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诺诚健华:诺诚健华医药有限公司2025年度“提质增效重回报”行动方案的年度评估报告及2026年度“提质增效重回报”行动方案(英文版)

上海证券交易所 03-26 00:00 查看全文

InnoCare Pharma Limited

Annual Evaluation Report on 2025 “QualityImprovement Efficiency Enhancement and High

Return” Action Plan And

2026 “Quality Improvement Efficiency Enhancementand High Return” Action Plan

InnoCare Pharma Limited (“InnoCare” or the “Company”) actively and

consistently implements the investor-oriented development philosophy of a listed

company. On 28 March 2025 the Company issued the Annual Evaluation Report on

the 2024 “Quality Improvement Efficiency Enhancement and High Return” ActionPlan of InnoCare Pharma Limited and 2025 “Quality Improvement EfficiencyEnhancement and High Return” Action Plan and issued the “Half Year EvaluationReport on 2025 Quality Improvement Efficiency Enhancement and High ReturnAction Plan of InnoCare Pharma Limited” on 20 August 2025. In 2025 the Companyactively initiated and implemented relevant work based on the “Quality ImprovementEfficiency Enhancement and High Return” Action Plan and achieved satisfying

results regarding R&D innovation financial management corporate governance and

investor relations.In 2026 the Company will continue to adhere to the core value of “ScienceDrives Innovation for the Benefit of Patients”. Based on its own developmentalstrategies and operating conditions the Company has formulated the 2026 “QualityImprovement Efficiency Enhancement and High Return” Action Plan.The implementation details of 2025 “Quality Improvement EfficiencyEnhancement and High Return” Action Plan and major initiatives under the 2026

“Quality Improvement Efficiency Enhancement and High Return” Action Plan are as

follow:

I. Focus on the Areas of Oncology and Autoimmune Disease and Enhance Core

Competitiveness

The Company is an innovative biopharmaceutical enterprise driven by its

excellent core self-developed R&D capabilities. It focuses on the areas with extensive

unsatisfied clinical needs such as oncology and autoimmune disease and develops

best-in-class or first-in-class drugs with breakthrough potential. Under the leadership

of the management team with comprehensive experience in R&D manufacture and

commercialization the Company has established a fully integrated biopharmaceutical

platform that balances R&D quality and R&D pace covering product pipelines

targeting popular marketable molecules with an aim to develop and offer various

innovative drugs and treatments for our patients.In 2025 InnoCare successfully transformed from a single product company to a

company with multiple products covering various areas. The contribution fromhemato-oncology and solid tumor business continues to increase. Many R&D projects

have proceeded to late or registration development stage laying a solid foundation for

accelerating commercialization and long-term growth. Meanwhile the Company

completed two milestone business expansion transactions in 2025 significantly

enhancing the international deployment and value materialization of product pipelines

such as Orelabrutinib and ICP-B02.In terms of hemato-oncology the Company made significant progress in 2025.By advancing commercial execution late-stage clinical development and global

program expansion across three core therapies — orelabrutinib (BTK inhibitor)

tafasitamab (anti-CD19 monoclonal antibody) and mesutoclax (ICP-248 BCL-2

inhibitor) the Company has built a leading product portfolio. Orelabrutinib continued

to expand its indication coverage while advancing its global registration footprint

with approval granted for r/r MZL in Singapore and the New Drug Application (NDA)

submission for r/r MCL successfully completed in Australia further validating

orelabrutinib’s differentiated competitive advantages and reinforcing its position as a

leading global BTK inhibitor. Tafasitamab achieved an important commercialization

milestone in 2025 with regulatory approval granted in May and first prescriptions

issued in September establishing a solid foundation for full-year commercial

contribution in 2026. The next-generation BCL-2 inhibitor mesutoclax further

strengthened the long-term depth of the product portfolio with five ongoing clinical

studies including three registrational trials addressing multiple key areas of unmet

medical need. These include (1) a Phase III fixed-duration combination regimen with

orelabrutinib for 1L CLL/SLL; (2) a registrational study in MCL patients previously

treated with BTK inhibitors; and (3) a Phase III confirmatory registrational clinical

trial in r/r MCL. In parallel global clinical development of mesutoclax in acute

myeloid leukemia (AML) and myelodysplastic syndromes (MDS) is progressing

steadily in China US and other regions underscoring the program’s global potential.Together these three core therapies form the core of our hemato-oncology strategy of

the Company combining near-term commercial growth with a promising pipeline of

differentiated medium- to long-term development assets.In terms of autoimmune diseases leveraging our strengths in oral small-molecule

drug discovery the Company is advancing a robust portfolio of therapies targeting

both B-cell and T-cell pathways to address major autoimmune diseases. The clinical

development of orelabrutinib in the field of autoimmune diseases continues to

advance. Specifically the pivotal Phase III clinical trial for immune thrombocytopenia

