAb independently developed by Henlius, and ESCC is the fourth indication for which the company filed application. Based on the large number of unmet clinical needs as well as the intractable cancers both globally and in China, we developed differentiation strategy around serplulimab to promote the combination immunotherapy of HANSIZHUANG and clinical research, thereby benefiting more patients in China and around the world."

Esophageal cancer is high incidence in China. According to estimates of the prevalence of malignant tumours in China in 2016, there were 253,000 new cases and 194,000 deaths of esophageal cancer, ranking sixth and fifth in malignant tumors in China, respectively[2]. Since the symptoms of early esophageal cancer are often subtle, most patients are diagnosed in the middle or late stages, missing out on surgical treatment. The mainly treatment for advanced patients is systematic treatment (chemotherapy or targeted therapy), but the treatment result is often limited with the highly recurrence and metastasis rate. Therefore, new drugs and treatments are urgently needed. In recent years, immuno-oncology therapy has become one of the research priorities at home and abroad. Many studies have shown that anti-PD-1 mAb combined with chemotherapy can bring survival benefits to patients with esophageal cancer. Immune checkpoint inhibitor combined with chemotherapy has become the first-line standard treatment for esophageal cancer in China[3].

The NDA is mainly based on the results from a randomized, double-blind, multicenter phase 3 clinical study (ASTRUM-007) comparing HANSIZHUANG in combination with chemotherapy (Cisplatin + 5-FU) or placebo in combination with chemotherapy (Cisplatin + 5-FU) as a first-line treatment for patients with locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. In May 2022, the results of interim analysis conducted by IDMC stated that HANSIZHUANG in combination with chemotherapy showed a significant improvement in PFS and OS against placebo in combination with chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of new safety signal.

Underpinned by the patient-centric strategy, serplulimab clinical layout covered high incidence tumours

HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. It has been approved by the NMPA for the treatment of microsatellite instability-high (MSI-H) solid tumours. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications, such as lung cancer, hepatocellular carcinoma, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. Up to date, more than 3,100 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.

In the field of gastrointestinal cancer, HANSIZHUANG has been approved for the treatment of MSI-H solid tumours, which could benefit for patients with MSI-H colorectal cancer and MSI-H gastric cancer. In addition, PD-1 inhibitors are less explored in neoadjuvant/adjuvant therapies for gastric cancer, and Henlius has led the way with a Phase 3 clinical study, striving to benefit gastric cancer patients from the early line of immunotherapy. As for the first-line lung cancer treatment, HANSIZHUANG would potentially be the world’s first PD-1 inhibitor for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of SCLC for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC.

Going forward, Henlius will continue conducting clinical studies for more innovative products, proactively exploring immuno-oncology combination therapy, bispecific antibodies and the antibody-drug conjugates (ADC), committing to bringing affordable and high-quality innovative biologics to patients around the world.

About Serplulimab

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 3 NDAs have been accepted by the NMPA, and 11 clinical trials are ongoing across the world.

HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors in March 2022 and actively promotes its synergy with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive small-cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC.

On August 26, 2022 Shanghai Bao Pharmaceuticals reported that it closed a Series B round with over $100 million to support development of its recombinant protein and antibody drug candidates, including commercialization (Press release, Shanghai Bao Pharmaceutical, AUG 26, 2022, View Source [SID1234618714]). Bao Pharma will also advance its pre-clinical projects into clinical trials. The company is building a 75,000 square meter facility in Laodian Industrial Park, located in Shanghai’s Baoshin District, which will house its R&D operations and manufacturing facilities for recombinant protein drugs and injected drugs. The round was led by Oriental Fortune Capital and included Haitong Innovation and Sun Rock Capital.

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On August 26, 2022 Fosun International Limited ("Fosun International", stock code: 00656.HK) and HSBC Bank (China) Company Limited ("HSBC China") renewed a strategic cooperation agreement (the "Agreement") reported to provide strong support for Fosun International and its subsidiaries ("Fosun") in the aspects of global operation and investment capabilities, growth strategies, financial resources, etc (Press release, Fosun, AUG 26, 2022, View Source [SID1234618712]).

