On March 21, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives, reported financial results for the full year ended December 31, 2023 and provided a corporate update (Press release, Kineta, MAR 21, 2024, View Source;utm_medium=rss&utm_campaign=kineta-reports-full-year-2023-financial-results-and-provides-corporate-update [SID1234641340]).

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In February 2024, the Company announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. Patients currently enrolled in the trial will be permitted to continue to participate. The Company announced the restructuring as a result of certain investors indicating that they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. In connection with the restructuring, the Company announced that it is exploring strategic alternatives to maximize stockholder value.

"2023 was a productive year for Kineta where we initiated the Phase 1/2 VISTA-101 trial of KVA12123 as monotherapy and in combination with pembrolizumab in cancer patients, and saw promising results, underscoring the potential of KVA12123 as a next-generation immunotherapy. We truly appreciate the efforts of the healthcare professionals, the patients and their caregivers, and the Kineta employees involved in this trial. We look forward to sharing the clinical update in the second quarter and we will continue to explore strategic alternatives that will allow us to continue to pursue our mission of developing transformative immunotherapies for patients with cancer," said Craig Philips, President of Kineta.

RECENT CORPORATE HIGHLIGHTS

Phase 1/2 VISTA-101 Trial of KVA12123 in Patients with Solid Cancer Tumors

Efficacy

Announced positive KVA12123 monotherapy safety data from its ongoing Phase 1/2 VISTA-101 clinical trial in patients with advanced solid tumors.
Monotherapy Dose Escalation (3-300 mg KVA12123 Q2W)
Of 21 patients enrolled, 12 received at least one baseline and one follow up scan.
Best overall response (BOR) in nine of 12 patients is currently stable disease among patients with at least one follow-up scan with a mean duration of 15 weeks.
One patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced a stable disease lasting 28 weeks.
Nine participants remain on-treatment.
Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W).
Of nine patients enrolled, three received at least one baseline and one follow-up scan.
BOR in 2 of 3 patients with at least one follow up scan is:
Stable disease in one CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions.
Partial response in one patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions.
Eight patients remain on treatment.
Biomarkers

Dose-dependent induction of on-target pro-inflammatory cytokines and chemokines.
Dose-dependent increases in non-classical monocytes, CD4+ and CD8+ T cells, and NK cells.
Safety

No dose limiting toxicities (DLTs) observed in any patient at any dose level.
No evidence of cytokine release syndrome in any patient at any dose level.
Conference Presentations

Co-organized the 3rd Annual VISTA Symposium, with Hummingbird Bioscience and Dartmouth Giesel School of Medicine, to be held virtually on March 27, 2024.
Presented clinical and preclinical data on VISTA blocking KVA12123 at the Keystone Symposia of Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance.
Presented new preclinical data on KVA12123 in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Blood Cancer Discovery Symposium.
ANTICIPATED FUTURE MILESTONES

Additional KVA12123 monotherapy safety and efficacy data in Q2 2024.
Initial KVA12123 and pembrolizumab combination therapy data in Q2 2024.
EXPLORATION OF STRATEGIC ALTERNATIVES

In February 2024, the Company announced that it is pursuing strategic alternatives to maximize shareholder value due to certain investors indicating they will not fulfill their April 2024 funding obligation in the previously disclosed private placement financing. As a result, the Company has suspended new patient enrollment into the Phase 1/2 VISTA-101 trial and will not be recruiting patients into either the sixth cohort in the monotherapy arm or the third cohort in the combination therapy arm. Patients currently enrolled in the trial will be permitted to continue to participate. In connection with the restructuring, the Company implemented a workforce reduction of the Company’s workforce of approximately 64% of the Company’s then-current employee base.
2023 FINANCIAL HIGHLIGHTS

