Adela to Present Data from Tissue-Agnostic MRD Assay at the American Association for Cancer Research Annual Meeting 2024

On March 19, 2024 Adela, Inc., an innovator in blood testing for minimal residual disease monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 5-10, 2024 from its tissue-agnostic minimal residual disease (MRD) assay (Press release, Adela, MAR 19, 2024, View Source [SID1234641278]). These data demonstrate the feasibility of the assay for cfDNA cancer signal quantification and prognostic prediction in HPV-positive and HPV-negative head & neck cancers following treatment. Data will also be presented on the analytical performance of Adela’s platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition, Daniel De Carvalho, Ph.D., Adela’s Chief Scientific Officer, has been selected to serve as Chair of the Plenary Session "Discovery Science in Early Cancer Biology and Interception". Dr. De Carvalho will also present in the session "New Liquid Biopsy Technologies for Detection and Characterization of Cancer".

Adela plans to commercialize its first product, a tissue agnostic test for minimal residual disease (MRD) monitoring, in 2025. The product will be based on Adela’s genome-wide methylome enrichment platform, which utilizes the company’s patented technology, cfMeDIP-seq, originally developed by Dr. De Carvalho at University Health Network’s Princess Margaret Cancer Centre, in collaboration with investigators at Sinai Health System. Adela’s technology efficiently captures extensive, biologically-relevant genomic information to maximize test performance and improve treatment decisions. It can be applied across the entire cancer care continuum and is initially being developed for MRD and multi-cancer early detection.

Presentation Details

Abstract # 2427: The development of a tissue-agnostic genome-wide methylome enrichment MRD assay for applications across the cancer care continuum for head and neck malignancies
Geoffrey Liu1
Mon Apr 8, 2024 9 am-12:30 pm PT
Section 40 Poster Board Number 23

Abstract # 5024: Analytical performance of a genome-wide methylome enrichment platform to detect minimal residual disease from plasma-derived cell-free DNA
Hestia Mellert2
Tues Apr 9, 2024 9am – 12:30pm PT
Section 40 Poster Board Number 11

Discovery Science in Early Cancer Biology and Interception
Dr. Daniel De Carvalho (Chair)
Sat April 6, 2024 4:15 PM PT
Hall GH

New Liquid Biopsy Technologies for Detection and Characterization of Cancer Dr. Daniel De Carvalho
Tues April 9, 2024 12:30 – 2:00 PM PT
Ballroom 20 CD

TCBP Announces Exercise of Series D Warrants For Cash

On March 18, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that an institutional investor has exercised cash only warrants represented 623,750 American Depository Shares (ADS) at an exercise price of $2.02 (Press release, TC Biopharm, MAR 18, 2024, View Source [SID1234641238]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The gross proceeds of the warrant exercise was $1,263,000 with a net cash infusion of $1,168,275 to the Company post fees associated with the exercise to HC Wainwright & Co. There was no additional consideration or inducement paid for the exercise of the Series D warrants in this transaction. The Company intends to use the cash for additional working capital.

"This transaction is further reflective of the promise of TCB-008 and The Company as whole," stated CEO Bryan Kobel. "We will continue to execute on our 2024 plan, driving to human data in AML as well as expanding our platform. This cash infusion further strengthens our balance sheet and is an example of the institutional investor interest the Company is garnering around it’s clinical programs and the therapeutic applications for TCB-008."

KeChow Pharma Announces NMPA Approval of Tunlametinib (HL-085) as the First Targeted Therapy for Patients with NRAS Mutated Advanced Melanoma and Previously Treated with PD-1/PD-L1

