WuXi AppTec Reports Record Results in 2022

On March 20, 2023 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, biotech and medical device industries to advance discoveries and deliver groundbreaking treatments to patients, reported its annual results for the year ending December 31, 2022 ("Reporting Period") (Press release, WuXi AppTec, MAR 20, 2023, View Source [SID1234629061]).

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This release provides a summary of the results and is not intended to be a comprehensive report. For additional information, please refer to the 2022 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.

All financial information disclosed in this press release is prepared based on International Financial Reporting Standards (IFRS), in currency of RMB.

The 2022 Annual Report of the Company has been audited.

[1] In 2021 and 2022, WuXi AppTec had a fully-diluted weighted average share count of 2,937,716,887 and 2,954,165,418 ordinary shares, respectively.

2022 Financial Highlights

In 2022, we achieved record revenue growth in a very challenging operating environment. Revenue grew 71.8% year-over-year to RMB39,355 million. This is primarily attributable to the Company’s continuing strong execution of our unique Contract Research, Development and Manufacturing Organization (CRDMO) business model to achieve synergy and strong growth:

WuXi Chemistry revenue grew 104.8% to RMB28,850 million and adjusted non-IFRS gross profit grew 106.6% to RMB11,882 million, with a gross profit margin of 41.2%.
WuXi Testing revenue grew 26.4% to RMB5,719 million and adjusted non-IFRS gross profit grew 37.3% to RMB2,101 million, with a gross profit margin of 36.7%.
WuXi Biology revenue grew 24.7% to RMB2,475 million and adjusted non-IFRS gross profit grew 22.5% to RMB1,013 million, with a gross profit margin of 40.9%.
WuXi ATU revenue grew 27.4% to RMB1,308 million and adjusted non-IFRS gross profit was RMB(77) million, with a gross profit margin of -5.9%
WuXi DDSU revenue declined 22.5% to RMB970 million and adjusted non-IFRS gross profit declined 48.7% to RMB293 million, with a gross profit margin of 30.2%.
Unit: RMB million

Segment

Revenue

Change

Adjusted
Non-IFRS
Gross Profit

Change

Adjusted
Non-IFRS
Gross Profit
Margin

WuXi Chemistry

28,849.73

104.8 %

11,881.96

106.6 %

41.2 %

WuXi Testing

5,718.65

26.4 %

2,100.73

37.3 %

36.7 %

WuXi Biology

2,475.15

24.7 %

1,013.14

22.5 %

40.9 %

WuXi ATU

1,308.00

27.4 %

(76.69)

Note1

(5.9) %

WuXi DDSU

969.63

(22.5) %

293.10

(48.7) %

30.2 %

Others

33.61

22.1 %

15.71

19.9 %

46.7 %

Total

39,354.78

71.8 %

15,227.95

75.0 %

38.7 %

Notes:
1. Adjusted Non-IFRS Gross Profit of WuXi ATU was RMB(76.69) million in 2022, compared to RMB11.43 million in 2021, a decrease of RMB88.11 million.
2. Any sum of the data above that is inconsistent with the total is due to rounding.

IFRS gross profit increased 75.5% year-over-year to RMB14,507 million. Gross profit margin was 36.9%.[2]
Adjusted non-IFRS gross profit increased 75.0% year-over-year to RMB15,228 million. Adjusted non-IFRS gross margin was 38.7%.
Net profit attributable to owners of the Company increased 72.9% year-over-year to RMB8,814 million.
Adjusted non-IFRS net profit attributable to owners of the Company increased 83.2% year-over-year to RMB9,399 million.
Diluted EPS increased 63.0% year-over-year to RMB2.82, while adjusted diluted non-IFRS EPS increased by 81.7% year-over-year to RMB3.18.
Company’s Board of Directors decided to distribute RMB 8.9266 cash dividend for every 10 shares (30% payout ratio, RMB2,644 million cash dividend in total).
[2] If prepared under Accounting Standard for Business Enterprises of PRC, the gross profit grew 76.6% year-over-year to RMB14,678 million. Gross profit margin was 37.3%.