Cash position: As of December 31, 2023, cash was $5.8 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $8.6 million net proceeds received from institutional and individual investors and $5.0 million in cash received from the Merck milestone payment in July 2023. As of December 31, 2023, we had $5.8 million in cash, and there is substantial doubt about our ability to continue as a going concern. Based on our current operating plans, we do not have sufficient cash and cash equivalents to fund our operating expenses and capital expenditures for at least the next 12 months from the filing date of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which we expect to file on March 21, 2024.
Revenues: Total revenues were $5.4 million for the year ended December 31, 2023 and $2.0 million for the year ended December 31, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement, which triggered a $5.0 million milestone payment. Revenues in 2022 were due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022, and also due to services provided under a grant that was concluded in December 2022.
Research and development (R&D) expense: R&D expenses were $9.0 million for the year ended December 31, 2023 and $15.9 million for the year ended December 31, 2022. The decreases in R&D expenses were primarily due to lower activities for KVA12123 manufacturing and clinical study start up as the Company began enrolling the first patient in the study, which occurred in April 2023.
General and administrative expense: General and administrative expenses were $12.1 million for the year ended December 31, 2023 and $8.7 million for the year ended December 31, 2022. The increase was primarily due to increases in personnel costs of $2.3 million and insurance and other company expenses of $1.1 million. Personnel costs increased due to higher salaries and benefits of $1.2 million from increased headcount to support public company responsibilities and higher stock-based compensation of $1.0 million, which increased due to options granted during 2023. Insurance and other company expenses increased primarily due to public company directors and officers insurance premiums of $601,000 and board fees of $270,000.
Net loss: Net loss was $14.1 million, or $1.28 per basic and diluted share, for the year ended December 31, 2023 compared to a net loss of $63.4 million, or $12.87 per basic and diluted share, for the year ended December 31, 2022.

On March 21, 2024 Biosion, a global, clinical-stage biotechnology company, reported upcoming presentations of pre-clinical data for its oncology pipeline assets, including BSI-111, an anti-CD16a monoclonal antibody, BSI-730, a HER2/PD-L1 bispecific antibody and BSI-093, an anti-BTN3A monoclonal antibody at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held from April 5 to 10, 2024 (Press release, Biosion, MAR 21, 2024, View Source [SID1234641359]).

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"We are thrilled to present three posters at the AACR (Free AACR Whitepaper) annual meeting. BSI-093, BSI-111 and BSI-730 demonstrate favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies" said Mingjiu Chen, Ph.D., Founder and Chief Executive Officer of Biosion, Inc. "We look forward to sharing the key data of these important therapeutic assets with the oncology research community at AACR (Free AACR Whitepaper)."

01. BSI-111, a highly selective anti-CD16a monoclonal antibody with potent agonist activity for building a NK cell engager platform

BSI-111 is a fully human monoclonal antibody discovered through Biosion’s proprietary H³ Antibody Discovery Platform. BSI-111 binds specifically to CD16a without recognizing CD16b and binds the two allelic variants of CD16A – 158F and 158V with similar high affinity. BSI-111 demonstrates superior biophysical properties and functional characteristics, supporting the development of anti-CD16a-based NK cell engagers for the potential benefit of cancer patients.

Time：April 8, 2024, 9:00 AM – 12:30 PM
Location: Poster Section 2
Poster Board Number: 26
Published Abstract Number: 1343

02. BSI-730, a bispecific antibody targeting HER2 and PD-L1 for the development of a first-in-class bispecific ADC

BSI-730 is a novel bispecific antibody for the development of a first-in-class bispecific ADC，identified through Biosion’s proprietary SynTracer High Throughput Endocytosis Platform. BSI-730 showed comparable binding affinity to HER2 as compared to trastuzumab, as well as comparable bioactivity to the parental anti-PD-L1 antibody regarding PD-L1 binding and PD-1/PD-L1 blocking.

Time：April 8, 2024, 1:30 PM – 5:00 PM
Location: Poster Section 21
Poster Board Number: 16
Published Abstract Number: 3135

03. BSI-093, a best-in-class anti-BTN3A monoclonal antibody for the treatment of cancer through the activation of Vγ9Vδ2 T cells

BSI-093 is a highly differentiated, humanized anti-BTN3A agonistic monoclonal antibody with strong Vγ9Vδ2 T cell activation activity. The BTN3A family including BTN3A1, BTN3A2 and BTN3A3 are members of the Ig superfamily receptors, and is essential for the activation of Vγ9Vδ2 T cell-mediated anti-tumor immune responses. BTN3A’s expression is significantly higher in tumor samples of cholangiocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, compared to their counterpart normal tissue controls.

Time：April 9, 2024, 1:30 PM – 5:00 PM
Location: Poster Section 3
Poster Board Number: 7
Published Abstract Number: 5298

Additionally, Biosion’s partner, CTTQ Pharma, OBI Pharma and Pyxis Oncology, will also be presenting posters at the AACR (Free AACR Whitepaper) meeting.

