Newsroom

 (May 24th, Chengdu and New Jersey) The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Illinois, the United States of America from May 31 to June 4, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) will present two clinical stage study results at ASCO.

1.The Phase 3 OptiTROP-Breast01 study of its anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT) (formerly SKB264/MK-2870) in patients with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC).

?   Session: Special clinical science symposium (Abstract #104; Next-Generation Antibody–Drug Conjugates: The Revolution Continues),

?   Time:  June 2, 2024, 9:45 AM to 11:15 AM local time

2.  The Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with KL-A167 (an anti-PD-L1 mAb) as 1L treatment for patients with advanced non-small cell lung cancer (NSCLC)

?   Session: oral (Abstract #8502; Lung Cancer—Non-Small Cell Metastatic Oral)

?   Time: May 31, 2024, 2:45 PM to 5:45 PM local time.

Sac-TMT is jointly developed by Kelun-Biotech and MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) at clinical stage.

The abstracts for the above studies were published on ASCO’s official website on [May 23, 2024], local time. The study results are summarized as follows:

TNBC

Patients were randomly assigned (1:1) to receive sac-TMT (n = 130) or chemotherapy (n = 133). The median age was 51 years; 87% had visceral metastases; 26% received prior PD-1/PD-L1 inhibitors; 48% received three or more prior lines of chemotherapy for advanced disease. The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95% CI, 0.22 to 0.45; P <0.00001).

The median PFS, as assessed by BICR, was 5.7 months (95% CI, 4.3 to 7.2) with sac-TMT and 2.3 months (95% CI, 1.6 to 2.7) with chemotherapy; PFS rate at 6 months was 43.4% vs 11.1%. In the subset of patients with trophoblast cell-surface antigen 2 (TROP2) H-score > 200, the median PFS was 5.8 months with sac-TMT and 1.9 months with chemotherapy (HR 0.28; 95% CI, 0.17 to 0.48). At the first planned interim analysis for overall survival (OS) (data cut-off: Nov 30, 2023) with median follow-up of 10.4 months, OS was statistically significant in favor of sac-TMT (HR 0.53; 95% CI, 0.36 to 0.78; P =0.0005); the median OS was not reached (95% CI, 11.2 to NE) with sac-TMT and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The objective response rate (ORR) assessed by BICR was 43.8% with sac-TMT and 12.8% with chemotherapy.

Most common grade ≥ 3 treatment-related adverse events (TRAEs) (sac-TMT vs. chemotherapy) were neutrophil count decreased (32.3% vs. 47.0%), anemia (27.7% vs. 6.1%) and white blood cell count (WBC) decreased (25.4% vs. 36.4%).

A Phase 3 global study led by MSD of sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC) in TNBC who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery (NCT06393374) and a Phase 3 study led by the Company of sac-TMT in China for 1L treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC (NCT06279364) are ongoing.

NSCLC

Patients with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive sac-TMT 5 mg/kg Q3W plus KL-A167 1200 mg Q3W (cohort 1A) or sac-TMT 5 mg/kg Q2W plus KL-A167 900 mg Q2W (cohort 1B) in a non-randomized manner until disease progression or unacceptable toxicity. As of January 02, 2024, 40 and 63 patients have been enrolled in cohort 1A and 1B, respectively. Median ages were 63/63 years (cohort 1A/1B); 97.5%/85.7% had Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 1; 30.0%/33.3%, 32.5%/30.2% and 37.5%/36.5% of patients had programmed death ligand 1 (PD-L1) expression < 1%, 1%-49% and ≥ 50% of tumor cells by IHC 22C3 pharmDx assay, respectively.

After median follow up of 14.0 months for cohort 1A, the ORR was 48.6% (18/37, 2 pending confirmation), disease control rate (DCR) was 94.6% and median PFS was 15.4 months (95% CI: 6.7, NE) with a 6-month PFS rate of 69.2%. After median follow-up of 6.9 months for cohort 1B, the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with a 6-month PFS rate of 84.6%. Additional subgroup analyses of cohort 1B are shown in the following table:

*Including confirmed or unconfirmed response. ORR was calculated based on response evaluable population defined as patients with ≥ 1 on-study scans.