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In the presence of Wang Qunbin, Co-Chairman of Fosun International, and Wang Yunfeng, President and Chief Executive Officer of HSBC China, Zhang Houlin, Senior Vice President and Co-CFO of Fosun International, and Ma Jian, Executive Vice President, Country Head of Commercial Banking of HSBC China signed a strategic cooperation agreement today at Fosun’s Bund Finance Center in Shanghai, marking further cooperation between Fosun and HSBC. The two parties will work together to support the strategic goal of stabilizing economic growth, promote the high-quality development of private enterprises, and make new and greater contributions to advance both the pandemic prevention and economic and social development.

Wang Qunbin, Co-Chairman of Fosun International, said, "As a global innovation-driven consumer group, after 30 years of development, Fosun has grown into one of the few domestic enterprises that is equipped with global operation and investment capabilities, and accumulated profound technology and innovation capabilities. Fosun has a diversified business portfolio, globalized asset allocation, and has always maintained good relationship with financial institutions, resulted in its stable business operations and abundant capital. While continuing to develop the four business segments of Health, Happiness, Wealth, and Intelligent Manufacturing, Fosun remains true to its original aspiration and actively fulfills its corporate responsibility. Since the COVID-19 outbreak, Fosun has contributed to the prevention of the pandemic and promoted the resumption of work and production in an orderly manner. HSBC has always been an important long-term strategic partner of Fosun. In the future, Fosun will continue to work with HSBC to continuously deepen our globalization strategy, strengthen our investment and development in continuous innovation, actively fulfill corporate social responsibility to make greater contributions to national economic and social development."

Wang Yunfeng, President and Chief Executive Officer of HSBC China, said, "As a leading private enterprise in China, Fosun has been actively innovating in many fields and promoting globalization over the years, and has played an important role in the prevention of the COVID-19 pandemic and the resumption of work and production. Leveraging our global network advantage and local service capability, HSBC is committed to providing financial support to private enterprises with global vision like Fosun, and contributing to the growth and transformation of China’s economy. Through this renewal of the strategic cooperation agreement, HSBC will further strengthen its cooperation with Fosun to promote the win-win situation of both parties in more fields, providing support for the sustainable and high-quality development of private enterprises. "

HSBC is an internationally renowned financial institution. Through this Agreement, Fosun International and HSBC China are committed to strengthening the cooperation between the two parties. On the basis of strategic fit, complementary advantages, and mutual support, the two parties will carry out comprehensive cooperation in the future.

On August 26, 2022 Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company committed to the research, development, manufacturing and commercialization of either first-in-class or best-in-class therapies, reported a review article featuring on Cadonilimab, a first-in-class PD-1/CTLA-4 bi-specific antibody developed by the company, was published in Drugs, a peer-reviewed medical journal specializing in pharmaceutics (Press release, Akeso Biopharma, AUG 26, 2022, View Source [SID1234618711]).

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Article link: View Source

The article provides an in-depth and comprehensive summary of the prospective drug design rationale of Cadonilimab, clinical trials progress in different tumors, and milestones in the development of Cadonilimab leading to its first approval.

Cadonilimab received its first approval on June 2022 in China for use in patients withrelapsed or metastatic cervical cancer (r/m CC) who have progressed on or after platinum-based chemotherapy. Cadonilimab is the globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing. It is worth mentioning that the approval of Cadonilimab not only marks China’s innovative biotech companies starting to reap the fruits after years of R&D investments but also demonstrates that Chinese biotech companies represented by Akeso are closing the gap with global pharmaceutical companies rapidly in innovative drug development.

There are many ongoing trials of Cadonilimab as monotherapy or combination therapy for the treatment of a range of solid tumors, including cervical cancer, lung cancer, gastric/gastroesophageal junction cancer, oesophageal squamous cell cancer, liver cancer, and nasopharyngeal cancer.