Partner：CTTQ

A first-in-human phase 1 study of TQB2916, a novel CD40 agonist antibody for advanced malignancies

TQB2916（BSI-038） is an anti-CD40 humanized agonist monoclonal antibody with 7-fold higher binding affinity and 4-fold higher cellular bioactivity compared to selicrelumab. By binding to CD40 receptor, it triggers the cellular proliferation and activation of antigen-presenting cells. In 2019, Biosion licensed Greater China rights of BSI-038 to CTTQ and retains all rights for development and commercialization in the rest of the world.

Time：April 9, 2024, 9:00 AM – 12:30 PM
Location: Poster Section 48
Poster Board Number: 20
Published Abstract Number: CT192

Partner：OBI Pharma

1. OBI-992, a novel TROP2 targeting antibody-drug conjugate, displayed excellent antitumor efficacy in various animal models

Time：April 8, 2024, 9:00 AM – 12:30 PM
Location: Poster Section 23
Poster Board Number:4
Published Abstract Number:1893

2. In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992

Time：April 8, 2024, 1:30 PM – 5:00 PM
Location: Poster Section 21
Poster Board Number: 11
Published Abstract Number:3130

3. OBI-992, a novel TROP2 targeting antibody drug conjugate demonstrates superior in vivo PK/PD properties and a favorable safety profile

Time：April 10, 2024, 9:00 AM – 12:30 PM
Location: Poster Section 24
Poster Board Number: 20
Published Abstract Number: 7179

OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy.OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models.

OBI-992 received US IND clearance in December 2023 and Phase 1/2 efficacy and safety human studies are planned to commence early Q2,2024.

The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com, in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992.

Partner：Pyxis Oncology

Gene expression correlation of immune checkpoint molecules Siglec-15 and PD-L1 varies widely by cancer indication

TIME：April 8, 2024, 9:00 AM – 12:30 PM
Location: Poster Section 3
Poster Board Number: 24
Published Abstract Number: 1373

PYX-106 (BSI-060T) is a humanized anti-Siglec-15 monoclonal antibody being developed for solid tumors, including for patients that are not candidates for anti-PD-(L)1 treatment approaches. In this research, analysis of Siglec-15 mRNA expression was performed across single cells, cell lines, and bulk tumor samples to evaluate Siglec-15 target expression across a range of cancer types, including non-small cell lung cancer (NSCLC), cholangiocarcinoma, breast, thyroid, head and neck, colon, rectal, bladder, kidney, and endometrial cancers. These results demonstrate that Siglec-15 and PD-L1 are rarely found co-expressed on the same cell, provide detailed data on Siglec-15 and PD-L1 expression patterns by cancer type, and are expected to help inform potential future PYX-106 (BSI-060T) therapeutic strategies.

In Mar 2022, Biosion licensed ex-Greater China rights of BSI-060T to Pyxis Oncology and retains all rights for development and commercialization in Greater China. Pyxis Oncology is conducting a Phase 1 clinical study of PYX-106 (BSI-060T) in solid tumors in the US and Europe.

On March 21, 2024 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and fourth-quarter and full-year 2023 financial results (Press release, Kronos Bio, MAR 21, 2024, View Source [SID1234641341]).

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"In 2023, we made great progress across our portfolio and business. We demonstrated that KB-0742 has a safety profile that is clearly differentiated from all other CDK9 inhibitors, and we believe our extended dosing schedule will show increased efficacy signals while maintaining a favorable safety profile," said Nobert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We also announced our second development candidate, KB-9558, which is designed to target the KAT domain of p300 and downregulate IRF4 transcription in multiple myeloma. We are looking forward to completing the IND-enabling studies in 2024 and expect to dose our first patients in the first half of 2025."