(ITP) has completed patient enrollment and a New Drug Application is expected to

be submitted in the second quarter of 2026; positive Phase IIb results for systemic

lupus erythematosus (SLE) were disclosed at the end of 2025 and patient enrollment

for the Phase III clinical trial has commenced. Furthermore to accelerate the global

development of orelabrutinib in multiple sclerosis (MS) and unlock its international

clinical and commercial value the Company entered into an exclusive license

agreement with Zenas BioPharma Inc. (Zenas) in October 2025 to advance global

Phase III studies for primary progressive MS (PPMS) and secondary progressive MS

(SPMS). In terms of TYK2 target the Company has established a product pipeline

comprising multiple differentiated drug candidates and is continuously advancing

clinical development for various autoimmune disease indications by targeting T-cell-

mediated inflammatory mechanisms. Among these Soficitinib (ICP-332) one of the

Company’s key TYK2 programs is currently undergoing clinical trials for multiple

autoimmune indications. The Phase III clinical trial in moderate to severe atopic

dermatitis completed patient enrollment at the end of 2025 with primary efficacyanalysis expected in mid-2026. This is anticipated to be the first pivotal Phase III data

readout for this product. Concurrently the Company is advancing clinical

development across multiple indications including Phase II/III studies for vitiligo a

global Phase II study for prurigo nodularis Phase II/III studies for chronic

spontaneous urticaria and a Phase II study for moderate to severe plaque psoriasis. As

these studies progress clinical data from multiple indications are expected to be

generated throughout 2026 providing critical support for subsequent registrational

development. The Company’s another TYK2 allosteric inhibitor ICP-488 is also

actively advancing in clinical development. Currently the Phase III clinical trial of

ICP-488 in psoriasis indication completed patient enrollment in February 2026 with

primary efficacy endpoint analysis expected to be completed in 2026. Concurrently

the Company is advancing clinical development for new autoimmune disease

indications such as cutaneous lupus erythematosus (CLE). The Phase II clinical trial

for the CLE indication has been approved and patient enrollment is scheduled to

initiate. Additionally Phase II clinical IND for Sj?gren’s syndrome has been

submitted. Concurrently the Company continues to advance the next-generation of

innovative immunomodulatory mechanism programs into the clinical phase. These

include the ICP-538 (VAV1 molecular glues) which received IND approval in

February 2026 and initiated subject enrollment in March as well as ICP-054 (oral IL-

17 small molecule) for which global collaborations and clinical development in

China are underway with the IND application submitted in February 2026. In the

field of autoimmune diseases the Company has established an R&D framework led

by multiple Phase III clinical programs and driven by innovative mechanisms

building a differentiated pipeline of therapies for autoimmune diseases aimed at

addressing significant unmet clinical needs with first-in-class or best-in-class

therapies. These innovative drugs possess broad market potential worldwide.In terms of solid tumors the Company continues to advance the development of

innovative drugs through technological approaches such as targeted small-molecule

drugs and antibody-drug conjugates (ADCs). NMPA has approved Zurletrectinib

(ICP-723) to be used for treating NTRK fusion-positive solid tumors signifying the

Company’s first solid tumor treatment being approved for listing. The NDA for

pediatric indications will be submitted in 2026. In terms of innovative technology

platforms the Company has established an in-house antibody-drug conjugate (ADC)

platform and developed a proprietary linker-payload technology system. Leveraging

technical advantages such as stable antibody-drug conjugation technology

hydrophilic linker design and highly potent cytotoxic payloads this platform is

dedicated to enhancing the stability cell-killing activity and therapeutic window of

ADC drugs. ICP-B794 (a B7-H3-targeted ADC) is undergoing dose-escalation trials

with early clinical data demonstrating positive efficacy and safety profiles. Building

on this ADC platform the Company will continue to launch multiple differentiated

innovative drug candidates to further enrich its solid tumor product pipeline. The IND

for ICP-B208 (CDH17 targeted ADC) has been submitted in March 2026 once

approved it will rapidly progress to the clinical stage. Various ADC projects are also

undergoing development.II. Optimize Financial Management and Enhance Operating Efficiency

