suzhou, china, march 23, 2021 - alphamab oncology (stock code: 9966. hk), reported financial results for the full year ended december 31, 2020 and highlighted recent progress and upcoming milestones.
dr. ting xu, chairman and ceo of alphamab oncology, commented, “2020 is amilestone year for alphamab oncology. the company has been making significant progress with respect to our drug pipeline and business operations. the bla for envafolimab (kn035), potentially the world's first subcutaneous pd-l1 inhibitor, has been accepted in last dec. and was granted priority review; 4 pivotal clinical studies were initiated, 3 products under development were granted orphan drug designation by the u.s. fda, and 9 inds were approved; the bispecific antibody kn046 and kn026 have shown promising data in clinical studies conducted around the world; the company has reached strategic collaborations with 10 domestic and foreign partners including pfizer, sanofi, and institut pasteur of shanghai, chinese academy of sciences; the phase i production lines of our new manufacturing facilities, designed to house over 30,000l capacity in total, obtained drug production license.
in 2021, the company expects to launch its first product, which means the successful transition to commercial stage. at present, the company's fully owned and highly differentiated pipeline products have expanded from 9 to 16. the company has expanded its management team with several senior executives, including dr. johannes nippgen, former head of r&d biopharma in china for emd. this year, our first product, kn035, is going to be on the market and interim results expected from first phase iii for kn046, multiple trial results will be presented at the upcoming international conferences , and a number of new pivotal/registration clinical studies will be launched...the company is fully prepared to meet new opportunities and challenges, we will continue to create value for our patients, our shareholders and society, and strive to fulfill the company's mission and build a healthy and bright future.”
recent business highlights
product pipeline
our highly differentiated pipeline, developed in house, consists of sixteen drug candidates. we have one biologic license application submitted, three in late clinical stage, and two to three in schedule for ind submission in 2021.
kn035 (envafolimab)
potentially the first subcutaneous pd-l1 inhibitor worldwide, offering advantages in safety, convenience, compliance, access to patients not suitable for intravenous infusion, andmore efficient utilization of healthcare resources. the first bla for kn035, accepted by nmpa in december 2020, and is expected to be approved this year.
events during the reporting period
● the company presented clinical trial results of kn035 in patients with advanced tumors with mismatch-repair deficiency and a combination therapy with kn035 plus chemotherapy for advanced gc/gej at the 2020 asco annual meeting.
● on july 16, 2020, we supported tracon, our u.s. partner, to submit an ind application for a pivotal trial for kn035 in the soft tissue sarcoma subtypes (envasarc) of undifferentiated pleomorphic sarcoma and myxofibrosarcoma. on august 14, 2020, tracon received an approval notification from fda that the study may proceed in the united states.
● in december 2020, the first patient was successfully dosed in the envasarc registration trial conducted in the united states.
● on december 17, 2020, the bla for kn035 was accepted by the nmpa. the bla of kn035 is accepted for the treatment of msi-h advanced colorectal cancer, gc/dmmr advanced solid tumors.
events after the reporting period
● in january 2021, kn035 was granted priority review by cde of the nmpa.
kn046
a bsab immune checkpoint inhibitor simultaneously targeting two clinically validated immune checkpoints, pd-l1 and ctla-4, representing a potential breakthrough, next-generation immuno-oncology blockbuster drug. currently, there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc, hcc and pancreatic cancer in australia, china, and the united states. the results from the clinical trials have shown favorable safety profile and efficacy signals of kn046.
events during the reporting period
● on april 15, 2020, jiangsu alphamab received an approval notification from fda that it is safe to proceed with a phase ii clinical trial of kn046 for nsclc in the united states.
● on may 12, 2020, jiangsu alphamab received ind approvals from cde, including the evaluation of the efficacy, safety and tolerability of kn046 in combination with kn026 for her2-positive or her2 expression solid tumors in phase ib clinical study; multi-center, open-label, phase ib/ii clinical trials for ningetinib tosylate in combination with kn046 for the treatment of advanced hcc.
● we presented the preliminary efficacy and safety data of a dose escalation and expansion phase ia/ib clinical trial of kn046 in china in patients who have failed prior immune checkpoint inhibitors at the 2020 america society of clinical oncology (“asco”) annual meeting. the results indicate that kn046 showed a favorable safety profile and promising clinical benefit in advanced solid tumor patients who failed on prior ici therapies.