Clinical Program and Recent Company Updates

KB-0742
•At the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, the Company reported target engagement, tumor regressions, and an acceptable safety profile for KB-0742 dosed at 60mg three-days-on, four-days-off in heavily pre-treated patients with transcriptionally addicted solid tumors. Out of fourteen "all-comer" patients, two patients with myxoid liposarcoma exhibited tumor regressions: one (7th line) had a partial response (per RECIST v1.1) lasting 113 days and the second achieved a 26% reduction in tumor diameters with stable disease. KB-0742 also cleared the 80mg three-days-on, four-days-off schedule in dose escalation and is currently enrolling patients in the KB-0742 60mg four-days-on, three-days-off dose escalation cohort of the Phase 1/2 trial.
•At a medical conference in mid-2024, the Company intends to share an update on the clinical data to date from patients with transcriptionally addicted tumors who were dosed with 60mg three-days-on, four-days-off, and from "all-comer" patients in the dose-escalation cohort who received 80mg three-days-on, four-days-off.
•In the third quarter of 2024, the Company expects to clear the 80mg four-days-on, three-days-off dose escalation cohort, and begin enrolling patients in an expansion cohort including one or more of the following: non-small cell lung cancer, small cell lung cancer, ovarian cancer, and triple negative breast cancer.

Exhibit 99.1
•The Company expects to announce topline data from the expansion cohort at the 80mg four-days-on, three-days-off dose in the first half of 2025.

KB-9558
•In December 2023, the Company announced the nomination of KB-9558, a p300 KAT inhibitor, as a development candidate.
•KB-9558 is the second development candidate to emerge from Kronos Bio’s product engine, where the Company identified that inhibition of the lysine acetyltransferase (KAT) domain on p300 inhibits expression of interferon regulatory factor 4 (IRF4) and thus collapses the transcription regulatory network that is required for the survival of multiple myeloma cells.
•The Company plans to present data on KB-9558 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, being held from April 5-10, 2024 in San Diego, California, including how targeting p300’s enzymatic KAT domain can selectively downregulate IRF4.
•Pending completion of IND-enabling studies in 2024, the Company intends to initiate a first-in-human trial in relapsed or refractory multiple myeloma in the first half of 2025.

Lanraplenib
•In December 2023, after a review of data from the Phase 1b portion of its Phase 1b/2 trial of lanraplenib in combination with gilteritinib in FLT3-mutated relapsed/refractory acute myeloid leukemia (AML), the Company decided not to proceed to Phase 2.

Company Update
•Kronos Bio extended its expected cash runway by a year, into the second half of 2026, through restructurings and resource optimization.

Fourth-Quarter and Full-Year 2023 Financial Highlights

Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $175.0 million in cash, cash equivalents and investments as of December 31, 2023, the Company anticipates sufficient resources to fund its planned operations into the second half of 2026.

R&D Expenses: Research and development expenses were $18.7 million for the fourth quarter of 2023, which includes non-cash stock-based compensation expense of $2.5 million. For the full year of 2023, research and development expenses were $86.4 million, which includes non-cash stock-based compensation expense of $12.0 million.

G&A Expenses: General and administrative expenses were $10.9 million for the fourth quarter of 2023, which includes non-cash stock-based compensation expense of $2.7 million. For the full year of 2023, general and administrative expenses were $41.7 million, which includes non-cash stock-based compensation expense of $13.0 million.

Net Loss: Net loss for the fourth quarter of 2023 was $25.3 million, or $0.43 per share, including non-cash stock-based compensation expense of $5.2 million. Net loss for the full-year 2023 was $112.7 million, or $1.95 per share, including non-cash stock-based compensation expense of $25.0 million.

On March 21, 2023 Henlius (2696.HK) reported its 2023 annual results. During the reporting period, Henlius’ revenue reached about RMB5.3949 billion, representing an increase of 67.8% YoY, and recorded a net profit of RMB546.0 million (Press release, Henlius Biopharmaceuticals, MAR 21, 2024, View Source [SID1234641360]). This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits in H1 2023. The full year of profitability is due to increasing commercial sales of the core products and expanding sales volume. Henlius’ products achieved total sales of approximately RMB4.5535 billion in 2023, up by 70.2% YoY.

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Up to date, Henlius has 5 products launched in China, 2 launched in overseas markets, 19 indications approved worldwide, benefiting over 560,000 patients and reaching more than 40 markets in Asia, Europe, Latin America and Oceania. Besides, over 50 marketing applications of its products have been accepted for review in countries and regions including China, the EU, the U.S., Canada, Singapore and Thailand. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. In 2023, the company’s R&D expenditure reached approximately RMB1.4336 billion.

Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius achieved remarkable performance and recorded full-year profits for the first time. Through unwavering innovation and outstanding execution, we have established a solid foundation for high-quality development and have been continuously improving the efficiency of our integrated biopharmaceutical platform, enabling the company to accelerate its development. Furthermore, we’ve boosted efficiency in operations and management across the business, driving steady and strong growth and inspiring us to build an innovative global biopharmaceutical company with high-quality development."

Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: "Under the dual-drive strategy of ‘biosimilars and novel biologics’, Henlius continues to accelerate both domestic and overseas market expansion, stick to lean operations, promote high-quality and synergistic product development, increase profitability and further advance its comprehensive capabilities. In the future, we will adhere to patient-centricity, further optimize our innovation layout, expand the global distribution of high-quality biological drugs, and make greater contributions to improving human health and well-being."

Achieving strong growth in commercial performance and making new breakthroughs in overseas expansion

In 2023, Henlius has made achievements in product commercialization, business models construction, market layout optimization and overseas market expansion. Its five products achieved total sales revenue of approximately RMB4.5535 billion. HANQUYOU (trastuzumab, trade name in Europe: Zercepac), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB2.7370 billion, RMB1119.8 million and RMB119.4 million, respectively. In addition, the company received sales revenues of RMB540.5 million and RMB58.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.

Henlius’ core oncology product HANQUYOU continues to unleash strong growth momentum. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB2.6444 billion, up by 56.1% YoY. Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefiting over 180,000 Chinese patients to date. Overseas revenue from product sales recorded RMB92.6 million approximately, up by 162.3% YoY. As one of the pioneers of domestic biopharmaceuticals going global, HANQUYOU has successfully been approved for marketing in over 40 countries and regions, including the United Kingdom, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, etc., becoming the China-developed biosimilar with the most marketing approvals. Meanwhile, the product’s accessibility has been further improved. It is now reimbursed nationally in countries including China, the UK, France, and Germany. In 2023, the overseas commercialization of HANQUYOU managed to include the markets of Thailand, the Philippines and Brazil, and its marketing applications in the United States and Canada have also been accepted and expected to be approved for marketing in 2024.

Henlius’ innovative product HANSIZHUANG, the world’s first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China and Indonesia. In 2023, HANSIZHUANG has recorded a total sales revenue of RMB1119.8 million, representing an increase of 230.2% YoY. Up to now, it has been approved for 4 indications and in 2023, it was approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC), benefiting over 60,000 Chinese patients to date. Additionally, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). On the other hand, Henlius continues to expand HANSIZHUANG’s global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. Furthermore, the company submitted marketing applications for HANSIZHUANG in Thailand, Singapore, Malaysia to further promote the product in Southeast Asia. In March 2023, HANSIZHUANG’s Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to further support the Biologic License Application (BLA) in the U.S. Henlius is also advancing HANSIZHUANG-based tumour immuno-combination therapies and has initiated over 10 clinical trials worldwide.

In 2023, the company achieved a number of milestones in business development, boosting new vitality in global expansion for its products. During the reporting period, Henlius earned approximately RMB841.4 million in overseas licensing and other revenues, an increase of 56.0% YoY. In 2023, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. Moreover, the company expanded its collaboration with KGbio to commercialize HANSIZHUANG in 12 MENA countries. It also deepened collaboration with Intas to commercialize HANSIZHUANG in over 50 countries in Europe and India. Up to now, the company has collaborated with international partners such as Accord, Abbott, Eurofarma, Elea and KGbio to globalize its 8 products including HANLIKANG, HANQUYOU and HANSIZHUANG, covering mainstream biopharmaceutical markets in Europe, the United States, and numerous emerging markets, further expanding its global presence.

Charting innovation and improving global supply with enhanced quality and efficiency

As an innovative global biopharma company, Henlius has always been guided by clinical needs and collaborated with its global innovation centres and product development teams to continuously boost innovation and build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market. Currently, its product pipeline covers more than 50 molecules including mAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, and has conducted over 30 clinical studies for 16 products worldwide.

In 2023, the company has accelerated many international multi-centre phase 3 clinical researches of HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with plans to submit marketing applications worldwide in 2024. On the other hand, the latest clinical results for HANSIZHUANG, HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb), HLX26 (anti-LAG-3 mAb), HLX42（EGFR ADC）and HLX43（PD-L1 ADC）have been presented to global academic community, including Nature Medicine, Cancer cell, 2023 ASCO (Free ASCO Whitepaper), 2023 ESMO (Free ESMO Whitepaper), 2023 ESMO (Free ESMO Whitepaper) Asia and gained wide recognition.