In cohorts 1A and 1B, the most common Grade ≥ 3 TRAEs were neutrophil count decreased (30.0%/30.2%), WBC decreased (5.0%/17.5%), anemia (5.0%/15.9%), rash (5.0%/6.3%) and drug eruption (7.5%/0). Treatment-related adverse events leading to discontinuation of sac-TMT occurred in 1 patient of cohort 1B due to drug hypersensitivity, and there were no treatment-related deaths.

Two Phase 3 global studies led by MSD of sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study led by the Company of sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319) are ongoing. Additionally, Three Phase 3 global studies led by MSD of sac-TMT plus pembrolizumab are ongoing: One in patients with 1L Metastatic Squamous NSCLC (NCT06422143) , a second  in patients with metastatic NSCLC expressing PD-L1 ≥ 50% (NCT06170788), and the third in patients with resectable NSCLC not achieving a pathological complete response (NCT06312137) .

On May 16, 2024, Kelun Group celebrated the Group's twenty-eighth birthday. On the occasion of the 28th birthday of Kelun Group, Kelun-Biotech (6990.HK), together with Kelun Research Institute, honored the long-serving employees and celebrated with them. The "28 years of riding the wind together, I grow with Kelun" series of staff activities came to a successful conclusion.

Activity 1: "Cultural Symbiosis" Theme Activity

The "Cultural Symbiosis" activity began with the firm and powerful "Elite Oath" of 170 employees from 34 teams. In the "Culture Lecture - Side by Side - Culture Transmission - Working Together - Dedication to Factory Day" competition, colleagues within the team support each other to work together, the teams learn from each other to catch up with each other, in a pleasant and intense atmosphere to promote the corporate culture, enhance the team cohesion, and match the style of the people of Kelun!

                                                                                                         Highlights of the event

Activity 2: "All the Way" Long-term Service Employee Recognition Ceremony

To fight for the waves, a group of Kelun people have been working together with great expertise. In order to inspire and thank the long-serving employees of Kelun, on May 16th, the Group's birthday, Kelun-Biotech and Kelun Research Institute honored more than 40 employees who have joined Kelun Group for 15 years and above.

At the recognition ceremony, the company management presented each long-service employee with a certificate of honor and a souvenir. Employees are one of the most valuable assets of Kelun, they have traveled with Kelun all the way, not only witnessed the growth of the company, but also promoted the development of the company so far.

Kelun-Biotech also looks forward to more employees joining the ranks of long-term service in the future, witnessing the growth of Colum, meeting more challenges and opportunities together with the company, and becoming the backbone of promoting the development of the company.

"Twenty-eight years of riding the wind together, I grow up with Kelun", all the staff of Kelun-Biotech will be with good wishes for Kelun, and with the company to sail the waves together to make a new chapter!

(stock code: 6990.HK, hereinafter referred to as "Kelun-Biotech" or the "Company") has received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 2 clinical trials for its main product, A400 (also known as KL590586 or EP0031). (also known as KL590586 or EP0031), the Company's main product, has been approved by the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trials.

A400 (EP0031) is a second-generation selective RET inhibitor (SRI) with broad activity against common RET gene fusions and mutations, designed to address clinical needs not met by first-generation SRIs. Targeting RET-driven cancers, next-generation SRIs offer potentially more diverse treatment options and may further improve patient prognosis.

In March 2021, Kelun-Biotech granted an exclusive, paid-up license to Ellipses Pharma Limited ("Ellipses"), a UK-based pharmaceutical company, to develop, manufacture and commercialize A400 (EP0031) in all countries outside of Greater China, North Korea, South Korea, Singapore, Malaysia and Thailand. (EP0031) in all countries except Greater China, Korea, South Korea, Singapore, Malaysia and Thailand.

In June 2022, A400 (EP0031) received FDA approval of an Investigational New Drug (IND) application for a Phase 1/2 trial in patients with RET-altered malignancies.

In November 2023,A400 was granted orphan drug status designation by the FDA for the treatment of RET fusion-positive solid tumors.

In March 2024, A400 was granted Fast Track designation by the FDA for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).

Currently, Kelun-Biotech is conducting a pivotal clinical study of A400 (EP0031) in China in RET-positive NSCLC.

In preclinical studies, A400 (EP0031) demonstrated favorable inhibitory activity against major RET kinases in vitro and in vivo, and A400 (EP0031) also demonstrated good blood-brain barrier penetration in animal models.