In 2025 the Company optimized the management system. On one hand it has

increased investment in sales and achieved an operating income of RMB2.375 billion

representing a year-on-year growth of 135.27%. On the other hand it enhancedstandardization and process of internal operation control with information technology

means strengthened the control and management over sales input and output thereby

enhancing operating efficiency and optimizing costs as a result the Company turned

around from loss to profit in 2025 and recorded a gain of RMB642 million.In 2025 the Company improved its operating efficiency by enhancing daily

operation management in the following aspects.In terms of financial management the Company’s strict budget management lays

the foundation for steady achievement of its strategic development goals and

reasonable allocation of resources. The Company used digital information technology

measures to enhance efficiency and further improve the financial reporting system

established a standard review procedure for its monthly quarterly and annual financial

reports. The Company timely monitored and focused on the discrepancies between

operating results and budgets integrated operation and financial management and

made adjustments to future business strategies based on such financial data. In

addition for financial management the internal system has been optimized

introducing multiple new functions such as report analytical function and data

synchronization and realizing visualized management reports of operating results

making the financial results more intuitive and improving the accuracy and efficiency

of business decision-making.In terms of operation the Company adopted the following initiatives to boost

operating efficiency:

(1) Improve capacity utilization rate and reduce unit production costs. In 2025

the Company fully utilized its existing capacity maintained efficient and orderly

equipment operation avoided idle capacity reduced the unit production cost of the

Company’s products increased the Company’s gross profit margin and enhanced its

core competitiveness.

(2) Improve sales quality accurately match the supply and sales chain and

increase turnover to reduce use of capital. The Company conducts monthly systematic

analysis on the Group’s operation assesses potential operational risks and

corresponding countermeasures. The supply chain department convenes monthly

cross-department sales and operation meetings to discuss and determine overall sales

forecasts order fulfillment arrangements production plans and corresponding

procurement needs of the Group.

(3) Prioritize expense control and management and improvement of cost

efficiency to promote the Company’s profitability. The Company reduced various

expenses in relation to operation through refined management initially introduced

digital tools to manage activities and expenses involved in sales R&D production

and management across all chains. This enabled a visualized management dashboard

that plainly lays out the Company’s expenses making it easier to promote refined cost

control in operations optimize the allocation of internal R&D resources diverse

investment in different sales regions and manage daily administrative expenses. This

improved operating efficiency and solidified the Company’s management philosophy

of “cost optimization and improve expense efficiency”.

(4) Strengthen distributor acceptance and distributor payments management. The

Company has enhanced its distributor acceptance mechanism emphasizing credit risk

assessment and review on the distributors improved its customer credit rating system

reinforced the sales team’s responsibility for payments collection and improved its

effective accounts receivable management mechanism to ensure credit risks are timely

updated and under control thereby enhancing capital turnover.In 2026 the Company will continue to optimize its operations and managementto enhance operating efficiency. It will integrate more refined management initiatives

into sales R&D production and management focusing on strengthening its core

business and improving operating efficiency and profitability. The Company will

improve operating indicators such as capacity utilization rate and net assets return. It

will adhere to the dynamic budget control and management mechanism to enhance

overall operational performance. It will continue to strengthen synergy between

inventory production procurement and accounts receivable and payable to improve

turnover of working capital. Through pipeline R&D overseas sales and sales channel

expansion the Company will optimize its industrial layout and increase sales revenue

and core competitiveness. Multiple measures will be taken to improve operational

quality and profitability accelerate the development of new productive forces and

enhance the Company’s investment value. The Company will introduce more AI

related tools to manage its daily operations and improve operating efficiency.III. Constant Improvement in Corporate Governance and Quality of Listed

Company

The Company is a red chip enterprise established in accordance with the Cayman

Company Law and is listed on the Hong Kong Stock Exchange and Shanghai Stock

Exchange. The current corporate governance institution of the Company is primarily

based on the relevant laws regulations and rules of the Company’s place of

registration and overseas listing region which forms a standardized corporate

governance structure. The Company’s shareholders meeting and the Board operate in

an independent and effective manner and fulfil its responsibilities in accordance with

relevant requirements including the Cayman Islands law the Rules Governing the

Listing of Securities on The Stock Exchange of Hong Kong Limited and the articles

of association of the Company. The specialized standing committees of the Company

include the Audit Committee Remuneration Committee and Nomination Committee

providing assistance to the Board in fulfilling its functions in the audit remuneration

and nomination aspects respectively. In addition the Company has appointed three

independent non-executive directors to participate in decision-making and supervision

enhancing the objectiveness and scientific rationale of the Board’s decisions.In 2025 the Company held 1 shareholder meeting 10 Board meetings and 12