2022 Business Operation Highlights

– We continued to expand our customer base globally. In 2022, demand for our services was very strong and we grew our customer base to more than 5,950 active accounts by adding over 1,400 new customers. We continued to optimize our cross-platform synergies to better serve our customers worldwide, strengthen our unique competitive advantage as a fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) and Contract Testing, Development and Manufacturing Organization (CTDMO) platform, and provide one-stop services for our clients from discovery to development and manufacturing. Revenue growth was demonstrated across our expanding global customer base:

Revenue from US-based customers grew 113% to RMB25,884 million; revenue from Europe-based customers grew 19% to RMB4,432 million; revenue from China-based customers grew 30% to RMB7,526 million; and revenue from other regions grew 23% to RMB1,512 million.
We remain focused on delivering high quality services with great efficiency to retain loyal customers for the long term. During the Reporting Period, revenue from existing clients grew 77% to RMB37,781 million and new clients contributed RMB1,573 million in revenue.
During the Reporting Period, revenue from the top 20 global pharmaceutical companies grew 174% to RMB18,421 million; revenue generated from all other customers grew 30% to RMB20,934 million.
Our unique positioning across the pharmaceutical development value chain drove our "follow-the-customer" and "follow-the-molecule" strategies and enhanced synergies across our business segments. Customers using services from multiple business units contributed RMB36,736 million in revenue, growing 87% year-over-year.
– WuXi Chemistry: CRDMO integrated business model drove revenue doubled

Revenue grew 104.8% to RMB28,850 million and adjusted non-IFRS gross profit grew 106.6% to RMB11,882 million, with a gross margin of 41.2%. Excluding COVID-19 commercial projects, WuXi Chemistry revenue grew strongly by 39.7%. Revenue from new modalities-related services (TIDES) grew 158.3% to RMB2,037 million.
Revenue from discovery chemistry services ("R") grew 31.3% to RMB7,213 million.
i. Our industry-leading small molecule drug discovery platform delivered more than 400,000 custom synthesized new compounds to our clients in the past twelve months. Through our small molecule discovery services, we enabled our customers to accelerate their research while generating opportunities for our downstream business units. As part of our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our global customers, supporting the rapid and sustainable growth of our CRDMO business.
ii. We continued executing our "long-tail" strategy. Demand from "long-tail" customers in small molecule and new modality-related discovery services continued to grow.

Revenue from development and manufacturing (D&M) services grew 151.8% to RMB21,637 million.
i. During the Reporting Period, we won 973 new molecules to our D&M pipeline, including 1 new molecule at the commercial stage. To date, our D&M pipeline consists of 2,341 molecules, including 50 in commercial stage, 57 in phase III, 293 in phase II and 1,941 in phase I and pre-clinical stages.
ii. D&M services for new modalities is gaining strong momentum. During the Reporting Period, the number of TIDES (mainly oligo and peptides) D&M clients increased 81% to 103 customers, and the number of TIDES molecules increased 91% to 189 molecules. Revenue from TIDES D&M business grew 337% to RMB1,578 million. Our TIDES business has a unique end to end CRDMO platform, enabling R&D and production of multiple complex conjugates. By Feb. 2023, we have in total 27 oligo production lines, over 10,000 liter peptide solid-phase synthesizers, and an R&D team of over 1,000 people. Our late-stage and commercial project delivery capabilities are favored by customers, supporting large scale production with industry leading speed. Furthermore, our integrated API plus DP platform have completed 16 CMC projects in 2022.