● on september 2, 2020, fda granted odd to kn046 for the treatment of thymic epithelial tumor.
● on september 3, 2020, jiangsu alphamab officially launched a kn046 pivotal phase ii clinical trial of kn046 for thymic carcinoma in china and the u.s.
● in september 2020, jiangsu alphamab has achieved the first patient dosing in enreach-lung-01. enreach-lung-01 is a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of kn046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous nsclc.
events after the reporting period
● in january 2021, the first patient was successfully dosed in the enreach-thymic registration trial, a pivotal phase ii, open label, multi-center pivotal clinical study to evaluate efficacy, safety and tolerability of kn046 in subjects with thymic carcinoma.
● in january 2021, we presented abstracts on the preliminary efficacy and safety of kn046 in combination with chemo-radiation therapy for the treatment of recurrent and metastatic escc at 2021 asco gastrointestinal cancers symposium annual meeting.
● in february 2021, the first patient dosing of kn046 in combination with donafenib, an orally administered multikinase inhibitor, was accomplished in phase i/ii clinical trials for the treatment of advanced or metastatic hcc.
● we presented clinical data from a phase ii clinical study of kn046 in patients with advanced nsclc at wclc 2020. with a median follow up of 13 months, the median pfs was 3.68 months (95% ci: 3.35, 7.29), among them, squamous nsclc and non-squamous nsclc were 7.29 months (3.68, 9.23) and 3.58 months (2.46, 5.52), respectively, which are numerically higher than historical data for pd-1 therapeutics in chinese patients. it indicates that kn046 was well tolerated and effective as a second-line treatment for advanced nsclc, which indicated promising pfs and os benefits in nsclc.
● we presented preliminary safety and efficacy results of kn046 from a phase i clinical study of kn046 in treatment of patients with rare thoracic tumors at wclc 2020. the confirmed orr was 50%, unconfirmed orr was 75%, and the dcr was 100% in thymic epithelial tumors.
kn026
a next-generation anti-her2 bsab that can simultaneously bind two distinct clinically validated epitopes of her2, resulting in potentially superior efficacy.
events during the reporting period
● on may 12, 2020, jiangsu alphamab received ind approvals from cde for new therapies of kn026, including the evaluation of the efficacy, safety and tolerability of kn046 in combination with kn026 for her2-positive or her2 expression solid tumors in phase ib clinical study; and phase ii clinical study to assess the effectiveness and safety of kn026 in monotherapy or combination therapy for her2 low expression or her2-positive recurrent/mbc.
● we presented the preliminary safety, efficacy and pk results of an open-label, phase i clinical trial of kn026 in china in patients with her2-positive mbc at the 2020 asco annual meeting. the results indicate that kn026 is well tolerated and has demonstrated encouraging anti-tumor activity in her2-positive breast cancer patients who have failed standard anti-her2 therapies.
● we presented preliminary clinical data at the sitc 2020. the combination therapy of kn026 and kn046 (“kn026 kn046 combo”) has achieved positive results in a clinical phase ib trial for the treatment of her2 aberrated solid tumors in patients who have failed standard therapy.
● in december 2020, jiangsu alphamab had successfully dosed the first patient in search-01 study, a phase ⅱ clinical trial of kn026 in combination with kn046. the search-01 trial is an open label, phaseⅱ and multi-center clinical study to evaluate the efficacy, safety and tolerability of kn026 in combination with kn046 for her2-positive solid tumors.
● in december 2020, fda granted odd to kn026 in combination with kn046 for the treatment of her2-positive or low expressing gc or gej. this is the third odd granted to the company by fda.
● in december 2020, our company received from the nmpa the ind approval for combination therapies of kn026 and palbociclib or combination therapy of kn026, palbociclib and fulvestrant for the treatment of her2-positive locally advanced unresectable and/or metastatic breast cancer in patients who have failed the treatment of trastuzumab and taxanes.
other highlights
events during the reporting period
● on may 22, 2020, jiangsu alphamab and inxmed entered into a partnership agreement to jointly develop the combination therapy of kn046 and in10018, a focal adhesion kinase inhibitor, to explore the synergistic effect of the combination of kn046 and in10018.