Data on A400 (EP0031) shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting showed that, based on the results of its ongoing Phase 1/2 trial, A400 (EP0031) demonstrated good anti-tumor efficacy in patients with advanced RET+ solid tumors, particularly in first- and second- or higher-line advanced RET+ NSCLC, with ORRs of 80.8% and 69.7%. The DCR in both cases was reported to be more than 96%.

At the upcoming 2024 ASCO Annual Meeting, the Company's partner Ellipses will report clinical data from the A400 (EP0031) Phase 1 dose-escalation and extension study conducted in patients with advanced RET variant NSCLC and other oncology treatments who have never been treated with an SRI or prior therapy on June 3, 2024 (local time).

Kelun-Biotech is committed to developing innovative medicines with features and advantages to address global unmet clinical needs, and the company will also accelerate the development of the drug in China and work with its partner Ellipses to advance the global development and commercialization of A400 (EP0031) to benefit more oncology patients around the world.

About Kelun-Biotech

Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.

At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.

In this beautiful season of "wet with apricot blossom rain, not cold with willow wind", the work conference of 2024 Kelun-Biotech was grandly held in Chengdu from April 10th to 12th. Mr. Liu Gexin, Chairman of the Board, Mr. Liu Sichuan, General Manager of the Group, senior management team, relevant persons in charge of each subsidiary (branch) company, each marketing area and all departments directly under the company attended the meeting, and at the same time, the whole meeting was broadcasted in the form of video, with a total number of more than 4,000 people attending the meeting. According to the agenda of the meeting, the 11th was synchronized with the meeting of the industrial sub-groups and marketing sub-groups, and the morning of the 12th was the working conference of the group. A total of 39 speakers made presentations and focused on the short-term and future trends of production and marketing.

The year of 2023 is the year when Kelun resolutely implements the "Twenty Character Guidelines" and continues to move forward victoriously, and the vision and courage of all the fighters extend the road of success of Kelun here. The successful spin-off and listing of Chuanning Biologicals and Kelun-Biotech, Kelun has formed a "character" structure operation platform, and as of March 2024, the total market capitalization has exceeded 100 billion yuan, becoming a pioneering force to lead the industry's high-quality development.

The industrial sub-group meeting focused on safety, quality, cost and other core themes. Kelun Drug Research Institute, Xindu Base, Hunan Kelun, Yueyang Branch, Hubei Kelun, Qionglai Branch focused on research and production linkage, production and marketing linkage, intelligent manufacturing, and high-quality development were comprehensively summarized.

The EHS Supervision Department, a department directly under the headquarters, focused on problems, prevented small steps, strengthened the construction of the safety system and the implementation of responsibilities, and continued to optimize the safety system and strengthen the safety culture with the help of PMS and other management tools. The Cost Management Committee put forward the company's thoughts and requirements on cost management from optimizing cost management, efficient linkage cost reduction, etc., and formulated a cost-saving incentive program, which injected a powerful agent for the production enterprises to continuously reduce costs and increase efficiency. The General Manager's Department made an in-depth summary around the dimensions of solidifying the quality cornerstone, creating an economic supply center, innovation empowerment, and improving quality and efficiency, and made important work plans and deployments in promoting industrial upgrading, and creating a competitive advantage in quality and cost.

The agenda of the meeting was also interspersed with thematic discussion sessions, for the current hotspots and production quality management practices, Internet + safety production, material key attribute assessment and control, supplier control strategy, artificial intelligence and other in-depth discussions, clarifying the management ideas, clearing the direction of the promotion and strategy.

At the end of the theme report, Mr. Liu Gexin, the chairman of the board of directors, commented on the speeches of each theme and pointed out that: soldiers are precious and quick! In the current market environment, through the adjustment of industrial structure, rapid release of production capacity, stabilize market expectations; follow the "Hein's Law", cast product quality shield.

Since its establishment in 2021, under the guidance of the company's "twenty-word policy", Kelun Marketing Center has further improved the company's operational efficiency with reform thinking and innovative approaches. At present, the marketing center is at the intersection of two three-year plans, this meeting comprehensively summarized the first three-year plan and comprehensively deployed the tasks of the second three-year plan.

Core Business Marketing Division, New Drug Marketing Division, Kelun-Biotech Marketing Center, CDMO Business Development Department, Comprehensive Products Division and Large Retail Division analyzed and summarized the sales and market situation of the company's core infusion products and generic innovative products from 2021 to 2023, and put forward the sales planning for 2024 and the long term; Health Strategy Development Research Department, County Business Department, Merchants Department and excellent areas shared the system construction, academic promotion and other multi-dimensional work experience. The Market Access Department, the Integrated Medical Market Department and the Business Department made special reports on the layout of access work, the professional capacity and system construction of academic promotion, and the management of product channels.

