Lipomed Pharmaceuticals Soars Over 100% on HKEX Debut; CSPC Inks $1.77B siRNA Deal with AstraZeneca

Jul 09, 2026 13:27 CST Updated 13:27

Alebund

Developer of Kidney and Chronic Disease Treatment Products

CSPC

Innovative Drug Research and Development, Manufacturer

Zymeworks

Protein Therapy Developer

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

Brii Biosciences

Innovative Drug Research and Development Service Provider

Biokin

Pharmaceutical R&D Developer

Sirius Therapeutics

Oligonucleotide Drug Developer

Global Biopharmaceutical Industry Trends

Capital Markets

Wave of IPOs and M&A Deals: Alebund Lists on HKEX, Raising HK$1.283 Billion with Cornerstone Investors Including GIC and Tencent; Shares Surge 100% at Open. Shenji Pharmaceuticals, Fosun Antronic (post-last-round valuation: RMB 7.97 billion), ImmuneOnco (post-last-round valuation: RMB 3.8 billion), and Sinocanovo (planned raise: RMB 2.94 billion) Intensify IPO Filings or Pass Listing Hearings. Lintaikr Biotech Completes Series A and A+ Financing to Deepen lncRNA Nucleic Acid Delivery; Jiajin Biotech Secures Investment from YuanSheng Venture Capital and Lilly Asia Ventures to Advance Extrahepatic Targeted AOCs; Ruijian Medicine Raises RMB 260 Million in Series C+ Financing to Focus on CNS Stem Cell Regeneration; Lingtai Tianrun Completes Nearly RMB 100 Million in Pre-A+ Financing to Advance Clinical Development of the World’s First IBD ADC; Etopha Medicine Completes Series B2 Financing to Focus on LLPS Technology Platform. Zymeworks Acquires Theravance for $929 Million, Gaining COPD Drug YUPELRI; Ipsen Acquires Kartos for Up to $1.75 Billion, Securing MDM2 Inhibitor Navtemadlin. JiTai Tech’s $1.6 Billion TCE License Deal with Deerfield Sets New Record for Single Preclinical Transaction in China; CSPC Licenses siRNA to AstraZeneca for Up to $1.77 Billion; Insilico Medicine Partners with Takeda on $600 Million AI-Driven Drug Discovery Collaboration; Abbisko Therapeutics Enters Strategic Partnership with AstraZeneca to Advance PD-L1 Combined with Osimertinib; Junshi Biosciences Licenses IL-17A Monoclonal Antibody to Fosun Wanbang for Up to RMB 1.34 Billion; Innovent Biologics Receives Verzenio from Lilly.^®Exclusive Rights in Mainland China: Bristol Myers Squibb Initiates Phase III Trial of Iza-Bren for First-Line NSCLC, Triggering a $250 Million Milestone Payment; Nonna Biotech Partners with Lonza on Blood-Brain Barrier Penetration Technology; Parent Company of BioThera Solutions Raises $250 Million in Financing.

Clinical Progress

Positive developments frequently reported in oncology, rare diseases, and infectious diseases: AbbVie’s epcoritamab met the primary endpoint in a Phase III trial for diffuse large B-cell lymphoma (DLBCL), significantly prolonging progression-free survival (PFS) and reducing the risks of disease progression and death by 60% and 56%, respectively; BeOne’s zanubrutinib combined with rituximab met the primary PFS endpoint in a Phase III trial for mantle cell lymphoma, reducing the risk by 43%; Sanofi’s avalglucosidase alfa achieved both the primary and all secondary endpoints in a Phase III trial for treatment-naïve infantile Pompe disease; Roche’s divarasib significantly improved both PFS and overall survival (OS) in a Phase III trial for KRAS G12C-mutated non-small cell lung cancer (NSCLC); Brii Biosciences’ BRII-179 achieved HBsAg clearance rates of 42.9% and 40.0% in a Phase IIb trial for chronic hepatitis B, demonstrating excellent efficacy even in populations with high treatment difficulty; Insilico Medicine’s rentosertib initiated its first Phase III trial for idiopathic pulmonary fibrosis; Biokin’s BL-M07D1 commenced a head-to-head Phase II trial against DS-8201 for HR+/HER2-low breast cancer as part of its registration strategy; and Sirius Therapeutics’ SRSD384 completed the first dosing in a Phase I/IIa trial for overweight and obesity.