We continued our capacity expansion to meet customer demands. During the Reporting Period, we began operations in Changzhou Phase 3 facility, Changshu facility and our Wuhan campus, which further enhanced our global integrated CRDMO platform capabilities and capacities. We continued the design and construction of facilities in Changzhou and Wuxi city in China, Delaware in the U.S. and Tuas in Singapore, aiming to better serve our global customers’ future needs. Three sites located in Changzhou, Shanghai Waigaoqiao and Wuxi city were awarded "Silver" sustainability ratings by EcoVadis with excellent results, representing a leading position in the industry.
– WuXi Testing: strong growth driven by lab testing services

Revenue from WuXi Testing grew 26.4% to RMB5,719 million and adjusted non-IFRS gross profit grew 37.3% to RMB2,101 million, with a gross margin of 36.7%.
Revenue from lab testing services grew 36.1% year-over-year to RMB4,144 million.
i. The Company provides a full range of laboratory testing services for our customers, including drug metabolism and pharmacokinetics (DMPK), toxicology, and bioanalysis for drug development testing as well as medical device testing. We provide customers with high-quality services, realize "one report for global submission," and enable customers to save time, reduce costs and increase efficiency. By maintaining close collaborative relationships with our customers based on our "follow-the-molecule" and "follow-the-customer" strategies, existing customers account for over 60% of our customer base. We leveraged our integrated WuXi AppTec Investigational New Drug (WIND) program to generate preclinical data package and prepare global regulatory submissions of investigational new drug (IND), expediting the IND application process for many customers worldwide.
ii. Drug safety evaluation services achieved strong revenue growth of 46% year-over-year. We maintained our industry-leading position in Asia Pacific for drug safety evaluation services that meet global regulatory requirements.
iii. Our largely US-based medical device testing business has turned around and grew 33% year-over-year.
iv. On the capacity expansion side, 55,000 square meters laboratory are under construction in Suzhou and Qidong for 2023 delivery.

Our clinical CRO & SMO (Site Management Organization) reached a revenue of RMB1,575 million, representing year-over-year growth of 6.4%, due in part to the impacts of COVID-19 pandemic in many cities across China in 2022.
v. For clinical CRO, despite challenges in 2022, the Company provided services to approximately 200 projects, enabling our customers to obtain 15 IND approvals.
vi. For SMO, the Company maintained No.1 leadership position in China and continued to grow. Our SMO business maintained strong growth amid multiple rounds of lockdown in 2022, and continued to gain market share in multiple therapeutic areas (lung cancer, breast cancer, dermatology, cardiovascular disease, ophthalmology, rheumatology, and nervous system etc.). As of the end of 2022, our SMO business maintained approximately 4,700 staff across around 150 cities in China, providing services at more than 1,000 hospitals. During the Reporting Period, revenue from our SMO business grew 23.5% and backlog grew 35.6%. In 2022, our SMO business supported 35 new drug approvals for clients.
vii. Clinical CRO and SMO businesses leverage the strength of our Lab Testing platform to drive conversion. By leveraging our strong pre-clinical testing services, we have successfully converted 17 preclinical projects to clinical projects in 2022.

– WuXi Biology: demand for our broad biology services drove growth with strong contribution from new modalities related services

Revenue from WuXi Biology grew 24.7% to RMB2,475 million and adjusted non-IFRS gross profit grew 22.5% to RMB1,013 million, with a gross margin of 40.9%. Although revenue growth in the second quarter was temporarily impacted by the ongoing effects of the COVID-19 epidemic in Shanghai, business recovered in the second half due to the dedication of our employees.
The Company has one of the largest discovery biology enabling platform, with more than 3,000 experienced scientists who provide comprehensive biology services covering all major stages and therapeutic areas of drug discovery. The Company has established 3 centers of excellence for non-alcoholic steatohepatitis (NASH), anti-viral, neuroscience and aging.
Both our cancer discovery service and our rare and immune disease service continued to grow, providing customers with integrated high-quality services from target discovery to clinical biomarker detection.
The Company has a leading DNA Encoded Library (DEL) and compound generation platform with over 90 billion compounds, 6,000 unique proprietary scaffolds and 35,000 building blocks, providing these services for more than 1,500 customers. A customer advanced a project into clinical stage in 2022 based on the hits generated using our DEL screening technology. This was the first reported clinical candidate from our DEL hits, which is also an important validation of our platform.
The Company continues to build its biology capabilities for new modalities, including target protein degradation, nucleic acid-based and conjugated modalities, oncolytic virus, vector platform, and novel drug delivery vehicles. During the Reporting Period, WuXi Biology revenue from new modalities grew strongly by 90%. Its revenue contribution grew to 22.5% in 2022 from 14.6% in 2021, suggesting that new modalities-related biology services have become an increasingly important growth driver.
– WuXi ATU: CTDMO business model drove growth

