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Alphamab Oncology Reports Full Year 2022 Financial Results and Business Highlights

April 04, 2023 10:33 Eastern Daylight Time

Suzhou, China, April 3, 2023- Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2022 and highlighted recent progress and upcoming milestones.

 

Highlights

● Envafolimab excels in the innovative drug market: With significant clinical advantages, KN035 (Envafolimab) has been rated as one of the "Top Ten New Drugs in 2022" by People's Daily and has been included in six diagnosis and treatment guidelines by the China Clinical Oncology Society (CSCO). So far, it has benefited over 20,000 patients in China.

● KN046 enters the Pre-BLA phase: The Phase III clinical study of KN046 for the first-line treatment of advanced squamous non-small cell lung cancer achieved the preset endpoint of PFS, and the Phase III clinical study for the first-line treatment of advanced pancreatic cancer completed planned enrollment. We plan to submit two BLAs for KN046 in the treatment of sqNSCLC and PDAC in China in 2023.

● KN026 demonstrates excellent clinical results: KN026 has a progression-free survival of more than two years in first-line HER2-positive breast cancer. Phase III clinical trials for second-line gastric cancer are progressing smoothly, and Phase III clinical trials for first-line breast cancer are being pursued.

● New drug pipelines continue to expand: JSKN003, a bispecific ADC based on KN026, has started clinical trials in China and Australia, showing better serum stability, stronger bystander killing effects, and comparable tumor-killing activity. KN052, the world's first PD-L1/OX40 bispecific antibody in Phase I, has a unique drug mechanism, making it a potential candidate for combination with mRNA vaccines and cell therapies.

● Strengthening the foundation for sustainable innovation: We have developed an internationally leading, multi-dimensional industrialization development platform, including the preparation workshop and R&D center, while continually optimizing our strong R&D team.

● Impressive financial data: Operating revenue increased by 14.3% year-over-year, with product revenue increasing by 11.7 times. Operating loss decreased by 21%.

 

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, “Amid profound changes in the global biomedical field, Alphamab Oncology achieved fruitful results in 2022 through continuous development and innovation. The excellent performance of KN035 (Envafolimab), our first innovative drug to market, demonstrates our ability to address unmet medical needs through differentiated innovation. KN046 is poised to achieve a significant breakthrough in first-line treatment for advanced non-small cell lung cancer and pancreatic cancer this year, potentially establishing a new standard in these fields. Meanwhile, KN026 demonstrates great potential in breast and gastric cancer due to its excellent efficacy. JSKN003, a world-leading ADC based on bispecific antibodies and innovative glycoconjugation technology, and KN052, a uniquely designed immune checkpoint inhibitor and agonist in a series, represent our exploration of new approaches to tumor therapy. These two new programs initiated Phase I studies in 2022.

 

We are proud of our progress in R&D, manufacturing, and clinical development in 2022. Looking ahead to 2023, we will continue to adhere to the goal of ‘developing differentiated, clinically valuable, and internationally competitive new drugs’and seize the opportunity of commercialization of KN046 to establish an efficient commercial system and accelerate the delivery of innovative products to more patients.”

 

Business Highlights

Product Pipeline

We have established a globally competitive and differentiated pipeline comprising tumor monoclonal antibodies/single domain antibodies, multifunctional antibodies, and antibody-drug conjugates. Among these, the world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has received market approval from the Chinese National Medical Products Administration. Additionally, over 30 clinical studies have been conducted on six varieties worldwide.

 

KN046

KN046 is a bispecific antibody (BsAb) immune checkpoint inhibitor that simultaneously targets two clinically validated immune checkpoints, PD-L1 and CTLA-4, representing a potential breakthrough next-generation immuno-oncology blockbuster drug. Currently, around 20 clinical trials of KN046 are underway in various stages, covering over ten types of tumors, including NSCLC, TNBC, ESCC, HCC, PDAC, and thymic carcinoma in China, the United States, and Australia. The results of these clinical trials have demonstrated a preliminary profile of good safety and promising efficacy for KN046.