In addition to Cadonilimab, Akeso also promotes many drug candidates efficiently. Ivonescimab (PD-1/VEGF bi-specific antibody, AK112), the second globally first-in-class bi-specific antibody, is in phase III trials, and the third bi-specific antibody(PD-1/LAG-3) is about to enter the clinical stage. Akeso hopes to bring more innovative high-quality biologics to the market for the benefit of patients worldwide.

For 50 years, Drugs has been the definitive journal of drugs and therapeutics, promoting optimum pharmacotherapy by publishing reviews and original research authored by leading international clinicians and researchers to support clinical decision-making. In 2022, Drugs has an impact factor of 11.431.

On August 26, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported its 2022 interim results (Press release, Ascentage Pharma, AUG 26, 2022, View Source [SID1234618710]). During the reporting period, Ascentage Pharma remained steadfastly committed to its strategy of global innovation and made remarkable progress in clinical development and commercialization. Highlighting these results, Ascentage Pharma reported the first half-year sales and the accelerating commercialization of its first approved product, olverembatinib.

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During the reporting period, Ascentage Pharma achieved steady improvement to its cash flow. As of June 30, 2022, the company’s cash and bank balances were RMB1,698 million, which remained relatively constant when compared with the cash and bank balances as of December 31, 2021. Meanwhile, the company’s revenue for the six months ended June 30, 2022 substantially increased by 636.9%, from the same period last year, to RMB95.76 million. This increase in revenue was mainly attributable to the sales of olverembatinib, commercialization license fee income of patented IP and service income from customers. It is worth noting that since its approval in last November till the end of June 2022, olverembatinib has already realized an accumulated invoiced sales revenue amount of RMB95.93 million (unaudited, inclusive of value added tax).

Accelerated the commercialization of olverembatinib while continued to explore the drug’s therapeutic potential

Olverembatinib, the first and only drug approved for the treatment of chronic myeloid leukemia (CML) harboring the T315I mutation in China and Ascentage Pharma’s core asset that was designated a National Major New Drug Development and Manufacturing Program, effectively ended of the lack of treatment options for patients with CML harboring the T315I mutation, therefore has enormous clinical value. Since being approved till the end of June 2022, olverembatinib has realized an accumulated invoiced sales revenue amount of RMB95.93 million (unaudited, inclusive of value added tax).

To date, Ascentage Pharma has built a commercial organization possessing a wealth of experience in hematology and entered into a strategic collaboration with Innovent Biologics to jointly commercialize olverembatinib in China. In the months since its approval till June 2022, olverembatinib has been included by 34 government-backed local supplementary insurance programs in 10 provinces, substantially expanding the drug’s accessibility to patients. Meanwhile, olverembatinib was included into the Chinese Society of Clinical Oncology (CSCO) Guidelines and the China Anti-Cancer Association’s (CACA) 2022 Guidelines for the Holistic Integrative Management of Cancers, thus provided clinicians the necessary guidance in their practices. As a China-developed novel drug with clear global best-in-class potentials, olverembatinib is bringing clinical benefits to a growing number of patients around the world.

In partnership with Tanner Pharma, a global pharmaceutical services provider of specialty access solutions, Ascentage Pharma launched an innovative Named Patient Program (NPP) similar to the early access programs seen in the city of Boao in Hainan province, to allow Tanner to supply olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available. The NPP plans to cover more than 130 countries and regions around the world.

In July 2022, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) accepted and granted Priority Review designation to a New Drug Application (NDA) that will support the full approval of olverembatinib in patients with chronic-phase chronic myeloid leukemia (CML-CP) who are resistant and/or intolerant of first- and second-generation tyrosine kinase inhibitors (TKIs). Following the conditional approval for olverembatinib in 2021, this marks another milestone development that would expedite olverembatinib’s journey to a broader population of patients with CML in China.