On March 18, 2024 KeChow Pharma, a commercial-stage pharmaceutical company focused on developing and commercializing differentiated small molecule therapeutics for cancer, reported that the China National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with NRAS mutated advanced melanoma who were previously treated with PD-1/PD-L1 (Press release, Kechow Pharma, MAR 18, 2024, View Source [SID1234641239]). This is the first approved targeted therapy for this patient population and the first product originated from KeChow’s in-house research and development activities since the company’s inception.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new drug application (NDA) of tunlametinib was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA. The approval was based on the results of a multicenter, single-arm, phase II, pivotal registrational study which conducted in 100 patients in China (NCT 05217303). Clinical efficacy data of tunlametinib in China, as assessed by independent radiological review committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, include an overall response rate (ORR) of 35.8%, median progression free survival (PFS) of 4.2 months, and disease control rate (DCR) of 72.6%. Subgroup analysis showed that in patients who had previously received immunotherapy, the ORR was 40.6%. The most common treatment-related skin event was rash (53%), followed by dermatitis acneiform (24%). The most common grade ≥3 TRAE in this study was blood creatine phosphokinase increased (38.0%), which was mostly asymptomatic and manageable with dose modification [1].

"We are excited and proud of this major milestone for KeChow. Tunlametinib, approved in China, is the first internally designed and developed molecule by KeChow team ." said Dr. Hongqi Tian, Founder, Chief Executive Officer and Chairman of KeChow. "The approval of tunlametinib is an important milestone to provide new treatment option for Chinese patients with NRAS-mutated advanced melanoma who previously received PD-1/PD-L1. We would like to express our sincere gratitude to the clinicians and patients who participated in our trials, and we thank the health authorities for their strong support. We are committed to making tunlametinib available in China as soon as possible to serve this patient population."

"We own the worldwide rights to tunlametinib. KeChow has a comprehensive clinical development plan to evaluate tunlametinib as a monotherapy and in combination with other standard of care therapies to treat multiple cancers including melanoma, neurofibromatosis type 1–related plexiform neurofibromas, colorectal cancer, and non-small cell lung cancer in China," said Dr. Hongqi Tian. "We look forward to expanding the product potential of tunlametinib through establishing partnerships on a worldwide basis."

Melanoma is one of the most common cutaneous cancers. There are an estimated 20,000 newly diagnosed melanoma patients in China each year [2]. NRAS mutations accounted for 10.4~12.6% of melanoma patients in China [3], and 15-25% globally [4-7]. NRAS-mutated melanoma is more aggressive and associated with poorer outcomes [8-11]. There were no approved targeted therapies for patients with NRAS-mutant melanoma. Tunlametinib is the first small molecule drug approved for this indication.

About tunlametinib

Tunlametinib is a small molecule inhibitor of Mitogen-activated protein kinase kinase (MEK) discovered and developed by KeChow. Tunlametinib targets the Mitogen-activated protein kinase (MAPK)/extracellular regulated protein kinases (ERK) signaling pathway (also known as RAS/RAF/MEK/ERK signaling pathway) by inhibiting the activity of MEK kinase, blocking downstream signaling pathways, inhibiting the growth and proliferation of tumor cell. MAPK/ERK signaling pathway plays a critical role in cancer cell proliferation and apoptosis. Aberrant activation of this signaling pathway has been implicated in more than one-third of all malignancies. Compared to other approved MEK inhibitors, tunlametinib demonstrated stronger target inhibition and improved pharmacokinetic properties.

Breakthrough in Treatment of Cervical High-Grade Squamous Intraepithelial Lesion: Release of Positive Results from Multicenter Phase III Global Clinical Study

On March 18, 2024 Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical leader in the discovery, development, and commercialization of innovative drugs for genitourinary tumors and related diseases reported that the multicenter Phase III global clinical study data of its non-surgical treatment for cervical HSIL product APL-1702 demonstrated significant efficacy and good safety profile, with new advancements in clearance rate of high-risk HPV16 and/or HPV18 (Press release, Asieris Pharmaceuticals, MAR 18, 2024, View Source [SID1234641240]). Key data from the study were presented in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

APL-1702 is a pioneering cold light photodynamic drug-device combination product, used as a non-surgical therapy for treating cervical HSIL. This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment. The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Response is defined as the conversion of cervical epithelial tissue pathology to normal or the conversion to low-grade squamous intraepithelial lesion (LSIL) while achieving baseline HPV clearance.