Moreover, the company is actively exploring novel targets and mechanisms, constantly expanding into more disease areas and molecular types, so as to accelerate the development of innovative medicines to address complex diseases. Henlius is promoting a number of potential first/best-in-class products, including HLX42 , HLX43 , HLX6018 (anti-GARP/TGF-β1 mAb) and HLX99 (polypharmacology) to enter into clinical/clinical registration filing stage. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products. The company is also accelerating the introduction of innovative products that have multiplier effects with its existing pipeline to drive growth, and has recently acquired the China rights of a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global phase 3 clinical development, bringing more effective and targeted solutions to more patients.

In 2023, Henlius continued building an integrated and comprehensive production platform, enhancing its global supply system to support the company’s worldwide commercial layout and to provide inclusive healthcare for patients. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current commercial capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2023, the Songjiang Second Plant completed the construction and validation of two major buildings and the first engineering run. Henlius benchmarks the highest international standards to construct its quality management system. It has passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. Both Xuhui Facility and Songjiang First Plant have been granted with China and the EU GMP certificates. In 2023, the company’s manufacturing facilities successively obtained GMP certificates from PIC/S member Indonesia and Brazil for products including HANQUYOU, HANSIZHUANG, and HANLIKANG, and were granted EU GMP certificate for the production lines of HANSIZHUANG. Additionally, the Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU.

Adhering to patient-centricity, Henlius will further strengthen its commercialization capabilities as a biopharma, deepen its global strategic presence, drive high-quality innovation, and continue to improve the quality and efficiency of its manufacturing operations, so as to achieve a leap from rapid growth to high-quality development, enabling more high-quality innovative outcomes to benefit more patients worldwide.

On March 21, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) (Press release, Merck & Co, MAR 21, 2024, View Source [SID1234641342]).

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In the KEYLYNK-006 trial, KEYTRUDA in combination with chemotherapy followed by KEYTRUDA plus maintenance LYNPARZA did not meet the study’s pre-specified statistical criteria for OS or PFS compared to KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by KEYTRUDA plus maintenance chemotherapy (pemetrexed). The safety profiles of KEYTRUDA and LYNPARZA in this trial were consistent with those observed in previously reported studies for the individual therapies. A full evaluation of the data from this study is ongoing. Merck will work with investigators to share the results with the scientific community.

"As lung cancer continues to be the leading cause of cancer death worldwide, we are committed to exploring KEYTRUDA-based combinations and novel candidates that may further help improve patient outcomes," said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. "These results are an important reminder of how challenging it may be to treat these patients with metastatic nonsquamous non-small cell lung cancer. We sincerely thank the patients and investigators for their important contributions to this study."

About KEYLYNK-006

KEYLYNK-006 is a randomized, open-label, two-phase Phase 3 trial (ClinicalTrials.gov, NCT03976323) evaluating KEYTRUDA in combination with chemotherapy (pemetrexed plus carboplatin or cisplatin) followed by either KEYTRUDA plus maintenance LYNPARZA or KEYTRUDA plus maintenance chemotherapy (pemetrexed) for the first-line treatment of patients with metastatic nonsquamous NSCLC with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or proto-oncogene tyrosine-protein kinase (ROS1) genomic tumor aberrations. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) and OS. The secondary endpoints include safety and health-related quality of life assessments. The trial enrolled an estimated 1,005 patients in the Induction Phase and randomized 672 patients with a complete or partial response or with stable disease. In the Induction Phase, patients received KEYTRUDA (200 mg intravenously [IV]) in combination with pemetrexed plus investigator’s choice of platinum chemotherapy, consisting of either carboplatin Area Under the Curve (AUC) (5 mg/mL/min IV) or cisplatin (75 mg/m2 IV) every three weeks (Q3W) for four cycles. In the Maintenance Phase, patients with a complete or partial response or with stable disease after completing four cycles of induction therapy were randomized to receive either KEYTRUDA (200 mg IV Q3W for up to 31 cycles) plus maintenance LYNPARZA (300 mg orally twice daily) or KEYTRUDA (200 mg IV Q3W for up to 31 cycles) plus maintenance pemetrexed (500 mg/m2 IV Q3W) until progressive disease, physician decision or intolerable toxicity.

About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In 2024, the overall five-year survival rate for patients diagnosed with lung cancer is 25% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.