Revenue from WuXi ATU grew 27.4% year over year to RMB1,308 million and adjusted non-IFRS gross profit was RMB-77 million, with a gross margin of -5.9%. Revenue from our Testing service grew 36%, and revenue from our Development service grew 43%. Gross profit declined largely due to under-utilized capacity at the newly built Shanghai Lingang site.
During the Reporting Period, the Company focused on improving our CTDMO integrated enabling platform and strengthened capabilities and capacities. We provided development and manufacturing services for 68 projects, including 50 pre-clinical and Phase I projects, 10 Phase II projects, and 8 Phase III projects (2 projects have filed BLA, and 2 projects are in BLA preparation stage). For the 2 projects filed for BLA, one is a TIL product for a US client, which is the world’s first innovative TIL-based therapy to be approved by FDA, and the other one is LVV used in a CAR-T product in China for a Chinese client. If they proceed as planned, we expect to have commercial stage projects in the second half of 2023.
Our unique CTDMO platform has driven us to capture significant business opportunities. In 2022, we signed a tech transfer agreement to manufacture a blockbuster commercial CAR-T product. In August, we announced Licensing Agreement with Janssen for TESSA.
– WuXi DDSU: business continues evolving in 2022 to better provide innovative drug discovery services to customers

Revenue from WuXi DDSU declined 22.5% to RMB970 million and adjusted non-IFRS gross profit declined 48.7% to RMB293 million, with a gross margin of 30.2%. DDSU’s revenue decline was mainly due to our business transition to focus on fewer but more innovative projects to meet customers’ demand for novel drug candidates. The future revenue growth will gradually come from royalty income.
In 2022, our success-based drug discovery service unit filed INDs for 28 drug candidates and obtained 34 Clinical Trial Approvals (CTAs). As of the end of 2022, we have cumulatively submitted 172 new chemical entity IND filings with the National Medical Products Administration (NMPA) and obtained 144 CTAs, with 1 project in NDA review stage, 7 projects in Phase III, 24 projects in Phase II, and 75 projects in Phase I. And by Mar 20, 2023, we have 2 projects in NDA review stage. We will begin receiving royalty income once our customers launch these products in the market. We expect to start receiving royalty income from approved products beginning 2023, which is estimated to grow with about 50% CAGR over the next 10 years as more and more products commercialized by DDSU customers.
Currently, we support 15 pre-clinical projects for customers in new modalities that include Peptide/Peptide-Drug-Conjugation (PDC), protein degraders and oligo. Several of these projects have filed IND in 2022, and multiple other projects are expected to file IND in early 2023.
– The unique CRDMO and CTDMO business model of the Company continues to successfully drive record high financial performance. Our business continued its healthy growth while large scale commercial production projects generated strong cash flow in 2022. Our operating cash flow in 2022 represented an accelerated year-over-year growth of 133.6%. Free cash flow turned positive in 2022.

2023 Outlook

On top of an exceptionally strong year of 2022, we expect revenue growth of 5-7% in 2023. Excluding COVID-19 commercial revenues, WuXi Chemistry expects to grow 36-38%, and TIDES (new modalities business in WuXi Chemistry) expects to grow as twice the speed of overall WuXi Chemistry. Other business segments (WuXi Testing, WuXi Biology, WuXi ATU) expect to grow 20-23%. WuXi DDSU will continue business transition, and expect to be down more than 20%.

The Company will focus on continuous improvement of operating efficiency in 2023 to drive profitability and free cash flow growth. Adjusted non-IFRS Gross Profit expects to increase 12-14% year-over-year, with further improved operating efficiency, which will be conducive to the growth of Adjusted non-IFRS Net Income. Free cash flow will continue to be positive in 2023, and expect to increase by 600-800%. Capex spending expects to be RMB 8-9 billion, resulting from better asset utilization and efficiency improvement, with no impact on long-term growth. We will continue to invest in new capabilities and capacities to better serve global customer demands, and promote future growth of the Company.