According to the study results, between November 2020 and July 2022, a total of 402 eligible patients from various countries including China, Germany, the Netherlands et al. were randomized and enrolled in this study. The response rate in the APL-1702 treatment group showed a statistically significant improvement of 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to that in the placebo control group, indicating a remarkable therapeutic effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the APL-1702 treatment group compared to the control group (31.4% vs. 15.4%)[1]. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the treatment group and the control group, with the majority being mild and self-healing without requiring intervention. The occurrence rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were both low in both groups[2].

According to the "Global Cancer Statistics 2020" report, there were 604,127 new cases of cervical cancer in women worldwide in 2020, with 341,831 deaths, ranking it as the fourth most common cancer among women. Cervical cancer incidence ranks second among malignant tumors in Chinese women. According to the "National Cancer Report 2024" released by the National Cancer Center, there were 150,700 new cases of cervical cancer in China in 2022, with 55,700 deaths from cervical cancer.

The main cause of cervical cancer is persistent infection with human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years[3]. According to Frost Sullivan analysis, it is projected that by 2030, the number of HSIL patients worldwide and in China will reach 16.6 million and 2.2 million, respectively. With the increasing popularity of dual-cancer screening and cervical cytology tests, more and more patients with cervical precancerous lesions are being detected at early stages before cancer develops, and it is expected that the number of patients will continue to increase.

Women with cervical precancerous lesions have unmet clinical needs for non-surgical therapies. Currently, invasive procedures such as loop electrosurgical excision procedure (LEEP) and cold knife conization remain the primary treatment options for high-grade cervical lesions. However, these surgical treatments are associated with adverse reactions including bleeding, infection, and cervical structural damage, which may lead to complications such as preterm birth and miscarriage. Furthermore, cervical precancerous lesions require long-term monitoring and management because even after surgical treatment, there is a risk of persistent disease or recurrence, with a higher risk of developing cervical cancer compared to the general population (5 times higher risk of invasive cancer within 10 years). Therefore, post-operative follow-up for at least 25 years is necessary. Importantly, if cervical precancerous lesions recur, subsequent surgical interventions become more challenging and carry higher risks, potentially resulting in total hysterectomy. Thus, early surgical intervention increases the difficulty of long-term management. Non-surgical therapies that preserve the intact cervix and avoid or delay cervical trauma are of significant importance for the long-term management of patients with cervical precancerous lesions.

Professor Chen Fei, Chief Physician of the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital, expressed her delight with the research findings, stating, "I am extremely pleased with the results of this study. Treating HSIL serves as the final barrier against cervical cancer. Previous international studies on HSIL have not been successful, but this study, utilizing a multicenter trial design and strict definition of efficacy endpoints, has achieved positive results, which is no easy feat. As a clinician, I have encountered many HSIL patients who desire to preserve their intact cervix while receiving treatment. The emergence of APL-1702 will fulfill the wishes of these patients, allowing them to avoid or delay cervical trauma to the maximum extent possible."

Professor Qiao Youlin, a member of the WHO Global Expert Group for Cervical Cancer Elimination and a professor at the School of Population Medicine and Public Health at the Chinese Academy of Medical Sciences/Peking Union Medical College, believes that in addition to vaccination and screening, treatment of cervical precancerous lesions is a crucial component of secondary prevention for cervical cancer. However, progress in the field of medication for cervical precancerous lesions has been relatively slow, with high barriers to overcome, and there are currently no approved treatment drugs worldwide. "It is gratifying to see the emergence of innovative products like APL-1702, which simultaneously possess clinical value in addressing the treatment gap, public health value in cervical cancer prevention and control, and social value in promoting fertility-friendly options. This breakthrough will safeguard women’s health and make a positive contribution to the acceleration of the 2030 global and Chinese action plans for cervical cancer elimination".

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702. The study not only demonstrates remarkable efficacy but also exhibits a favorable safety profile, offering a new powerful artillery for the national cervical cancer prevention and control system. We express our gratitude to all the patients, physicians, and researchers who participated in this study, as their support and dedication have been invaluable. We are actively preparing the new drug application for APL-1702 and plan to submit it in the second quarter of this year. Additionally, we are making significant progress in product development overseas, aiming to bring this innovative treatment to more patients as soon as possible."