After listening carefully to the special report of each spokesman of the marketing sub-group, General Manager of the Marketing Center Fan Wendi made an in-depth and detailed comment, and deployed the second three-year plan of the Marketing Center - Deepening Reform, Steady Transformation, from the four dimensions of organizational optimization and talent cultivation, deepening of the business and comprehensive integration, improving the effectiveness and compliance transformation, and opportunities and problems. He also pointed out that China's pharmaceutical industry has gone through the dilemma of "no drugs available", the market-oriented operation of pulling up seedlings to help them grow, the difficult period of domestic substitution of generic drugs, and the agitation under the innovation dividend, and is now moving towards rationality and maturity. Every day, we must find the long-term trend in the changes and explore new breakthroughs in the unchanged!

Chairman Liu Gexin instructed: the top management has reached a high degree of consensus on the upgrading and transformation of marketing; the ice has been broken, the course has been indicated, and the road has been opened, and we are going to take resolute actions to quickly reach the expected reform goals.

Mr. Deng Xuheng, General Manager of Chuanning Bio, said: Chuanning adheres to the innovative development concept of building industrial alliance in known fields and forming knowledge alliance in unknown fields, and has been at the forefront of the industry in terms of industrial scale, product quality, environmental protection and governance level, and has become the head producer with international discourse power in bulk pharmaceutical raw materials. After listing, Chuanning has focused its resources on the synthetic biology track and completed the research and development of its first synthetic biology product, red myrcene glycol, to commercial production in two years, which fully demonstrated Chuanning's high-quality research and development level and strong industrialization capability. In the future, Chuanning will continue to adhere to the dual-wheel drive strategy of "bio-fermentation" and "synthetic biology", empowering the antibiotic industry and synthetic biology R&D with AI to further consolidate the head position of the traditional antibiotic industry, and at the same time accelerating the research and development and landing of new products, which will contribute to the profitability of Coren Group. At the same time, we will accelerate the research and development of new products, and contribute to the sustainable growth of the profit of Kelun.

On behalf of Kelun Research Institute and Kelun-Biotech, Mr. Ge Junyou, General Manager of Kelun-Biotech, reported the progress of Kelun's drug R&D work in 2023 and the work objectives in 2024, taking into account the current domestic and international regulations and competitive situation. He said: At present, the challenges and opportunities of new drug R&D coexist, Kelun will continue to adhere to the R&D strategy of "Generic drives innovation, innovation drives the future", under the strong and wise leadership of the Chairman, General Manager and the Group, continue to strengthen the full-cycle empowerment of innovative drug R&D by AI technology, focus on key indications and core technology platforms, fully promote international cooperation, and accelerate the development of multiple innovative drugs, as well as the development of new drugs in the future. We will also make every effort to promote international cooperation, accelerate the approval and commercialization of many innovative drugs, maximize the global value of our pipeline, and contribute China's power to the cause of human health!

The awarding ceremony of "The Fifth Group Meeting of Kelun Group" was also held during the meeting, and the top ten outstanding marketing areas in terms of net income and per capita profit for the year of 2023, and the outstanding production enterprises in the "Billion Dollar Club" were awarded respectively. The loyal and brave generals of Kelun marketing business face the challenges with the mindset of accommodating all rivers and the confidence of never giving up; the team will be cohesive as one and the spirit of struggle to achieve the mission frequently show their swords, which is so awe-inspiring and courageous! "It seems to be the most rugged, into as easy but hard", Colum this growing, growing production and technology team, is the foundation and hope for the continued success of the Colum business; it is a group of people who must be cherished and cared for, no matter how it is evaluated will not be too high. We are bold and confident in realizing this year's goal! Let us work together to open a new era of carrying the glory of Kelun, move forward!

Chairman Liu Gexin attended the whole meeting, and after listening to the speeches on industry, marketing, Chuanning Biological and R&D innovation, he put forward opinions and suggestions in light of the actual work and responded to the concerns of all parties.

Chairman Liu Gexin talked about: a bird dares to sing in the fragile branch, why it does not worry about the branch will break? Because it has wings to fly, the enterprise is the same, from the moment of the birth of Kelun, the eagle is our spiritual totem, through the clouds and fog, the eyes of heaven and earth, "Kunpeng wings, ninety thousand miles, turn the shaking goat's horns", which is the ambition of Kelun.