Our commitment to ESG

As an enabler of innovation, a trusted partner, and a contributor to the global healthcare industry, the Company is committed to environmental protection and sustainability, and to being a good global corporate citizenship.

Our outstanding ESG performance has been recognized by major global ESG rating agencies. In 2022, the Company received an "AA" rating from MSCI for a second consecutive year, and ranked in the top 2% for ESG ratings by Sustainalytics in the global pharmaceutical industry. Meanwhile, the Company was named to the 2022 Dow Jones Sustainability Index (both World and Emerging Markets) and was included in the S&P Global Sustainability Yearbook 2023 for the first time with an "Industry Mover" award. In addition, the Company received recognitions in various ESG ratings, such as a leadership level of "A-" in the CDP Climate Change rating. In EcoVadis assessment on suppliers’ responsibility, the Company was awarded a "Bronze" rating, and three sites in Changzhou, Shanghai Waigaoqiao and Wuxi city received "Silver" ratings.

In 2022, our carbon emission intensity, energy consumption intensity and water use intensity reduced by 17.3%, 19.0%, and 23.4%, respectively, compared to the baseline of 2021.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved record growth for 2022. Our revenue increased 71.8% year-over-year and our adjusted non-IFRS net profit attributable to owners of the company increased 83.2% year-over-year. Our third-quarter revenue reached the milestone of over RMB 10 Billion for the first time in our history. WuXi AppTec’s performance during 2022 demonstrated that the Company’s unique CRDMO and CTDMO business models allow us to better meet growing demands from customers worldwide and continue to drive rapid growth for the Company."

"In 2022, while COVID-19 continued to create uncertainty for many around the world, we effectively implemented our business continuity plan and leveraged our robust supply chain network to support our customers’ lifesaving work. We remain committed to prioritizing our customers’ needs. The Company will further enhance our capacity and capabilities and continuously improve our operating efficiency, to support our partners in their efforts to bring groundbreaking therapies to patients around the world. Driven by CRDMO and CTDMO business models, the Company is full of confidence to continue to grow and maintain our leading position as a global pharmaceutical R&D service platform."

"In 2022, we continued to integrate ESG into every aspect of our business operations and achieved excellent results. The Company remains steadfast in ‘doing the right thing and doing it right.’ We will keep prioritizing our ESG commitments while enabling our customers’ discovery, development and manufacturing of innovative medical solutions for those in need."

Consolidated Statement of Profit or Loss[3]

RMB Million

Year Ended
December 31,
2022

Year Ended
December 31,
2021

Year-over-
Year

Change

Revenue

39,354.8

22,902.4

71.8 %

Cost of services

(24,848.3)

(14,636.9)

69.8 %

Gross profit

14,506.5

8,265.5

75.5 %

Other income

644.3

468.6

37.5 %

Other gains and losses

1,211.7

1,453.6

(16.6) %

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

(117.3)

(31.6)

271.0 %

Impairment losses of goodwill, net of reversal

(131.3)

N/A

Selling and marketing expenses

(731.6)

(699.0)

4.7 %

Administrative expenses

(2,943.8)

(2,253.6)

30.6 %

Research and development expenses

(1,614.0)

(942.2)

71.3 %

Operating Profit

10,824.6

6,261.2

72.9 %

Share of results of associates

(52.5)

(92.2)

(43.0) %

Share of results of joint ventures

6.3

(25.1)

(124.9) %

Finance costs

(159.8)

(128.3)

24.5 %

Profit before tax

10,618.5

6,015.6

76.5 %

Income tax expense

(1,715.9)

(879.7)

95.1 %

Profit for the year

8,902.6

5,135.9

73.3 %

Profit for the year attributable to:

Owners of the Company

8,813.7

5,097.2

72.9 %

Non-controlling interests

88.9

38.8

129.2 %

8,902.6

5,135.9

73.3 %

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

– Basic

2,931,932,166

2,914,819,964

0.6 %

– Diluted

2,954,165,418

2,937,716,887

0.6 %

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

– Basic

3.01

1.75

72.0 %

– Diluted

2.82

1.73

63.0 %

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

Consolidated Statement of Financial Position[4]