References:

EUROGIN: Photodynamic therapy with APL-1702 for high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study (YHGT-CEV-1/APRICITY)
SGO: APL-1702 long-term efficacy and safety for cervical histologic high-grade squamous intraepithelial lesions (HSIL): results from a randomized phase Ⅲ global study
Gao Shujun, Sui Long. Standardized management and follow-up of high-grade squamous intraepithelial lesions of the cervix[J]. Chinese Journal of Practical Gynecology and Obstetrics. 2020,36(07):604-608.
About APL-1702(Cevira)

APL-1702(Cevira) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira in July 2019. Cevira is a registered trademark of Photocure ASA, based in Oslo, Norway.

WuXi AppTec Revenue Surpassed RMB40 Billion in 2023, and Adjusted Non-IFRS Net Profit Exceeded RMB10 Billion for the First Time

On March 18, 2024 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical and life sciences industry, reported its financial results for the year ending December 31, 2023 ("Reporting Period") (Press release, WuXi AppTec, MAR 18, 2024, View Source [SID1234641241]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Revenue grew 2.5% year-over-year to RMB40,341 million; excluding COVID-19 commercial projects, revenue grew by 25.6%.
Adjusted non-IFRS gross profit increased 11.2% year-over-year to RMB16,938 million. Adjusted non-IFRS gross profit margin improved 3.3pts to 42.0%. The Company continued to improve operating efficiency; adjusted non-IFRS net profit margin reached 26.9% due to FX impact and efficiency enhancement.
Net profit attributable to the owners of the Company[1] increased 9.0% year-over-year to RMB9,607 million; diluted EPS increased 14.9% year-over-year to RMB3.24. Adjusted non-IFRS net profit attributable to the owners of the Company increased 15.5% year-over-year to RMB10,855 million; adjusted diluted non-IFRS EPS increased by 15.7% year-over-year to RMB3.68.
Free cash flow continued to increase to RMB7,125 million. Due to FX impact and efficiency improvement, the Company’s operating cash flow grew by 23.6% year-over-year.
The Company’s Board of Directors has decided to maintain a 30% payout ratio, and distribute RMB ~9.8 cash dividend for every 10 shares (RMB 2.88 billion in total).
In 2023, we added over 1,200 new customers, and in total we served more than 6,000 active customers over the past 12 months. Demand from customers across regions globally continued to grow.
As of December 31, 2023, backlog grew 18% year-over-year excluding COVID-19 commercial projects, among which TIDES backlog grew significantly by 226% year-over-year.
Revenue from the top 20 global pharmaceutical companies maintained rapid growth and reached RMB16.11 billion in 2023, which grew 44% year-over-year excluding COVID-19 commercial projects.
The sustained and steady revenue growth is attributed to our unique fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. WuXi Chemistry’s D&M pipeline has maintained rapid growth, with a total of 1,255 new molecules added in 2023. By end of 2023, our D&M pipeline reached 3,201 molecules, among which 20 commercial and phase III projects were added during the year. Revenue from D&M services maintained strong growth. Excluding COVID-19 commercial projects, D&M services revenue grew by 55.1%.
As an enabler of innovation, a trusted partner and a contributor to the global pharmaceutical and life sciences industry, the Company is committed to environmental protection and sustainability. We committed to the Science Based Targets initiative (SBTi) in December 2023. We received an "AA" rating from MSCI for the third consecutive year, an "A-" rating in CDP Climate Change for the second consecutive year, and an "A-" rating in CDP Water Security for the first time. In addition, we were upgraded to the "Silver" medal by EcoVadis. Our outstanding ESG performances have also been widely acknowledged by major global ESG rating agencies, including S&P Global, Sustainalytics, and FTSE Russell.
[1] Net profit attributable to the owners of the Company is prepared according to Accounting Standard for Business Enterprises of PRC. Due to the different accounting treatment of long-term equity investments under IFRS, Net profit attributable to the owners of the Company under IFRS was RMB10,690 million.

[2] In 2022 and 2023, WuXi AppTec had a fully-diluted weighted average share count of 2,954,165,418 and 2,949,887,619 ordinary shares, respectively.