After twenty-eight years of hard work, Coren is at a "high time" that has never been seen before in its history. We must be virtuous and prudent, cautious and fearful; we must adhere to long-termism and value investment, and become a trustworthy company by rewarding investors and society with more excellent results.

In the face of the great changes that have not been seen in a century, embracing change from the bottom of our hearts is the only way to see the opportunities in economic adjustments and business changes. The only way to cope with change is to innovate, which is the essence of entrepreneurship. Success lies not only in talent and luck, but also in the anticipation and selection of quality "tracks", which requires entrepreneurs to have higher wisdom and commitment to explain the present and foresee the future with new knowledge systems and deeper insights. Entrepreneurs' belief in technology, their pursuit of innovation and their confidence in the future are intertwined, and these are great enablers for creating a new era of business.

Whenever we start a new impact, we will seek the regeneration power of "Phoenix Nirvana" from the original civilization of Colum's entrepreneurship, and the spirit of Colum, which is mutually promoting and stimulating, has been honed through the vicissitudes of life and has been deposited in the hearts of Colum's comrades, and will explode when there is a fire.

Today, we are standing on a new starting point, has a completely different state of mind. Warm winds of May will soon blow across the land of China, this is the season belonging to us, since we have chosen a faraway place, we will travel through thick and thin, let's sing for the month of May, and pay homage to those who struggle!

2024 American Association for Cancer Research (AACR) Annual Meeting is being held in San Diego, California, the United States of America from April 5^th to 10^th, 2024, local time.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, the “Company”) will present two study results of anti-TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) during the AACR meeting scheduled below. The abstracts for the studies have been published on the official website of the AACR on April 5^th, 2024, local time (See link below).

1. The updated efficacy and safety results for its anti-TROP2 ADCSKB264/sac-TMT in patients with previously treated advanced non-small cell lung cancer (NSCLC) from a phase 2 study in a poster session scheduled on April 9 2024, 1:30 PM - 5:00 PM local time (Abstract Presentation Number: CT247).

2.The preliminary efficacy and safety results for its anti-TROP2 ADC SKB264/sac-TMT in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer from a phase 2 study as an oral presentation, which is scheduled in a session on April 9 2024, 2:30 PM - 4:30 PM local time (Abstract Presentation Number: CT038).

The study results are summarized as follows:

NSCLC

Patients with previously treated advanced NSCLC were enrolled to receive SKB264/sac-TMT at 5 mg/kg Q2W until disease progression or unacceptable toxicity (KL264-01, NCT04152499). The data cut-off date was November 22, 2023.

Five Phase 3 global studies of SKB264/sac-TMT in patients with NSCLC are ongoing. Including two Phase 3 global studies of SKB264/sac-TMT in patients with 3L+ EGFR mutant NSCLC (NCT06074588), and 2L EGFR mutant NSCLC (NCT06305754) and a Phase 3 study ofSKB264/sac-TMT in China in patients with 2L EGFR mutant NSCLC (NCT05870319). Additionally two Phase 3 global studies of SKB264/sac-TMT plus pembrolizumab in patients with metastatic NSCLC expressing programmed death ligand 1 (PD-L1)≥ 50% (NCT06170788) and resectable NSCLC not achieving pathological complete response (NCT06312137) are ongoing.

As of the Data Cut-off date, 43 NSCLC patients had been enrolled and the median follow-up was 17.2 months. 21 patients with EGFR wild type had received a median of 3 prior regimens of therapy including anti-PD-1/L1 inhibitors. 22 patients with EGFR mutant had progressed on or after TKI therapy, 50% of whom also failed at least one line of chemotherapy. Updated efficacy results are shown in the following:

*Including confirmed or unconfirmed response. Based on response evaluable patients (≥1 on-study scans) with 4 patients (2 EGFR mutant patients with non-squamous histology and 2 EGFR wild type patients with squamous histology) excluded.

The most common Grade ≥3 treatment-related adverse events (TRAEs) were neutrophil count decreased (34.9%), anemia (30.2%), white blood cell (WBC) count decreased (25.6%), stomatitis (9.3%), and rash (7.0%). No TRAEs leading to treatment discontinuation or deaths occurred. No drug-related interstitial lung disease (ILD)/pneumonitis was reported.