 

Events during the Reporting Period

● In February 2022, the first patient was successfully dosed in a multicenter, randomized, double-blind, and placebo-controlled phase III clinical trial of KN046 to evaluate its efficacy and safety in combination with nab-paclitaxel/gemcitabine versus placebo, for the treatment of locally advanced unresectable or metastatic PDAC without prior systemic treatment.

 

● In February 2022, the company received IND approval for KN046 from the NMPA to initiate a phase II clinical trial evaluating the efficacy, safety, and tolerability of KN046 combined with Inlyta® (axitinib) in treating advanced NSCLC.

 

● In February 2022, the company received IND approval for KN046 from the NMPA to initiate a phase I/II clinical trial of KN046 combined with MAX-40279, a multi-target tyrosine kinase inhibitor, for the treatment of advanced or metastatic solid tumors.

 

● In March 2022, we completed the first interim analysis of a phase III clinical trial of KN046 combined with platinum-based chemotherapy to evaluate its efficacy and safety in treating advanced unresectable or metastatic sq NSCLC. The trial reached the prespecified progression-free survival endpoint and demonstrated promising efficacy for KN046.

 

● We achieved positive efficacy and acceptable safety results in a phase II clinical trial of KN046 monotherapy as a second-line or higher treatment for unresectable locally advanced or metastatic PDAC. These research results were presented at the 2022 ASCO Annual Meeting in June 2022.

 

● We obtained further updates on the efficacy and safety results in an open-label, single-arm, multicenter phase II clinical trial of KN046 combined with Lenvatinib, a kinase inhibitor used to treat certain types of cancer, in patients with unresectable or metastatic HCC. These research results were presented at the 2022 ASCO Annual Meeting in June 2022.

 

● A phase III pivotal clinical trial design of KN046 combined with nab-paclitaxel/gemcitabine for treating advanced pancreatic cancer was presented at the 2022 ASCO Annual Meeting in June 2022.

 

● A phase II study design of KN046 in patients with thymic carcinoma who failed immune checkpoint inhibitors was presented at the 2022 ASCO Annual Meeting in June 2022.

 

● As of June 29, 2022, 110 patients were successfully dosed in a phase III clinical trial of KN046 combined with nab-paclitaxel and gemcitabine as first-line treatment for patients with unresectable locally advanced or metastatic PDAC.

 

● We made progress in obtaining good tolerability, promising clinical benefits as first-line treatment for NSCLC, and encouraging efficacy results in a phase II clinical trial of KN046 combined with platinum-based doublet chemotherapy in patients with NSCLC. These results were presented at the ESMO Congress 2022 in September 2022.

 

● We achieved good tolerability and efficacy results in a phase II clinical trial of KN046 in the treatment of advanced NSCLC patients who had failed first-line platinum-based doublet chemotherapy and showed promising overall survival benefits in both squamous and non-squamous NSCLC. These results were presented at the ESMO Congress 2022 in September 2022.

 

● We achieved good tolerability and efficacy results in a phase II clinical trial of KN046 in the treatment of patients with advanced NSCLC with EGFR sensitivity mutation who had failed prior EGFR-TKIs. These results were presented at the ESMO Congress 2022 in September 2022.

 

● We made progress in a phase II clinical trial of KN046, which demonstrated that the combination therapy of KN046 plus nab-paclitaxel showed favorable clinical efficacy in metastatic TNBC, especially in PD-L1 positive patients, and that patients in this trial tolerated the combination therapy well, with a manageable safety profile. These results were presented at the SABCS 2022 in December 2022.

 

Expected Milestones in 2023

 

● KN046+chemo, first-line squamous NSCLC: Submit BLA to CDE.

 

● KN046+chemo, first-line pancreatic cancer: Submit BLA to CDE.

 

● KN046+ Axitinib, first-line NSCLC: Complete enrollment in phase II clinical trial and data readout.