RMB Million

December 31,

December 31,

2022

2021

Non-current Assets

Property, plant and equipment

23,444.9

15,848.7

Right-of-use assets

1,857.5

1,779.5

Goodwill

1,822.1

1,925.6

Other intangible assets

926.3

889.8

Interests in associates

1,135.7

619.4

Interests in joint ventures

67.3

58.9

Deferred tax assets

492.1

389.8

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

8,954.3

8,714.1

Other non-current assets

1,054.9

2,182.4

Biological assets

938.0

733.5

40,693.1

33,141.7

Current Assets

Inventories

3,952.6

4,554.6

Contract costs

678.8

594.9

Biological assets

1,037.3

755.5

Amounts due from related parties

123.0

343.3

Trade and other receivables

7,590.4

5,968.5

Contract assets

1,048.2

773.4

Income tax recoverable

16.0

0.2

Financial assets at FVTPL

2.0

527.3

Derivative financial instruments

135.6

229.1

Pledged bank deposits

1.8

63.4

Bank Balances and Cash

7,983.9

8,175.3

Other current assets

1,427.8

23,997.2

21,985.6

Total Assets

64,690.3

55,127.4

[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]

RMB Million

December 31,

2022

December 31,

2021

Current Liabilities

Trade and other payables

7,253.4

6,856.0

Amounts due to related parties

14.5

21.4

Derivative financial instruments

115.4

3.7

Contract liabilities

2,496.6

2,986.4

Borrowings

3,874.1

2,261.5

Income tax payables

517.8

459.3

Lease liabilities

205.3

220.2

Other current liabilities

22.1

176.2

14,499.4

12,984.6

Non-current Liabilities

Borrowings

279.1

Deferred tax liabilities

440.5

324.1

Deferred income

910.9

770.6

Lease liabilities

983.8

1,019.0

Convertible bonds-debt component

502.0

607.1

Convertible bonds-embedded derivative
component

147.9

657.3

Other long-term liabilities

0.1

7.2

3,264.3

3,385.3

Total Liabilities

17,763.7

16,369.9

Net Assets

46,926.7

38,757.5

Capital and Reserves

Share capital

2,960.5

2,955.8

Reserves

43,629.4

35,535.7

Equity attributable to owners of the Company

46,590.0

38,491.5

Non-controlling interests

336.7

266.0

Total Equity

46,926.7

38,757.5

[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,
2022

Year Ended
December 31,
2021

Year-over-
Year

Change

Profit Attributable to the owners of the Company

8,813.7

5,097.2

72.9 %

Add:

Share-based compensation expenses

684.2

539.9

26.7 %

Issuance expenses of convertible bonds

1.7

2.8

(39.3) %

Fair value (gains)/losses from derivative component of
convertible bonds

(508.6)

1,000.6

(150.8) %

Foreign exchange related losses

136.1

113.4

20.0 %

Amortization of intangible assets acquired in
business combinations

56.7

55.7

1.8 %

Goodwill impairment

131.3

N/A

Talent incentives and retention expenses
funded by cash donation from shareholders

69.7

N/A

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

9,384.7

6,809.6

37.8 %

Add:

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

20.8

(1,474.7)

(101.4) %

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

(6.3)

25.1

(125.1) %

Net disposal gain on sale of assets/business

(228.7)

(100.0) %

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

9,399.3

5,131.3

83.2 %

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

IceCure Medical to Report 2022 Full Year Financial & Operational Results on March 29, 2023

On March 20, 2023 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported that it will release its full year financial and operational results for the twelve months ended December 31, 2022, prior to the market open on Wednesday, March 29, 2023, and will host a conference call at 10:00 a.m. ET to discuss the results and corporate developments (Press release, IceCure Medical, MAR 20, 2023, View Source;operational-results-on-march-29-2023-301775982.html [SID1234629060]).

