On March 29, 2022 Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2021 and highlighted recent progress and upcoming milestones (Press release, Alphamab, MAR 29, 2022, View Source [SID1234611143]).
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Highlights
First product launch: In November 2021, KN035 (Envafolimab) has received marketing authorization from the Chinese National Medical Products Administration (NMPA), becoming the world’s first and currently only subcutaneously injected PD-L1 antibody approved for marketing.
First year of commercialization: We recorded total revenue of RMB146.0 million yuan for the year ended December 31, 2021, of which RMB11.62 million yuan of revenue from the shipment of Envafolimab, RMB134 million yuan of revenue from KN026.
Rapid advancement of pivotal clinical trials: Several pivotal clinical studies of KN046 are ongoing, including squamous non-small cell lung cancer, PD-(L)1 refractory NSCLC, pancreatic cancer, thymic carcinoma, etc. BLA is expected to be submitted in 2022.
Exploring cornerstone therapies in the post-PD-(L)1 era: 10 clinical data of KN046 presented, continuing to explore major indications, PD-(L)1 refractory and PD-(L)1 inadequate response tumors; KN046 in combination with KN026 is expected to offer a chemotherapy-free solution.
Build a core commercialization team: In 2021, the company established a core commercialization team to accelerate the commercialization of KN046 and subsequent blockbuster products.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented, "2021 is the first year of the company’s commercialization. Envafolimab is the first domestic PD-L1 antibody approved for marketing in China and the world’s only subcutaneously administered PD-L1 antibody. KN046 has demonstrated excellent efficacy and potential for benefit in treating PD-(L)1 refractory and PD-(L)1 inadequate response tumors, etc. The BLA of KN046 insquamous NSCLC will be submitted soon. The pivotal phase III trials of KN046 in pancreatic cancer and PD-(L)1 refractory NSCLC have been initiated. A pivotal clinical trial of KN026, an anti-HER2 bispecific antibody, combined with chemotherapy as second-line treatment for gastric cancer has been initiated, and trials in the 1st-line and perioperative setting are under way. Data from the phase II study of KN026 combined with KN046 pave the way for further exploring chemotherapy-free regimens for HER2-positive solid tumors.
In 2021, the company has also made significant progress in our innovative R&D platform and product pipeline. We expect the innovative mechanism and preclinical efficacy of KN052 and JSKN-003 to be validated in clinical studies in 2022. Unmet medical needs, differentiation and global edge are the principles we have always adhered to.
The MRCT pivotal trial of KN046 in thymic carcinoma demonstrated our ability and confidence to develop innovative drugs to meet global health needs. Through cooperation with Pfizer, CSPC and other partners, we hope to accelerate the research and development of our candidates, and to benefit oncology patients worldwide as soon as possible.
Through the launch of Envafolimab, the company’s GMP has been fully validated. We will further expand our production capacity, improve our system, and expand our commercialization capability to lay a solid foundation for the launch of KN046 and subsequent new drugs. With 2021 already behind, we look forward a more exciting and rewarding 2022. Alphamab Oncology will stick to its vision and mission and develop steadily. We are working for more effective cancer medicines and will generate great returns for our long term shareholders.
BUSINESS HIGHLIGHTS
Since April 20, 2021, being the latest practicable date of the Company’s 2020 annual report, we have been making significant progress with respect to our product pipeline and business operations.
Product Pipeline
Our highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Our differentiated tumor product pipeline includes one approved for marketing by the NMPA, three in late clinical stage, and two that have received IND approval or ready for IND submission.
KN046
KN046 has completed phase I clinical trials in Australia and has simultaneously been under a phase II clinical trial in the U.S. Currently, four pivotal clinical trials of KN046 in China have been launched, including two pivotal clinical trials in NSCLC, one pivotal phase III clinical trial in PDAC and one pivotal trial in thymic carcinoma. There are approximately 20 clinical trials around the world covering more than 10 types of tumors including NSCLC, triple-negative breast cancer, ESCC and thymic carcinoma. The results of these clinical trials have demonstrated a preliminary profile of good safety and promising efficacy of KN046.
Events during the Reporting Period
In April 2021, we entered into a clinical trial collaboration and supply agreement with Pfizer Inc. to evaluate the efficacy and safety of KN046 in combination with Inlyta (axitinib), for the first-line treatment of NSCLC.