 

● KN046+ Axitinib, NSCLC (treated with PD-(L)1): Initiate phase II clinical trial in PD-(L)1 treated patients.

 

● KN046+ Axitinib, first-line NSCLC, head-to-head comparative study with PD-1+chemo: Start the pivotal trial.

 

KN026

KN026 is a next-generation anti-HER2 bispecific antibody that can simultaneously bind two distinct clinically validated epitopes of HER2, resulting in potentially superior efficacy. Our phase I/II clinical trials of KN026 in China and the U.S. have demonstrated early efficacy signals and a favorable safety profile in the treatment of heavily pre-treated HER2-expressing cancers.

 

Events during the Reporting Period

● In January 2022, the company received IND approval from the NMPA for a randomized and multicenter phase II/III clinical trial of KN026, aimed at evaluating the efficacy and safety of KN026 combined with chemotherapy in patients with HER2-positive GC (including GEJ) who have failed first-line treatment.

 

● In January 2022, patient enrollment in the phase II clinical trial of KN026 combined with KN046 for the treatment of HER2-positive solid tumors was successfully completed.

 

● In February 2022, data from a phase I clinical study of KN026 for the treatment of HER2-positive metastatic breast cancer were published in Clinical Cancer Research, a journal published by the AACR.

 

● We achieved preliminary safety and efficacy results in a phase II clinical trial of KN026 in combination with KN046 for the treatment of locally advanced unresectable or metastatic HER2-positive solid cancer (other than breast cancer and GC). These results were presented at the 2022 AACR Annual Meeting from April 8, 2022, to April 13, 2022.

 

● In April 2022, the first patient was successfully dosed in a phase II/III pivotal clinical trial of KN026 combined with chemotherapy for the treatment of HER2-positive GC (including GEJ) in patients who had failed first-line treatment.

 

● In May 2022, the first patient was successfully dosed in a multi-center and open-label phase II clinical trial of KN026, which aims to evaluate the efficacy, safety, and tolerability of KN026 in combination with Ibrance® (palbociclib), developed by Pfizer, and fulvestrant, in the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer in patients who have experienced disease progression after treatment with Trastuzumab and Taxanes.

 

● We achieved good efficacy and manageable safety clinical results in a single-arm, open-label, multi-center phase II clinical trial of KN026 monotherapy in patients with previously treated advanced HER2-expressing GC/GEJ. These research results were presented at the 2022 ASCO Annual Meeting in June 2022.

 

● In August 2022, the application for a phase III clinical trial of KN026 in combination with KN046 without chemotherapy was accepted by the NMPA for the treatment of locally advanced unresectable or metastatic HER2-positive GC/GEJ, and its IND approval was granted by the NMPA in October 2022.

 

● We obtained outstanding efficacy and manageable safety results in an open-label and multi-center phase II clinical trial of KN026 combined with KN046 in the treatment of patients with HER2-positive GC/GEJ without prior systemic treatment. These results were presented at the ESMO Congress 2022 in September 2022.

 

● In November 2022, the research results of a phase II clinical trial of KN026 as the second-line treatment of advanced HER2-expressing GC/GEJ were published in the European Journal of Cancer, which demonstrated excellent efficacy and good safety results. For details, please refer to the press release on the company's website dated November 23, 2022.

 

● We made progress in a phase II clinical trial of KN026, which demonstrated that KN026 in combination with docetaxel is well tolerated and has shown promising clinical benefit as a first-line treatment for HER2-positive advanced breast cancer, encouraging efficacy results, and significant, long-term survival benefits. These results were presented at the SABCS 2022 in December 2022.

 

● We obtained promising clinical benefits and acceptable, manageable safety results in a phase II clinical trial of KN026 in combination with docetaxel as neoadjuvant treatment in patients with HER2-positive early or locally advanced breast cancer. These results were presented at the SABCS 2022 in December 2022.