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Convergent Therapeutics to Announce Clinical Trial Updates on its Lead Candidate at the American Association for Cancer Research (AACR) Annual Meeting 2023

On March 20, 2023 Convergent Therapeutics Inc., a clinical-stage biotechnology company, reported the title of an upcoming clinical trial plenary oral presentation evaluating its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac), which will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando, April 14 – 19 (Press release, Convergent Therapeutics, MAR 20, 2023, View Source [SID1234629059]). The plenary talk entitled "Phase I dose-escalation study of fractionated dose 225Ac-J591 for metastatic castration resistant prostate cancer" will be presented by Dr. Jones T. Nauseef, Assistant Professor of Medicine in the Division of Hematology & Medical Oncology at Weill Cornell Medicine.

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Presentation Details:
Abstract Title: Phase I dose-escalation study of fractionated dose 225Ac-J591 for metastatic castration resistant prostate cancer
Date and Time: Monday April 17, 2023, from 11:45 AM – 12:00 PM
Location: W Hall A2-3 – Convention Center
Session Category: Clinical Trials Plenary Session
Session Title: Promising Novel Antitumor Strategies in Early Phase Clinical Trials
Presentation Number: CT014
Presenter: Dr. Jones T. Nauseef, Assistant Professor of Medicine in the Division of Hematology & Medical Oncology at Weill Cornell Medicine

Sirnaomics to Present Latest Developments in Polypeptide Nanoparticle Platform at the 4th Annual RNAi-Based Therapeutics Summit

On March 20, 2023 Sirnaomics Ltd. (the "Company", Stock Code: 2257.HK, and together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in the discovery and development of advanced RNAi therapeutics, reported that Dr. Patrick Lu, Chairman of the Board, Executive Director, President and Chief Executive Officer and Dr. Richard W. Welch, Vice President of Chemistry, Manufacturing, and Controls processes (CMC), will deliver keynote speeches during the 4th Annual RNAi-Based Therapeutic Summit (Press release, Sirnaomics, MAR 20, 2023, View Source [SID1234629058]). The conference, which will take place in Boston, MA, from March 21–23, 2023, aims to bring together prominent drug developers and academics, leading ultimately to the successfully delivery of siRNA into extrahepatic tissues.

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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

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Dr. Lu will present the Company’s proprietary Polypeptide Nanoparticle (PNP) technology for RNAi Cancer Therapeutics, with demonstration of dual-targeted drug design using either a local formulation or a systemic formulation for treatment of various types of cancers, such as non-melanoma skin cancers, cholangiocancinoma, pancreatic cancer and metastasized melanoma. The positive clinical readouts from multiple Phase II studies regarding treatments of Squamous Cell Carcinoma in situ and Basal Cell Carcinoma of STP705 allow the company moving forward into the late stage clinical development. Taking advantages of the targeting property of the PNP with siRNA drug payload, specifically against activated endothelium cells, the company has conducted a Phase I basket study for STP707 for treatment of multiple solid cancers. The initial dose escalation study has shown excellent safety profile with obvious therapeutic benefit to the patients.

Dr. Patrick Lu’s Presentation Details

Presentation Title: Key Clinical Study Readouts for Novel RNAi Cancer Therapeutics.

Time/Date: 9:00 am EST on Wednesday, March.22, 2023.

Presentation Details:

Advantage of polypeptide nanoparticle delivery for siRNA cancer therapeutics.
STP705 local formulation for treatment of non-melanoma skin cancers
STP707 systemic formulation for treatment of liver and pancreatic cancers
Dr. Richard W. Welch’s Presentation Details

Presentation Title: Developing Robust Processes to Enable Large-Scale Manufacturing to Scale Up for the Clinic – Lessons Learned in Developing and Scaling Novel Platforms

Time/Date: 3:30 pm EST on Thursday, March.23, 2023.