2024 Outlook

Despite uncertainties in the external environment, revenue is expected to reach RMB 38.3-40.5 billion in 2024, and maintain positive growth of 2.7-8.6% excluding COVID-19 commercial projects. We will continue to improve operating efficiency. Adjusted non-IFRS net profit margin (NPM) in 2024 is expected to remain at a similar level as last year, taking into consideration of new capacity ramp-up and FX impact. With improved asset utilization and operating efficiency, free cash flow is expected to remain positive and reach RMB 4-5 billion in 2024, which will continuously cover the cash dividends and investments in talents, while global capacity is expected to be expanded as planned (with capex of RMB ~5 billion).

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved an important milestone in 2023, with revenue surpassing RMB40 billion and adjusted non-IFRS net profit exceeding RMB10 billion for the first time. The Company’s unique CRDMO and CTDMO business models have enabled us to better meet the increasing quality demands from customers worldwide while continuing to drive business growth."

"As technology advancement and science innovations continue to emerge, global demand for life saving and innovative drugs continues to grow, along with customers’ demand for our enabling services. Nevertheless, the recent proposed legislation in the U.S. Congress would preemptively and unfairly designate our company without due process. As the proposed legislation remains subject to further review and changes, we continue to engage with relevant stakeholders to explore possible solutions and appeal for due process through a transparent consideration of the facts. WuXi AppTec has always been committed to ‘doing the right thing and doing it right.’ Our company has not been subject to any sanctions, and does not pose a national security risk to any country. Since its founding two decades ago, the value of WuXi AppTec has been to serve as an enabler to the pharmaceutical and life sciences industry. Today, we continue to do so as a trusted and valued service partner for our customers by constantly providing relevant capacity and capabilities required for new drug R&D and manufacturing."

"We are truly thankful for our customers’ long-term trust and support. We will further enhance our capacity and capabilities and continuously improve our operating efficiency, supporting our customers and partners in their endeavors to bring lifesaving medicines to patients around the world. Together, we can realize our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segments

WuXi Chemistry: Integrated CRDMO Business Model Drives Steady Growth, with Continued Expansion in New Modalities (WuXi TIDES)
Revenue from WuXi Chemistry grew 1.1% year-over-year to RMB 29.17 billion; excluding COVID-19 commercial projects, revenue grew strongly by 36.1%. Adjusted non-IFRS gross profit margin improved 4.0pts year-over-year to 45.1%, mainly due to FX impact, while efficiency continued to improve.
Drug discovery services ("R") continued to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 420,000 new compounds to customers, which grew 6% year-over-year. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our global customers, supporting the sustainable growth of our CRDMO business.
Development and manufacturing (D&M) services delivered strong growth.
i. In 2023, D&M services revenue declined 0.1% year-over-year to RMB21.62 billion; excluding COVID-19 commercial projects, D&M services revenue grew strongly by 55.1%.
ii. In 2023, we added 1,255 new molecules to our D&M pipeline. By end of 2023, our D&M pipeline reached 3,201 molecules, including 61 commercial projects, 66 in phase III, 326 in phase II and 2,748 in phase I and pre-clinical stages, among which 20 commercial and phase III projects were added during the year.
iii. We commenced operations at the new Taixing API manufacturing site in January 2024, preparing for future business growth.

Specifically, TIDES business (mainly oligo and peptides) continued to expand.
i. In 2023, TIDES revenue grew strongly by 64.4% year-over-year to RMB3.41 billion. By end of 2023, backlog of TIDES grew significantly by 226% year-over-year.
ii. In 2023, the number of TIDES D&M customers increased 36% year-over-year to 140, and the number of TIDES molecules increased 41% year-over-year to 267.
iii. We completed capacity expansion in Changzhou and Taixing. The expanded workshops commenced operations in January 2024, with the total reactor volume of solid phase peptide synthesizers increasing to 32,000L.