 

Expected Milestone in 2023:

● KN026+ chemo, 1L HER2+ breast cancer: Start phase III clinical trials.

 

● KN026+ chemo, ≥2L HER2+ gastric cancer: Accelerate patient enrollment.

 

KN035

KN035, an innovative anti-tumor immunotherapy drug, is the first subcutaneously injectable PD-L1 inhibitor worldwide. It is also the only immunotherapy drug aimed at cross-tumor indications and the first domestically-produced PD-L1, offering advantages in effectiveness, safety, convenience, compliance, and lower medical costs. KN035 is currently undergoing a phase III pivotal trial for biliary tract cancer in China, and pivotal trials in undifferentiated pleomorphic sarcoma and malignant fibrous histiocytoma are ongoing in the United States.

 

Events during the Reporting Period

● From April 23 to 24, 2022, at the CSCO Guideline Conference, KN035 (Envafolimab) was acknowledged by the Chinese clinical oncology community and officially included in three 2022 CSCO guidelines: Gastric Cancer, Colorectal Cancer, and Clinical Application of Immune Checkpoint Inhibitors.

 

● In August 2022, KN035 (Envafolimab) was listed as one of the Top 10 New Drugs (Domestic) by the 14th Healthy China Annual Forum.

 

● In August 2022, a new dosage of KN035 (Envafolimab), "300mg once every two weeks", was approved by the NMPA.

 

● In September 2022, the FDA granted fast-track designation to KN035 (Envafolimab) for the treatment of locally advanced, unresectable, or metastatic pleomorphic sarcoma/fibrohistiocytic sarcoma, which were progressive after first-line/second-line chemotherapy.

 

● In October 2022, KN035 (Envafolimab) was further included in another three 2022 CSCO guidelines: Endometrial Cancer, Cervical Cancer, and Ovarian Cancer.

 

● Updated follow-up data of KN035 (Envafolimab) for the treatment of patients with advanced solid tumors with MSI-H/dMMR who have failed prior at least first-line treatment was presented at the 2022 CSCO Annual Meeting in November 2022, demonstrating persistent clinical benefits. For details, please refer to the press release on the Company's website dated November 18, 2022.

 

● In December 2022, the ENVASARC pivotal trial of KN035 (Envafolimab) in the U.S., conducted by TRACON Pharmaceuticals, Inc., reached positive results in its interim analysis on safety and efficacy. For details, please refer to the press release on the Company's website dated December 15, 2022.

 

Expected Milestone in 2023

● KN035, 1L soft tissue sarcomas: Complete enrollment for the pivotal clinical trial in the US.

 

JSKN003

JSKN003, a bispecific-antibody ADC based on KN026, is developed in-house with a proprietary Glycan-specific conjugation platform. JSKN003 demonstrates better serum stability, stronger bystander killing effect, and comparable tumor-killing activity, ensuring a much wider therapeutic window.

 

Events during the Reporting Period

● In September 2022, a phase I, multi-center, open-label, dose-escalation, and first-in-human study began in Australia to assess the safety, tolerability, and determine the maximum tolerated dose/recommended phase II dose (MTD/RP2D) of JSKN003 in subjects with advanced or metastatic malignant solid tumors. The first patient was successfully dosed.

 

● In October 2022, the Company received IND approval from the NMPA for initiating a phase Ia/IIb clinical trial of JSKN003. The trial is designed to evaluate the safety and tolerability of JSKN003 in Chinese patients with advanced malignant solid tumors and to determine MTD and/or recommended RP2D of JSKN003 in the treatment of advanced malignant solid tumors.

 

Events after the Reporting Period and Expected Milestone in 2023:

● In March 2023, the first patient was dosed with 2.1mg/kg in a Phase I clinical study of JSKN003.

 

● JSKN003: Begin two pivotal clinical trials.

 

KN052

KN052, an innovative PD-L1/OX40 bispecific antibody, was independently developed by the Group using its bispecific antibody platform. It can simultaneously bind PD-L1 and OX40, effectively reversing tumor-induced immune inhibition by blocking the PD-L1/PD-1 pathway and promoting the immune response by agonizing OX40.