Gastric/GEJ cancer

Patients with previously treated inoperable advanced gastric/GEJ adenocarcinoma were enrolled to receive SKB264/sac-TMT monotherapy at 5 mg/kg Q2W until disease progression or unacceptable toxicity in Phase 2 expansion cohort of KL264-01 study (NCT04152499). Patients with heavily pre-treated gastric/GEJ cancer were enrolled first, and then the cohort was amended to enroll patients with only one prior therapy of chemotherapy and anti-PD-1/L1 therapy. The data cut-off date was Nov 22, 2023.

As of the data cut-off date, a total of 48 patients were enrolled and followed up for at least 9 weeks. 24 patients (50.0%) had received one prior line of therapy (2L), while 24 patients (50.0%) had received ≥ 2 prior lines of therapy (3L+). 40 patients (83.3%) had received prior anti-PD-1/L1 inhibitors. Of 41 response-evaluable patients (defined as ≥ 1 on-study scans), the objective response rate (ORR) was 22.0% (9 partial responses, 2 pending confirmation) and disease control rate (DCR) was 80.5%. The ORRs in the 2L and 3L+ setting were 27.3% (including 2 pending confirmation) and 15.8%, respectively. Median duration of response (DoR) was 7.5 months. In the subset of 3L+ patients (n=24 including 54.2% of patients with ≥ 4 prior lines of therapy) with more mature follow-up (median follow up of 14.6 months), the median progression free survival (mPFS) was 3.7 months (95% CI: 2.6, 5.4) and median overall survival (mOS) was 7.6 months (95% CI: 5.3, 15.5).

The most common ≥ Grade 3 TRAEs were anemia (20.8%), neutrophil count decreased (18.8%), WBC decreased (12.5%) and neutropenia (6.3%). No TRAEs leading to treatment discontinuation or deaths occurred. No neuropathy or drug-related ILD/pneumonitis was reported.

A Phase 3 global study of SKB264/sac-TMT monotherapy versus standard of care (SOC) chemotherapy in 3L+ gastric/GEJ adenocarcinoma is being planned.

Press Contact: Xinwei Li, klbio_pr@kelun.com

The World Meteorological Organization mentioned on the Interim Report on the State of the Global Climate 2023 that the year 2023 is the hottest year in the history of mankind since records have been kept, and the global climate is getting warmer and warmer, and the earth that we live on is facing a serious climate crisis, and energy conservation and environmental protection are imminent.

"Earth Hour was initiated by the World Wide Fund for Nature (WWF) in 2007, calling on people to voluntarily turn off their lights for one hour at the end of March each year to protect our planet.

Today, Earth Hour has become the world's largest national environmental event, focusing on the twin crises of nature loss and climate change on a global scale.

As a result of the global effort, by 2023, more than 410,000 hours have been accumulated in the "Hour Bank", an online counter for taking positive action to protect the planet.

Earth Hour 2024 will be held at 20:30pm local time on March 23, 2024, to inspire people in more than 190 countries and regions to take action to protect our common home.

Responding to the call of WWF, Kelun-Biotech actively participates in Earth Hour, and carries out all-round publicity for its employees by posting posters, broadcasting on electronic screens and sending out announcements, advocating employees to participate in the one hour lights out activity at home or in the office area from 20:30 to 21:30 on March 23rd, and encouraging employees to post Earth Hour related articles. At the same time, employees were encouraged to post Earth Hour related social media to call on their friends and relatives to participate in the activity.

Environmental protection is more than just an hour. Outside of the event period, Kelun-Biotech also actively fulfills its corporate social responsibility by practicing sustainable environmental protection and helping to move towards the environmental goal of zero load. For example, in 2023, we will save 680,000kWh of electricity by choosing energy-saving chiller units; save more than 240,000 standard cubic meters of natural gas by optimizing the air-fuel ratio of boilers; and save 35,000 tons of water by renovating some water points with recycled water.

We prefer larger or recyclable packaging, and in 2023, we will replace the outer packaging of 5L chemical reagents for R&D from cartons to plastic baskets, and replace dichloromethane and ethyl acetate from small drums to large iron drums, to effectively reduce waste emissions through control at the source.

We invite you to join us on March 23rd at 20:30 to gather the power of "One Hour", turn off unnecessary lighting, and use small actions to bring about a big change with the heart of fraternity, and build a naturally good and carbon-neutral future together.