specialized committee meetings in total. During the meetings relevant matters

including annual reports share incentives amendments to corporate system and

Board structure are resolved and passed. The Company strictly complies with relevant

laws regulations normative documents and its articles of association. It strictly

implements the shareholder meeting and Board systems with shareholders exercising

their rights in accordance with the law and directors exercising their powers and

diligently fulfilling their duties and obligations in accordance with relevant laws

regulations normative documents and the Company’s articles of association. In 2025

the Company systematically reviewed revised and formulated certain internal

governance systems revised 9 systems and formulated 2 new internal governance

systems in accordance with relevant requirements under related laws and regulations

including the “Securities Law of the People’s Republic of China” “Rules Governingthe Listing of Stocks on the STAR Market of the Shanghai Stock Exchange”“Guideline No. 1 for the Application of Self-regulatory Rules for Companies Listedon the STAR Market of the Shanghai Stock Exchange – Standardized Operation” and

the articles of association taking into account the actual status of the Company

effectively improving the Company’s governance level and standardized operationcapabilities.Since the establishment of the Company’s independent non-executive directors

system company secretary system and specialized committees of the Board daily

operations of each unit comply with the Company’s articles of association and

relevant regulations. Corporate governance and internal controls are sound and

effective in all material respects. The Company highly values the learning and

development of its “key minority” such as directors and senior management

encourages them to participate in trainings and exchange activities organized by the

Shanghai Stock Exchange the Beijing Securities Regulatory Commission the China

Association for Public Companies and the Beijing Association for Public Companies.In 2025 directors and senior management of the Company participated in a total of 35

sharing sessions in relation to integrity establishment sustainability and rule

interpretation etc. Meanwhile the Company reinforced the latest regulatory spirit and

compliance awareness among the “key minority” at a timely manner by ways of

distributing “STAR Market Regulatory Direct Train” and otherwise.In 2026 the Company will strive to further perfecting the corporate governance

structure as a legal corporation effectively enhancing the governance level of the

Company and establishing a more effective operation management and control

system to ensure the steady and orderly implementation of its business development

plans with an aim to safeguard shareholder interests enhance corporate value

optimize business strategies and policies and improve governance transparency and

accountability. At the same time the Company will collect and study the latest laws

and regulations and differences between the two capital markets actively encourage

the Board the management team and relevant departments to participate in training

sessions organized by regulatory agencies ongoing supervision institutions and

lawyers thereby strengthening the accountability of the “key minority” regarding

corporate governance ongoing supervision and information disclosure and optimize

the internal control management system to enhance the quality of the listed company.IV. Enhance the Quality of Information Disclosure and Strengthen

Communication with Investors

In order to effectively safeguard the legal rights and interests of investors the

Company has formulated the “Articles of Association” and “Rules on InformationDisclosure for Domestic Representatives” in accordance with applicable laws

regulations and normative documents. These systems could effectively ensure healthy

communication between the Company and investors enhance investors’

understanding towards the Company further improve the Company’s governance

level and safeguard the legal rights and interests of investors.In 2025 the Company held the 2024 Annual Results Briefing 2025 First Quarter

Results Briefing 2025 Interim Results Briefing and 2025 Third Quarter Results

Briefing at the Shanghai Stock Exchange Roadshow Center. Chairman and Chief

Executive Officer Independent non-execute director Chief Financial Officer and

Information Disclosure Officer all attended in person to fully communicate with

investors. The Company created and disseminated infographics or summaries of the

Company’s 2024 Annual 2025 First Quarter 2025 Interim and 2025 Third Quarter

Results through new media platforms and conducted investor communication

activities through various means including but not limited to company roadshows

organizing large-scale public exchange events participating in strategy meetings

organized by securities companies convening business progress communicationmeetings teleconferences Shanghai Stock Exchange e-interaction investor enquiry

hotlines and investor relations email to accurately disclose the long-term value and

operating conditions of the Company to investors. The Company was awarded the

“2025 Excellent Practice of the Board of Listed Company” and “2025 Best Practice ofthe Board Office of Listed Company” by the China Association for Public Companies.Meanwhile based on its industry characteristics the Company announced the clinical

progress of pipelines including Orelabrutinib ICP-332 ICP-488 and ICP-723 by

ways of voluntary information disclosure ensuring investors are updated with the

Company’s latest R&D development. In the Shanghai Stock Exchange 2024-2025

Evaluation of Information Disclosure the Company was rated as the highest level

Grade A.On 17 June 2025 the Company successfully organized the InnoCare open day

namely “Here Comes the Shareholders – Investors Visiting InnoCare” with nearly 70