WuXi Testing: Drug Safety Evaluation Service & SMO Maintain Leadership Position and Drive Steady Growth
Revenue from WuXi Testing grew 14.4% year-over-year to RMB6.54 billion. Adjusted non-IFRS gross profit margin improved 1.9pts year-over-year to 38.6%, mainly due to FX impact, while efficiency continued to improve.
Revenue from lab testing services grew 15.3% year-over-year to RMB4.78 billion. Among which, revenue from drug safety evaluation services grew 27.3% year-over-year. We maintained our industry-leading position in the Asia-Pacific region. The 55,000m2 new facilities in Qidong and Suzhou ramped up smoothly. In 2023, additional 20,000m2 facilities were GLP-qualified.
Revenue from clinical CRO & SMO (Site Management Organization) grew 11.8% year-over-year to RMB1.76 billion.
i. SMO revenue grew 26.1% year-over-year, maintaining an industry leading position in China. In 2023, SMO supported 54 new drug approvals for customers.
ii. Clinical CRO enabled our customers to obtain 21 IND approvals and submit 5 NDA filings.

WuXi Biology: New Modalities Business Drives Growth; WuXi Biology Platform Continues to Generate Downstream Opportunities
Revenue from WuXi Biology grew 3.1% year-over-year to RMB2.55 billion. Adjusted non-IFRS gross profit margin improved 1.5pts year-over-year to 42.4%, thanks to FX impact.
The Company focused on improving capabilities related to new modalities. In 2023, WuXi Biology revenue from new modalities grew 26% year-over-year, contributing 27.5% of WuXi Biology revenue.
The comprehensive early discovery screening platform integrates multi-technologies (HTS, DEL, ASMS, FBDD, CADD etc.) and analysis capabilities of multi-dimensional databases, which can provide extensive and in-depth services to customers. In 2023, it continued to generate downstream opportunities and contributed more than 20% of the Company’s new customers.
WuXi ATU: CTDMO Business Model Drives Growth
Revenue from WuXi ATU grew 0.1% year-over-year to RMB1.31 billion. Adjusted non-IFRS gross profit margin declined 3.7pts year-over-year to (9.6)%, mainly due to the revenue decline from high-margin projects and under-utilization of capacity.
The Company focused on improving our CTDMO integrated enabling platform and strengthening capabilities and capacities. By end of 2023, we provided development, testing and manufacturing services to 64 projects, including 1 commercial project, 5 Phase III projects (1 project in BLA review stage, and 2 projects in BLA preparation stage), 9 Phase II projects and 49 pre-clinical and Phase I projects. In February 2024, the 2nd commercial product obtained approval.
In 2023, we supported a customer to file BLA for plasmid and Lenti-viral Vector (LVV) used in a CAR-T product and passed China’s Center for Food and Drug Inspection (CFDI) LVV on-site inspection. Our customer’s product obtained approval in November 2023. In addition, we supported a customer to complete the BLA filing for the world’s first innovative Tumor Infiltrating Lymphocyte (TIL)-based therapy, and our facilities in Philadelphia (U.S.) successfully passed FDA pre-license inspection (PLI). Our customer’s product obtained approval in February 2024. In June 2023, we signed an LVV manufacturing contract used in a commercial CAR-T product. With the process performance qualification now in progress, it is expected to start manufacturing in the first half of 2024. Moreover, we are preparing for the BLA filing for the manufacture of a blockbuster commercial CAR-T product, which is expected to complete process performance qualification in the first half of 2024 and is expected to file pre-approval submission (PAS) to the FDA in the second half of 2024.
WuXi DDSU: the First Year to Receive New Drug Application (NDA) Approval of New Drugs Developed for Customers; Breakthrough to Receive the First Royalty Income
Revenue from WuXi DDSU declined 25.1% year-over-year to RMB0.73 billion due to business transitions. Adjusted non-IFRS gross profit margin improved 6.3pts year-over-year to 36.5%, mainly due to favorable project mix.
In 2023, 3 new drugs developed for our customers obtained National Medical Products Administration (NMPA) approvals, including 2 for COVID-19 infection treatments and 1 for tumor treatment. We continued to receive the royalty income of the approved new drugs from customers. Moreover, 2 new drug candidates are in the NDA review stage.
In November 2023, for the first time, we supported a customer to reach a licensing agreement with one of the top 10 global pharmaceutical companies in the field of oncology.
In 2023, we supported customers to file INDs for 18 drug candidates and obtain 25 Clinical Trial Approvals (CTAs). Cumulatively, we have submitted 190 new chemical entity IND filings and obtained 169 CTAs for customers, among which 3 projects have obtained NDA approvals, 2 projects are in the NDA review stage, 4 projects are in Phase III, 32 projects are in Phase II, and 73 projects are in Phase I, covering multiple therapeutic areas.
This release provides a summary of the results and is not intended to be a comprehensive report. For additional information, please refer to the WuXi AppTec 2023 Annual Results Presentation and 2023 Annual Report disclosed on the Company’s official website, as well as the 2023 Annual Report and other relevant announcements published on the websites of the Shanghai Stock Exchange (www.sse.com.cn) and the Stock Exchange of Hong Kong (www.hkexnews.hk), and the designated media for dissemination of the relevant information. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net Profit Attributable to the Owners of the Company is prepared under Accounting Standard for Business Enterprises of PRC ("People’s Republic of China Financial Reporting Standards"), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared based on International Financial Reporting Standards (IFRS), in currency of RMB.