About Kelun-Biotech

Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.

At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.

(“Kelun-Biotech” or the “Company”, SEHK: 6990.HK), an innovative TROP2-ADC (SKB264, MK-2870), a randomized, open, multicenter study to evaluate the efficacy of SKB264 in the first-line treatment of chemotherapy in patients with recurrent or metastatic non-resectable triple-negative breast cancer (TNBC) in advanced stages. SKB264 comparing investigator-selected chemotherapy for the first-line treatment of patients with non-surgically resectable recurrent or metastatic triple-negative breast cancer (TNBC) to a randomized, open, multicenter Phase III registry-based clinical study in patients with advanced-stage, non-systemic-treatment-na?ve PD-L1-negative TNBC (the “OptiTROP Breast03 (“OptiTROP Breast03” or “the Study”) was successfully held in Hefei.

This study a clinical trial evaluating SKB264 comparing investigator-selected chemotherapy first-line for the treatment of patients with non-operable resectable recurrent or metastatic triple-negative breast cancer (Protocol No. SKB264-III-11), with the national lead research center being the Affiliated Cancer Hospital of Fudan University, the lead researcher being Prof. Zhi-Min Shao, and the clinical registry numbers being: CTR20240413, NCT06279364, and is currently being rapidly pushed into the group.

Professor Zhimin Shao, Chairman of the conference, said, “It is a great honor to lead the registrational clinical study of ColumboTech SKB264 in triple negative breast cancer. Currently, TNBC is a hot area of clinical research. We believe that based on the excellent performance of TROP2 ADC SKB264 reported in first-line as well as second-line and above treatment of advanced TNBC in triple-negative breast cancer in the previous phase, SKB264 can achieve better clinical results in the first-line treatment of triple-negative breast cancer in China. We sincerely thank all the experts for their active participation in this trial, and hope that through our joint efforts and professional wisdom, we can make positive contributions to this clinical study, and look forward to SKB264 receiving marketing approval as soon as possible for the benefit of more patients”.

Dr. Ge Junyou shared, “Kelun is the world's largest manufacturer of infusion solutions in terms of production scale, the world's largest manufacturer of antibiotic intermediates in terms of production scale, and a leading head enterprise of pharmaceutical innovation in China. Kelun-Biotech carries the champion gene of the Group and adheres to innovation at source.SKB264 is the first TROP2 ADC-like drug in China to enter Phase III and enter NDA registration.SKB264's NDA filing for TNBC backline treatment has been accepted by the State Drug Administration, and the drug has been recognized as a breakthrough therapy by four organizations, and has initiated a number of clinical studies in different indications in addition to TNBC. The drug has also received four breakthrough therapeutic recognitions. We look forward to working together to rapidly advance the OptiTROP Breast03 study and accelerate the marketing process for this indication, which will benefit more breast cancer patients. Thank you for the great support from all the experts!”

Professor Cao Min from Hunan Cancer Hospital shared his detailed experience in terms of center overview and enrollment, case sharing, screening and enrollment process management, and internal and external multi-party collaboration.

Professor Liang Yan from Jiangsu Provincial People's Hospital shared detailed experience from center enrollment, case sharing, subjects in group management and management of common adverse events.

Professor Fan Lei from Fudan University Cancer Hospital gave a detailed presentation on the program design and implementation details of the project.

Under the chairmanship of Prof. Zhimin Shao and Dr. Xiaoping Jin, Chief Medical Officer of Clonbuterol, all the participating experts had a full and enthusiastic discussion on the study design, enrollment criteria of the study population, and the study process, and reached a consensus.

Professor Wang Zhonghua and Prof. Shao Zhimin from the Affiliated Cancer Hospital of Fudan University summarized the meeting at the end and thanked all the experts who participated in the investigator meeting. The investigators' meeting came to a successful conclusion, officially starting a brand-new journey for the OptiTROP Breast03 study. Clonbuterol has been exploring the advantageous areas of ADC technology in depth, and continues to promote the deepening layout of SKB264 clinical research. SKB264 first-line treatment of non-surgically resectable locally advanced, recurrent or metastatic PD-L1 TNBC has also been recognized by the BTD, and Clonbuterol will efficiently and qualitatively complete the registry study, and make joint efforts with the first-line clinical force to bring more hope and gospel to global tumor patients. Gospel.

About Kelun-Biotech:

Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs.

At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/.