guests comprising of institution investors analysts and mainstream financial media

representatives. In the event the guests visited the exhibition hall and R&D laboratory

of the Company and gained in-dept understanding of the Company’s strategies and

R&D development through the Q&A session. The event successfully enhanced the

interaction and transparency of shareholder communication thereby further solidified

the foundation for investor rights protection.In 2026 the Company will continue to enhance shareholder communication

convene results briefing timely after the announcement of annual report interim

report and third quarter report at the Shanghai Stock Exchange Roadshow Center and

organize interactive activities such as researcher day and key business progress

conference to enhance shareholder communication. The Company will arrange

dedicated personnel to handle and respond to the Company’s investor relation email

Shanghai Stock Exchange e-interaction and investor enquiry hotlines promptly

receive investor inquiries and listen to their opinions and demands maintain

communication and interaction with investors and safeguard the interests of small

and medium-sized investors. The Company will utilize new media forms such as

result infographics business summaries and videos to enhance the readability of

periodic reports and business updates announcements. The Company will continue to

improve the investor section on the Company’s official website and constantly upload

presentation materials to facilitate investors’ access to the Company’s information and

enhance their trust and support. Through professional and digital means the Company

will continuously improve communication efficiency.V. Enhance ESG Management Level and Materialize Sustainability

The Company deeply integrates ESG principles into its core corporate strategy

and deems it as a crucial cornerstone to drive the steady and healthy development and

set an industry benchmark.In 2025 the Company systematically carried out and continuously deepened the

identification assessment and dynamic optimization of dual-material matters further

enhancing the scientific and forward-looking nature of ESG management. In terms of

materiality assessment the Company identified 25 key issues based on regulatory

guidance and industry trends and determined priority of each issue through

stakeholder surveys. At the same time by interviewing key ESG-related departments

and analyzing historical data financial performance and future financial plans the

Company determined the financial importance of each issue. Based on the aboveassessment InnoCare formulated the 2025 dual- material matrix providing a clear

basis for improving the ESG information disclosure system reasonably allocating

short-term medium- term and long-term resources and formulating subsequent ESG

management plans. The Company actively responds to the “dual-carbon” strategy of

the PRC and fully implements the concept of green development. In 2025 the

Company constantly implemented energy conservation and emission reduction

measures and achieved environmental management goals ahead of schedule. The

Guangzhou subsidiaryadded an on-duty mode in the air conditioning system of the

plant used local reactive power compensation for new projects’ electricity supply and

install solar water heaters for the production of shower water. In 2025 the Company

saved approximately 610000 kWh of cold water electricity and approximately 881

tons of industrial steam in total. By optimizing the spray drying process in the

formulation workshop the idle spray time was shortened from 9 hours to 1 hour

saving 11760 kWh of electricity and reducing carbon emission by 11.55 tons.Meanwhile the Company deeply embedded the concept of energy conservation and

carbon reduction into its corporate culture through diversified online and offline

promotions and promoted the implementation through systematic and routine

management measures. By regularly conducting 5S inspections on all departments

the Company specified the requirements for workplace cleanliness and energy

conservation enabling employees to continuously reinforce energy-saving awareness

in daily work thereby stimulating the enthusiasm of all employees and jointly create a

low-carbon and green office and production environment.In 2026 the Company will continue to focus on responsibility systems including

environmental protection responsibility corporate governance responsibility product

and service responsibility talent development responsibility responsible operation

and social responsibility and charity. The Company will actively communicate with

all stakeholders constantly identify various ESG issues through dual materiality

analysis achieve environmental management targets and continuously improve its

ESG management level.In 2025 the Company implemented the “Quality Improvement EfficiencyEnhancement and High Return” Action Plan and promoted the high-quality

development of the Company. The Company adhered to the core business

continuously optimized its operations and management comprehensively improved

the operating quality strengthened investor relations management and maintenance

and effectively safeguarded the legal rights and interests of investors. The Company

continuously evaluates specific measures and further optimizes and formulates the

2026 “Quality Improvement Efficiency Enhancement and High Return” Action Plan

based on the 2025 action plan. Going forward the Company will focus on its core

business enhance the core competitiveness and risk management capabilities actively

reward investors through sound business management and standardized corporate

governance fulfill the responsibilities and obligations as a listed company and

promote the stable and healthy development of the capital market.The Company’s plans and development strategies referred in this report are

forward-looking statements that are not facts and do not constitute any substantive

commitment made by the Company to investors. Investors are advised to stay alert to

the relevant risks.Board of InnoCare Pharma Limited25 March 2026

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