Currently, Ascentage Pharma is actively advancing the clinical development of olverembatinib globally. During the reporting period, olverembatinib was cleared by Health Canada to enter a Phase Ib study in patients with refractory CML or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), making it Ascentage Pharma’s first clinical study in Canada. Prior to this, olverembatinib had already been cleared to enter clinical trials in the US.

In addition to hematologic indications, the company is also exploring olverembatinib’s clinical utility in other therapeutic areas. At the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma released the first dataset of olverembatinib in patients with gastrointestinal stromal tumor (GIST). These results showed promising antitumor activity in patients with TKI-resistant succinate dehydrogenase- (SDH-) deficient GIST with a clinical benefit rate (CBR) of 83.3%.

Furthermore, a new preclinical study discovered olverembatinib’s therapeutic potential as an alternative treatment for patients with moderate to severe COVID-19 infections. These preclinical data have already been published by the EMBO Molecular Medicine, a renowned scientific journal affiliated to the European Molecular Biology Organization (EMBO).

These studies demonstrated olverembatinib’s therapeutic potential and differentiated clinical utility in a wide range of therapeutic areas. With expected further expansion of its indications, olverembatinib will benefit a broad patient population globally.

Executing the strategy of global innovation as a pioneer for the industry

In the first half of 2022, Ascentage Pharma continued to increase its investment in innovation, with the research and development expenses increased by 7.5% year on year, to RMB341 million. Pressing ahead with its global clinical development programs, nine of Ascentage Pharma’s candidate drugs have already entered the clinical stage, currently being evaluated in more than 50 Phase I/II clinical studies in China, the US, and Australia. Meanwhile, Ascentage Pharma has further strengthened its intellectual property portfolio, paving the way for its accelerating research and development. As of June 30, 2022, the company holds 205 issued patents and more than 600 patent applications globally, among of which, 148 patents were issued overseas.

During the reporting period, Ascentage Pharma made rapid progress with its momentous clinical development programs covering an array of therapeutic areas. In addition to the company’s apoptosis-targeting assets and kinase inhibitors, Ascentage Pharma has also made strides with the development of candidate drugs targeting other novel targets, including its embryonic ectoderm development (EED) protein inhibitor that has attracted widespread interest from the research community. The EED inhibitor, APG-5918, was cleared by the US Food and Drug Administration (FDA) to enter a first-in-human study evaluating the safety, pharmacokinetics, and efficacy of APG-5918 in patients with advanced solid tumors and hematologic malignancies, and the IND for APG-5918 has already been accepted by the CDE in China. As the first China-developed EED inhibitor entering clinical development, APG-5918 underlines Ascentage Pharma’s capabilities in discovering and developing first-in-class/best-in-class novel assets.

While making strides with its global innovation, Ascentage Pharma was granted two Fast-Track designations and two Rare Pediatric Disease designations by the US FDA, and a total of 16 Orphan Drug designations by the US FDA and the EMA of the EU, a record number for any Chinese biopharmaceutical company.

Multiple highly differentiated clinical programs are steadily approaching fruition

As a global leader in the development of apoptosis-targeted drugs, Ascentage Pharma has presented the clinical data of its investigational assets at multiple international scientific congresses showcasing the first-in-class and best-in-class potential of these assets.

A Phase II pivotal study of lisaftoclax (APG-2575), the first China-developed Bcl-2 selective inhibitor entering clinical development and a key member of the company’s apoptosis-targeted pipeline, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) was approved by the CDE at the end of 2021 and dosed its first patients in March 2022, making lisaftoclax the second Bcl-2 selective inhibitor entering pivotal trials globally. To date, lisaftoclax is being investigated in a total of 19 studies globally for the treatment of multiple hematologic malignancies and solid tumors, and has shown promising therapeutic potentials.

During the reporting period, Ascentage Pharma announced the updated data of lisaftoclax in Chinese patients with R/R CLL/SLL at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. These data showed an objective response rate (ORR) of 67.4% and favorable tolerability. In terms of safety, most adverse events were manageable, no dose-limiting toxicity (DLT) was observed at the maximum dose of 800mg, and the risk of clinical tumor lysis syndrome (TLS) in patients on daily dose ramp-up was minimal.