We achieved positive results of KN046 with respect to its preliminary efficacy and safety in combination with nab-paclitaxel and gemcitabine as first-line treatment for unresectable locally advanced or metastatic PDAC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We achieved promising preliminary results in a phase II, open-label and multi-center study of KN046 in combination with chemotherapy in patients with advanced NSCLC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the efficacy and safety results of KN046 plus paclitaxel/ cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic ESCC. Such research progress was presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
We made progress in obtaining the preliminary efficacy and safety results of a prospective phase II trial of KN046 in combination with Lenvatinib in the first-line treatment for advanced unresectable or metastatic HCC. Such research progress was presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We obtained research results of a phase II, open-label and multi-center clinical trial of KN046 in combination with platinum doublet chemotherapy as first-line treatment for advanced NSCLC harboring resistant oncogenic driver alterations. Such research results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
In September 2021, we received an IND approval for KN046 from the NMPA for initiating a multi-center, open-label and randomized-controlled phase II/ III pivotal clinical study (ENREACH-LUNG-02/KN046-302) to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted PD-(L)1 treatment.
We achieved significant efficacy and safety results of KN046 in combination with nab-paclitaxel/gemcitabine in the first-line treatment of locally advanced unresectable or metastatic PDAC. Such results were presented at the 2021 CSCO Annual Meeting.
In September 2021, the Company entered into a partnership agreement with Hangzhou Raygene Pharmaceutical Co., Ltd. to jointly develop the combination therapy of KN046 and RG001, a proprietary anti-tumor small molecule drug, for the posterior line treatment for advanced HCC and liver metastasis colorectal cancer.
In October 2021, a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous NSCLC, completed the enrollment of 482 patients.
In October 2021, the first patient was successfully dosed in a multi-center, open-label and randomized-controlled phase II/III pivotal clinical trial of KN046 in Mainland China, which aims to evaluate the efficacy, safety and tolerability of KN046 combined with Lenvatinib versus Docetaxel in disease progression of patients with advanced NSCLC who have accepted anti-PD-(L)1 treatment.
In November 2021, the first patient was successfully dosed in a clinical trial of KN046 in combination with ALK-1 (activin receptor-like kinase-1) antibody developed by Kintor Pharmaceutical Limited, for the treatment of advanced or refractory solid tumors.
In November 2021, the Company entered into a collaboration agreement with Guangzhou MaxiNovel Pharmaceuticals Co., Ltd., for joint clinical cooperation of MAX-40279, a multi-target tyrosine kinase inhibitor independently developed by MaxiNovel, in combination with KN046 for the treatment of gastric cancer and other indications as agreed by both parties.
In November 2021, the Company received an IND approval for KN046 from the NMPA for initiating a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/ gemcitabine in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In December 2021, the first patient was successfully dosed in the U.S. in an open-label and multi-center phase II pivotal clinical trial of KN046 to evaluate efficacy, safety and tolerability of KN046 in subjects with advanced thymic carcinoma.
Events after the Reporting Period and expected milestones for 2022
In February 2022, the first patient was successfully dosed in a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of KN046 to evaluate the efficacy and safety of KN046 in combination with nab-paclitaxel/gemcitabine versus placebo in combination with nab-paclitaxel/gemcitabine, in the treatment of locally advanced unresectable or metastatic PDAC without systemic treatment.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase II clinical trial to evaluate the efficacy, safety, tolerability of KN046 in combination with Inlyta (axitinib) in the treatment of advanced NSCLC.
In February 2022, the Company received an IND approval from the NMPA for initiating a phase I/II clinical trial of KN046 in combination with MAX-40279, for the treatment of advanced or metastatic solid tumors.
KN046+chemo,1L sq-NSCLC: Complete the interim analysis and arrange for the BLA application as planned by mid-2022.
KN046+chemo,1L pancreatic cancer: Enroll in the majority of subjects for Phase III clinical trials.
KN046+Lenvatinib,1L HCC: Plan to start pivotal trial in 2022H2.
KN026
Events during the Reporting Period
We made advancement in evaluating the preliminary efficacy of KN026 for the treatment of HER2 expression in patients with advanced GC or GEJ. Such results were presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.
In August 2021, the first patient was successfully dosed in a phase II clinical trial of KN026 for the neoadjuvant treatment of HER2 positive early or locally breast cancer.
In August 2021, the Company received a notice of approval from the NMPA for the supplementary application for a pharmaceutical change of KN026 for clinical use, which allows KN026 liquid formulation to be used in clinical research. This is the first HER2 bispecific antibody in liquid formulation approved for conducting clinical research in China.
In August 2021, Jiangsu Alphamab Biopharmaceuticals Co., Ltd., the principal operating subsidiary wholly owned by the Company, entered into a licensing agreement with Shanhai JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited ("CSPC"), to develop and commercialize KN026 for the treatment of breast cancer and GC in Mainland China.
We made advancement in evaluating the preliminary efficacy and safety results of KN026 in combination with KN046 in patients with HER2-positive GI tumors. Such results were presented at the ESMO (Free ESMO Whitepaper) Congress 2021.
We made progress in obtaining the preliminary safety and efficacy results of a phase II clinical trial of KN026 in combination with KN046 in patients with metastatic HER2-positive breast cancer. Such research progress was presented at the SABCS 2021.