Presentation Details:

Overview of the early phase clinical development of one of the Company’s core platforms, including not only the challenges to the early phase and transfer from concept to clinic but indications about the challenges to commercialization as well
Exploring how the use of platform technologies can streamline development and achieve savings in time and resources.
An overview of how recent changes in the global supply chain and global regulatory and legal frameworks continue to present challenges in translating concepts into clinical material.
About the 4th RNAi-Based Therapeutics Summit

The 4th RNAi-Based Therapeutics Summit is returning to Boston to welcome more than 90 technical and strategic experts engaged in early discovery, preclinical, clinical, delivery, and manufacturing activities and to promote learning and networking with pioneers in the space to turbocharge more RNAi therapies into clinics and ultimately into extra-hepatic tissues. With a brand-new pre-conference focus day to evaluate next-generation delivery technologies, this summit offers the full end-to-end of RNAi drug development to support your own journey to realize the full potential of siRNA.

Innovent Announces Clinical Data of Multiple Trials Will be Presented at the AACR Annual Meeting 2023

On March 20, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that clinical data from multiple trials in relation to TYVYT (sintilimab injection), Pemazyre (pemigatinib) and IBI351 (KRASG12C inhibitor) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, April 14 – 19, 2023 (Press release, Innovent Biologics, MAR 20, 2023, View Source [SID1234629057]). A brief summary of the presentations is as follows:

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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

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Topic: Phase I study of IBI351 (GFH925) monotherapy in patients with advanced solid tumors: Updated results of the phase I study
Presentation Type: Oral Presentation
Abstract Number: CT030
Main Researcher: Prof. Qing Zhou, Prof. Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital
Presentation Date/Time: Monday Apr 17, 2023 2:30 PM – 4:30 PM

Topic: Updated overall survival outcomes from a randomized, double-blind phase III study of sintilimab versus placebo in combination with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma (ORIENT-15)
Presentation Type: Poster
Poster Number: CT075
Main Researchers: Prof. Shen Lin, Peking University Cancer Hospital and Institute
Presentation Date/Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM ET

Topic: First-line treatment with sintilimab (sin) vs placebo in combination with chemotherapy (chemo) in patients (pts) with unresectable gastric or gastroesophageal junction (G/GEJ) cancer: Final overall survival (OS) results from the randomized, phase III ORIENT-16 trial
Presentation Type: Poster
Poster Number: CT078
Main Researcher: Prof. Jianming Xu, the Fifth Medical Center of People’s Liberation Army General Hospital
Presentation Date/Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM ET

Topic: Efficacy and safety of sintilimab (anti-PD-1 mAb) for advanced cervical cancer: Results from a Phase II trial
Presentation Type: Poster
Poster Number: CT079
Main Researcher: Prof. Qinglei Gao, Prof. Ding Ma (academician), Tongji Hopstial, Tongji Medical College, Huazhong University of Science and Technology
Presentation Date/Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM ET

Topic: Pemigatinib in Chinese patients with advanced/metastatic or surgically unresectable cholangiocarcinoma Including FGFR2 fusion or rearrangement: Updated overall survival from an open-label, single-arm, multicenter Phase II study
Presentation Type: Poster
Poster Number: CT153
Main Researchers: Prof. Xiaoyong Huang, Prof. Guo-Ming Shi, Prof. Jian Zhou, Zhongshan Hospital, Fudan University, Shanghai, China
Presentation Date/Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells[i]. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for six indications. Approved indications of sintilimab include:

For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
In combination with bevacizumab for the first-line treatment of unresectable locally advanced or metastatic hepatocellular carcinoma;
In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Innovent currently has the regulatory submission for sintilimab in combination with bevacizumab biosimilar and chemotherapy for EGFR-TKI failed EGFR-mutated non-squamous NSCLC under review in the China’s NMPA.

Additionally, two clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan.

In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.

In June 2021, Taiwan Food and Drug Administration (TFDA) approved Pemazyre for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.

In January 2022, Hong Kong Department of Health (DH) approved Pemazyre for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

In April 2022, the National Medical Products Administration (NMPA) of China approved Pemazyre for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2(FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.

Pemazyre is a trademark of Incyte Corporation.

About IBI351/GFH925 (KRASG12C Inhibitor)

Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRASG12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of IBI351 towards G12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest. In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.