The 2023 Annual Report of the Company has been audited.

2023 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-IFRS
Gross Profit

Change

Adjusted non-IFRS
Gross Profit Margin

WuXi Chemistry

29,171.49

1.1 %

13,167.70

10.8 %

45.1 %

WuXi Testing

6,539.67

14.4 %

2,526.62

20.3 %

38.6 %

WuXi Biology

2,552.55

3.1 %

1,082.25

6.8 %

42.4 %

WuXi ATU

1,309.60

0.1 %

(125.11)

Note1

(9.6) %

WuXi DDSU

726.45

(25.1) %

265.33

(9.5) %

36.5 %

Others

41.05

22.1 %

20.99

33.6 %

51.1 %

Total

40,340.81

2.5 %

16,937.79

11.2 %

42.0 %

Notes: 1. Adjusted non-IFRS gross profit of WuXi ATU was RMB(125.11) million in 2023, compared to RMB(76.69) million in 2022, a decline of RMB48.42 million.
2. Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss[3] – Prepared under IFRS

RMB Million

Year Ended
December 31,
2023

Year Ended
December 31,
2022

Year-over-Year

Change

Revenue

40,340.8

39,354.8

2.5 %

Cost of services

(23,968.3)

(24,848.3)

(3.5) %

Gross profit

16,372.5

14,506.5

12.9 %

Other income

962.5

644.3

49.4 %

Other gains and losses

1,350.3

1,211.7

11.4 %

Impairment losses under expected credit
losses ("ECL") model, net of reversal

(240.9)

(117.3)

105.4 %

Impairment losses of non-financial assets

(67.4)

N/A

Impairment losses of goodwill

(49.6)

(131.3)

(62.2) %

Selling and marketing expenses

(701.0)

(731.6)

(4.2) %

Administrative expenses

(2,994.9)

(2,943.8)

1.7 %

Research and development expenses

(1,440.6)

(1,614.0)

(10.7) %

Operating Profit

13,190.7

10,824.6

21.9 %

Share of results of associates

(35.1)

(52.5)

(33.2) %

Share of results of joint ventures

(32.5)

6.3

N/A

Finance costs

(193.6)

(159.8)

21.1 %

Profit before tax

12,929.6

10,618.5

21.8 %

Income tax expense

(2,131.7)

(1,715.9)

24.2 %

Profit for the year

10,797.9

8,902.6

21.3 %

Profit for the year attributable to:

Owners of the Company

10,690.2

8,813.7

21.3 %

Non-controlling interests

107.7

88.9

21.2 %

10,797.9

8,902.6

21.3 %

Weighted average number of ordinary shares
for calculating EPS(express in shares)

– Basic

2,934,188,474

2,931,932,166

0.1 %

– Diluted

2,949,887,619

2,954,165,418

(0.1) %

Earnings per share attributable to ordinary
shareholders of the Company (expressed in
RMB per share)

– Basic

3.64

3.01

20.9 %

– Diluted

3.61

2.82

28.0 %

[3] If the sum of the data below is inconsistent with the total, it is caused by rounding