We made progress in a phase I clinical trial of KN026 for the treatment of patients with HER2-positive metastatic breast cancer. Such research progress was presented at the SABCS 2021.
Events after the Reporting Period and expected milestones for 2022
In January 2022, the Company received an IND approval from the NMPA for initiating a randomized and multi-center phase II/III clinical trial of KN026 to evaluate 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, the phase II clinical trial of KN026 combined with KN046 in the treatment of HER2-positive solid tumors, successfully completed patient enrollment. The interim analysis is expected to be conducted in the second quarter of 2022.
In February 2022, data from a phase I clinical study of the KN026 for the treatment of HER2-positive metastatic breast cancer were published in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In March 2022, the preliminary results of phase II clinical trial of KN026 in combination with KN046 for the treatment of locally advanced unresectable or metastatic HER2-positive solid cancer were accepted for e-poster presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting.
KN046+KN026, Chemo-free, HER2+1L GC: Start the pivotal trial in 2022Q2.
KN035 (Envafolimab)
Events during the Reporting Period
In June 2021, the study design of the ENVASARC pivotal trial conducted in the U.S. for KN035 was presented by TRACON in a poster session at the 2021 ASCO (Free ASCO Whitepaper) annual meeting.
In June 2021, the U.S. FDA has granted orphan drug designation (ODD) to KN035 for the treatment of patients with soft tissue sarcoma. This is the second ODD for KN035 after the first ODD in advanced biliary track cancer and the fourth ODD that we obtained from the FDA.
In September 2021, we obtained an IND approval from the NMPA for KN035 in combination of Lenvatinib for the treatment of patients who have failed or are intolerant of platinum containing chemotherapy and are not suitable for radical treatment with locally advanced metastatic or recurrent non-microsatellite instability-high phenotype/non-DNA deficient mismatch repair endometrial cancer.
In November 2021, we obtained formal conditional approval from the NMPA for marketing KN035 (Envafolimab). The approval is for the treatment of MSI-H or dMMR advanced solid tumors.
In December 2021, the Company, 3D Medicines and Simcere, jointly announced that the first batch of prescriptions for KN035 (Envafolimab), the world’s first subcutaneously injected PD-L1 antibody, has been implemented across China.
KN019
The phase II clinical trial of KN019 for the treatment of rheumatoid arthritis completed the patient enrollment. The final analysis of clinical results is expected to be completed in the first half of 2022.
In 2021, we initiated a clinical study on the bioavailability of KN019 in the switch from intravenous infusion to subcutaneous administration.
KN052
In February 2022, the Company received an IND approval for KN052 from the NMPA for initiating a phase Ia/Ib clinical trial to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and antineoplastic activity of KN052 in the treatment of advanced solid tumors.
JSKN-003
The Company completed the efficacy validation and process development for JSKN-003 in June 2021 and targets to submit IND application in the second quarter of 2022.
Manufacturing Facilities
The facility of Jiangsu Alphamab is designed to house over 40,000L production capacity in total. We obtained a drug production license for the phase I-(1) of our new manufacturing facilities from Jiangsu Drug Administration, on July 6, 2020. Phase I-(2), including product workshop, pilot plant and R&D center, is under construction and expected to be put into operation in the first half of 2022; Phase I-(3) of our new manufacturing facilities has started construction.
Other Highlights
In May 2021, Jiangsu Alphamab entered into a collaboration agreement with Suzhou Alphamab Co., Ltd. for two technology development projects, namely, JSKN003 and the preparation process development project for mGalt1, a key material of conjugation process, and KN062 COVID-19 neutralizing bispecific antibody development project.
In December 2021, the Company was listed as one of the 2021 Top 100 Chinese Pharmaceutical Innovative Enterprise. The Company has been acknowledged as such for the third consecutive year.
In January 2022, the Company was awarded "The Most Valuable Pharmaceutical and Medical Company" award at the Sixth Golden Hong Kong Stocks Awards ceremony.
Financial Summary
For the year ended December 31, 2021，we recorded total revenue of RMB146.0 million. The Group mainly generates revenue from (i) sales of pharmaceutical product; (ii) royalty income; (iii) license fee income; and (iv) goods or consumables for R&D projects.
For the year ended December 31, 2021, the Group’s other income decreased by RMB64.1 million to RMB47.0 million, as compared to RMB111.1 million for the year ended December 31, 2020.
For the year ended December 31, 2021, our R&D expenses increased by RMB150.2 million to RMB481.4 million, compared to RMB331.2 million for the year ended December 31, 2020, primarily due to (i) the increase in the number of ongoing clinical trials; (ii) the expansion of the scale of our clinical studies; (iii) the advancement of clinical trials of our drug candidates; and (iv) the increase in staff cost due to the increase in our R&D staff.