Furthermore, Phase I data of lisaftoclax in Chinese patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL) were released at the 2022 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress. These data showed, lisaftoclax was well tolerated at doses of up to 800 mg/day, without evidence of TLS, and has antitumor activity in a range of relapsed/refractory hematologic malignancies such as CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and T-cell NHL. In the 11 efficacy evaluable patients with CLL (all of whom were heavily pretreated and had failed prior therapies such as chemoimmunotherapies and Bruton’s tyrosine kinase [BTK] inhibitors, and the majority had at least one type of adverse prognostic factors such as 17p deletion/TP53 mutation), there were 8 efficacy evaluable patients in cohorts received 200 mg or higher doses, including 3 complete responses (CRs) and 4 partial responses (PRs), thus demonstrating an ORR of 87.5%. There is a growing body of evidence signifying the global best-in-class potential of lisaftoclax.

While at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma reported the updated clinical data of alrizomadlin (APG-115), a MDM2-p53 inhibitor that is also a key asset in the company’s apoptosis-targeted pipeline, in combination with pembrolizumab. These data validated the antitumor efficacy of the combination therapy in patients with immuno-oncologic- (I-O) drug-resistant or recurrent melanoma, including two CRs, an ORR of 11% and a disease control rate (DCR) of 57%. The study also observed promising clinical benefit to patients with malignant peripheral nerve sheath tumor (MPNST), demonstrated by a DCR of 50%. MPNST is a rare pediatric type of sarcoma lacking effective treatment options. These results provide additional evidence validating the synergy and the first-in-class potential of MDM2-p53 inhibitors plus immuno-oncologic drugs.

Also at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma released the first dataset from the Phase I study of the company’s novel FAK inhibitor and third-generation ALK/ROS1 TKI, APG-2449, in patients with second-generation TKI-resistant ALK/ROS1+ non-small-cell lung cancer (NSCLC) or mesothelioma. According to these results, 4 of the 14 ALK+ patients resistant to second-generation TKIs achieved PRs, 10 TKI-naïve patients achieved an ORR of 80%, at a DCR of 100%. APG-2449 is the first China-developed third-generation ALK inhibitor. The candidate drug’s clinical progress is a manifestation of Ascentage Pharma’s R&D capabilities in the field of solid tumors.

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said, "In the first half of 2022, Ascentage Pharma made solid progress in both commercialization and clinical development, successfully navigated the challenging circumstances posted by the COVID-19 pandemic. The rapid and successful commercialization of olverembatinib, the first and only third-generation BCR-ABL inhibitor, in the months after the NDA approval, has led to substantial revenue growth, allowing us to maintain a healthy cash flow that is essential to the company’s long-term development.

While forging ahead with the commercialization of olverembatinib in China, we launched a global NPP to offer patient access to olverembatinib in areas where the drug is not yet commercially available, in efforts to meet the unmet medical needs of patients from around the world. The NPP highlights olverembatinib’s differentiated clinical value and serves as a very important prelude to the drug’s future global launch. To our surprise, we discovered olverembatinib’s therapeutic potential as an alternative treatment for COVID-19 infections, and we plan to further evaluate the drug in clinical settings.

Executing on our strategy of global innovation, we presented the latest research data and clinical results of lead assets including olverembatinib, lisaftoclax, alrizomadlin, and APG-2449, at multiple international congresses such as the ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper), and AACR (Free AACR Whitepaper) annual meetings. These data readouts are indicative of our rich portfolio and promising clinical programs that are steadily approaching the point of fruition.

As a company focused on original pharmaceutical innovation, we will continue to expand the accessibility, advance the indication expansion and global clinical development of olverembatinib, while pressing ahead with the development programs of other investigational assets. We will remain steadfastly committed to global innovation and the mission of addressing unmet clinical needs in China and around the world, to create additional value for our investors and bring much needed novel therapies to our patients as soon as possible."