 

Events during the Reporting Period

● In February 2022, the Company received IND approval for KN052 from the NMPA, allowing for the initiation of a phase I clinical trial.

 

● In June 2022, the Phase I clinical study of KN052 in advanced solid tumor patients in China completed the first patient administration. The study aimed to evaluate the safety, tolerability, PK/PD, and antineoplastic activity of KN052 and determine the recommended dosage for subsequent studies.

 

Events after the Reporting Period

● In February 2023, we entered into a strategic cooperation with Stemirna Therapeutics (Shanghai) Biotechnology Co., Ltd. to explore the combination therapy of KN052 and personalized mRNA tumor vaccine SWP1001.

 

● In March 2023, the preclinical research results of KN052 were accepted as Late Breaking Research to be presented as a poster at the 2023 annual meeting of AACR. The preclinical data of KN052 demonstrated an acceptable pharmacokinetic and safety profile.

 

KN019

KN019, a CTLA-4-based immunosuppressant fusion protein, has potential broad applications in both autoimmune diseases and oncology treatment-induced immune disorders.

● The phase II clinical trial of KN019 for the treatment of RA reached its primary endpoints in September 2022.

 

Manufacturing Facilities

Our workshop covers an area of 75 mu. The production line is equipped with world-class equipment that meets GMP regulations of NMPA, FDA, and EMA. The facility has a total production capacity of 42,000L, with an annual production capacity now exceeding 5 million. In 2022, the pharmaceutical preparation workshop, pilot workshop, and R&D center were put into use, and three new 2000L scale production lines were completed.

 

Other Highlights

● In January 2022, the Company received "The Most Valuable Pharmaceutical and Medical Company" award at the Sixth Golden Hong Kong Stocks Awards ceremony.

 

● In September 2022, the Company was listed among the 2022 Top 100 Chinese Pharmaceutical Innovative Enterprises, marking the fourth consecutive year of this recognition. Additionally, the Company ranked in the top echelon among the 2022 Top 100 Chinese Pharmaceutical Innovative Enterprises.

 

● In October 2022, the Company was identified as a "national high-tech enterprise."

 

● In December 2022, the Company received "The Most Valuable Pharmaceutical and Medical Company" award at the Seventh Golden Hong Kong Stocks Awards ceremony for the third consecutive year.

 

Financial Summary

● For the year ended December 31, 2022, we recorded a total revenue of RMB 166.85 million, a 14.3% year-over-year increase. Meanwhile, product revenue reached RMB 147.54 million, an 11.7 times year-over-year increase.

 

● For the year ended December 31, 2022, we recorded a total loss of RMB 325.72 million, a 21.0% year-over-year decrease.

 

● For the year ended December 31, 2022, our R&D expenditure amounted to RMB 468.24 million, remaining relatively stable compared to 2021.

 

For more information, please refer to the company's 2022 annual results announcement published on the Hong Kong Stock Exchange and the company's official website.

 

About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company dedicated to the discovery, development, manufacturing, and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of the Hong Kong Stock Exchange, with the stock code: 9966.

 

We have assembled a professional R&D team led by top scientists and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production, to clinical research.

 

With multiple in-house proprietary platforms for bispecifics, protein engineering, and antibody screening, Alphamab Oncology has established a globally competitive and differentiated pipeline consisting of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among them, two products were selected for the national special project of "New Drug Development," and three products were granted four orphan drug qualifications by the FDA. The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has received market approval from the Chinese National Medical Products Administration. More than 30 clinical studies have been conducted on six products in China, the United States, and Australia, with eight studies of three products entering the critical clinical stage in China and the United States.

 

To make cancer manageable and curable, Alphamab Oncology has always been guided by clinical value and patient needs, focusing on the development of innovative, safe, and affordable anti-tumor drugs to benefit patients in China and around the world.