● on may 28, 2020, jiangsu alphamab and slp entered into a new collaboration agreement to expand the original collaboration, pursuant to which both parties agreed to jointly develop an anti-tumor combination therapy with ct053 (ningetinib toluenesulfonate), a multi-target small molecule inhibitor, and kn046, for human solid tumors.
● on june 9, 2020, jiangsu alphamab and sanofi entered into an exclusive option agreement for the strategic collaboration to advance clinical studies investigating kn026 in combination with sanofi’s product taxotere® in patients with her2 breast cancer.
● on june 10, 2020, the company and institut pasteur of shanghai, chinese academy of sciences (“institut pasteur of shanghai”) entered a cooperative development agreement on the co-development, manufacturing and commercialization of therapeutic antibody for covid-19.
● on june 19, 2020, jiangsu alphamab and sinovent entered into a partnership agreement to jointly develop the combination therapy of kn046 and xnw7201, a small-molecule inhibitor, in oncology indications.
● on july 30, 2020, jiangsu alphamab entered a partnership agreement with kintor pharmaceutical, to jointly develop the combination therapy of kn046 and gt90001 in hcc.
● in july 2020, the company was recognized as one of the first high-tech enterprises in suzhou free trade zone, and foreign-funded r&d center of jiangsu province.
● dr. xu won the sixth “suzhou outstanding talent award” awarded by the suzhou municipal government.
● alphamab oncology (9966.hk) is included in the hang seng composite index.
● at the end of november 2020, we were acknowledged as “chinese pharmaceutical innovation enterprises 100” in the 2020 china healthcare summit of entrepreneurs, scientists and investors.
● our company has been included in the hong kong stock connect list under the shenzhen-hong kong stock connect, with effect from december 28, 2020.
events after the reporting period
● on january 6, 2021, our company was awarded as the “most valuable medical and pharmaceutical company” in the 5th annual awards ceremony of hong kong golden stock held in shenzhen.
● further expansion of alphamab oncology management team, including appointing dr. johannes nippgen as chief medical officer.
facilities
on july 2020, the 2x2,000l production lines of the new manufacturing facilities of jiangsu alphamab, which is designed to house over 30,000l capacity in total, obtained drug production license issued by jiangsu drug administration. these production lines are equipped with world-class equipment that meet the regulatory requirements of nmpa, fda and european medicines agency for gmp.
full year 2020 financial summary
● for the year ended december 31, 2020, the group recorded other income of rmb111.1 million, as compared with rmb34.4 million for the year ended december 31, 2019, mainly include interest income, government grants and other miscellaneous income.
● we recorded other losses of rmb117.6 million for the year ended december 31, 2020, as compared to rmb0.3 million for the year ended december 31, 2019. our loss and total comprehensive expense amounted to rmb427.8 million for the year ended december 31, 2020, as compared with rmb832.7 million for the year ended december 31, 2019.
● the r&d expenses of the group amounted to rmb331.2 million for the year ended december 31, 2020, as compared with rmb166.7 million for the year ended december 31, 2019.
● the administrative expenses amounted to rmb78.2 million for the year ended december 31, 2020 as compared with rmb117.7 million for the year ended december 31, 2019.
for more information, please refer to the company's 2020 annual results announcement published on the hong kong stock exchange and the company's official website.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials or pre-marketing stage in china, the united states, japan and australia. the bla for envafolimab (kn035) has been accepted and granted priority review by the national medical products administration (nmpa).
the company also has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards and a complete quality system which has passed the on-site inspection of an european union qualified person. alphamab oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in china and around the world.
alphamab oncology forward-looking statements
this press release contains statements related to our future business and financial performance and future events or developments involving alphamab oncology that may constitute forward-looking statements. these statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. these statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. we may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. in addition, our representatives may from time to time make oral forward-looking statements. such statements are based on the current expectations and certain assumptions of alphamab oncology’s management and business operation, many of which are difficult to predict and generally beyond alphamab oncology’s control. these are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, alphamab oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and alphamab oncology’s disclosures. should one or more of these risks or uncertainties materialize or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of alphamab oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. other than as required by applicable law, alphamab oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