Consolidated Statement of Financial Position[4] – Prepared under IFRS

RMB Million

December 31,

December 31,

2023

2022

Non-current Assets

Property, plant and equipment

25,844.4

23,444.9

Right-of-use assets

2,348.3

1,857.5

Goodwill

1,820.9

1,822.1

Other intangible assets

906.7

926.3

Interests in associates

2,180.4

1,135.7

Interests in joint ventures

35.2

67.3

Deferred tax assets

366.7

492.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,626.0

8,954.3

Other non-current assets

105.8

1,054.9

Biological assets

1,012.5

938.0

43,246.9

40,693.1

Current Assets

Inventories

2,886.1

3,952.6

Contract costs

695.6

678.8

Biological assets

1,154.6

1,037.3

Amounts due from related parties

86.7

123.0

Trade and other receivables

9,372.7

7,590.4

Contract assets

1,234.4

1,048.2

Income tax recoverable

17.5

16.0

Financial assets at FVTPL

11.0

2.0

Derivative financial instruments

414.0

135.6

Other current assets

785.8

1,427.8

Pledged bank deposits

1.6

1.8

Term deposits with initial term of over three
months

3,761.4

Bank balances and cash

10,001.0

7,983.9

30,422.5

23,997.2

Total Assets

73,669.3

64,690.3

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[5] – Prepared under IFRS

RMB Million

December 31,

December 31,

2023

2022

Current Liabilities

Trade and other payables

7,333.5

7,253.4

Amounts due to related parties

11.5

14.5

Derivative financial instruments

501.9

115.4

Contract liabilities

1,955.4

2,496.6

Bank borrowings

3,721.6

3,874.1

Lease liabilities

240.5

205.3

Income tax payables

991.9

517.8

Other current liabilities

22.1

14,756.3

14,499.4

Non-current Liabilities

Bank borrowings

687.0

279.1

Deferred tax liabilities

530.1

440.5

Deferred income

1,079.9

910.9

Lease liabilities

1,098.6

983.8

Convertible bonds-debt component

502.0

Convertible bonds-embedded derivative
component

147.9

Other long-term liabilities

0.1

3,395.6

3,264.3

Total Liabilities

18,151.9

17,763.7

Net Assets

55,517.4

46,926.7

Capital and Reserves

Share capital

2,968.8

2,960.5

Reserves

52,153.6

43,629.4

Equity attributable to the owners of the
Company

55,122.5

46,590.0

Non-controlling interests

395.0

336.7

Total Equity

55,517.4

46,926.7

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[6]

RMB Million

Year Ended
December 31,
2023

Year Ended
December 31,
2022

Year-over-Year

Change

Net Profit Attributable to the Owners of the
Company under PRC

9,606.7

8,813.7

9.0 %

GAAP difference[7]

1,083.4

N/A

Net Profit Attributable to the Owners of the
Company under IFRS

10,690.2

8,813.7

21.3 %

Add:

Share-based compensation expenses

622.0

684.2

(9.1) %

Issuance expenses of convertible bonds

0.3

1.7

(81.4) %

Fair value gains from derivative
component of convertible bonds

(40.2)

(508.6)

(92.1) %

Foreign exchange related losses

294.4

136.1

116.3 %

Amortization of acquired intangible
assets from merge and acquisition

57.9

56.7

2.2 %

Non-financial assets impairment and
disposal losses

129.1

131.3

(1.7) %

Talent incentive and retention expenses
funded by cash donation from

shareholders

151.5

69.7

117.3 %

Non-IFRS Net Profit attributable to the
owners of the Company

11,905.2

9,384.7

26.9 %

Add:

Realized and unrealized (gains)/losses
from venture capital investments

(1,083.0)

20.8

N/A

Realized and unrealized share of
losses/(gains) from joint ventures

32.5

(6.3)

N/A

Adjusted non-IFRS net profit attributable to
the owners of the Company

10,854.6

9,399.3

15.5 %

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

[7] Due to the different accounting treatment of long-term equity investments under IFRS, it occurs GAAP difference of RMB1,083.4 million.