Industry Strategic Adjustments

Accelerated Capitalization in Pharmaceutical Companies and Continuous Upgrading of R&D Models: Multiple companies are increasing investments in core platforms such as lncRNA nucleic acid drugs, siRNA extrahepatic targeted delivery, AI-driven drug discovery, multispecific TCEs, and ADCs. Domestic pharmaceutical companies are intensively advancing IPOs on the Hong Kong Stock Exchange and the STAR Market, as well as overseas licensing of their pipelines. Multinational pharmaceutical companies are securing domestic innovative assets through large-scale acquisitions and early-stage R&D collaborations. AI-driven new drug discovery, modular nucleic acid delivery, and gene-targeting technologies have become the core directions for industry upgrading. A normalized industrial cycle has formed, comprising platform licensing, major M&A transactions, primary market financing, and IPO filings, while the internationalization process of innovative drugs continues to accelerate.

Global Biopharmaceutical Industry

Major Events

Global Innovative Drugs

Key Clinical Developments/Results

Global Innovative Drugs

Key Investment, Financing, and Transaction Events

# Weekly Summary

From June 29 to July 5, 2026, biomedical financing, investment, and collaborative transactions remained highly active. Alebund (09637.HK) listed on the Hong Kong Stock Exchange, raising approximately HK$1.283 billion, with its share price surging over 100% on the first day of trading. Zymeworks acquired Theravance Biopharma for $929 million, gaining rights to the COPD drug YUPELRI. Ipsen acquired Kartos Therapeutics for up to $1.75 billion, securing the MDM2 inhibitor navtemadlin. DtT Medicine licensed a tri-specific TCE to Boulevard Bio for $1.6 billion, setting a new record for the largest single overseas preclinical TCE licensing deal from China. CSPC licensed its siRNA drug to AstraZeneca, with total potential payments reaching up to $1.77 billion. Insilico Medicine entered into a $600 million AI R&D collaboration with Takeda Pharmaceutical. Junshi Biosciences licensed the Greater China rights for its IL-17A monoclonal antibody JS005 to Fosun Wanbang for RMB 1.34 billion. Innovent Biologics obtained exclusive commercialization rights in mainland China for Eli Lilly’s CDK4/6 inhibitor Verzenio. Akeso Biopharma partnered with AstraZeneca to advance the combination of its PD-L1 inhibitor with osimertinib for the treatment of NSCLC. Bristol Myers Squibb (BMS) initiated a Phase III clinical trial of Iza-Bren as a first-line treatment for EGFR-mutated NSCLC, triggering a $250 million milestone payment. Lintek Biologics consecutively completed Series A and Series A+ financing rounds, focusing on overcoming extrahepatic delivery challenges for lncRNA nucleic acid drugs. Lingtai Tianrun completed a Pre-A+ financing round of nearly RMB 100 million, advancing the world’s first IBD-targeting ADC into clinical trials. Jiajin Biotechnology completed a new round of financing with participation from Lilly Asia Ventures and others, focusing on liver-targeted Antibody-Oligonucleotide Conjugates (AOCs). Ruijian Medicine completed a RMB 260 million Series C+ financing round, focusing on central nervous system stem cell regeneration. Etop Medicine completed its Series B2 financing, led by Guangzhou Industrial Investment Holdings, focusing on small molecule drugs targeting liquid-liquid phase separation (LLPS). Nona Biosciences partnered with Lonza to develop blood-brain barrier penetration technologies. Fosun Antrikin filed for an IPO on the Hong Kong Stock Exchange, following a post-money valuation of RMB 7.968 billion in the previous round. ImmuneOnco filed for an IPO on the STAR Market, with a post-money valuation of RMB 3.8 billion in the previous round. Sinocelltech’s IPO application was approved by the STAR Market, with plans to raise RMB 2.94 billion. Shenji Pharmaceuticals pursued an IPO in Hong Kong; the company was restructured after BridgeBio Capital acquired assets from UCB. Nuvation Bio raised $250 million to develop DDCs and small molecules.

Investment and Financing

Jiajin Biosciences — New Round of Financing

Update: Recently, Jiajin Biopharmaceuticals (Shanghai) Co., Ltd. completed a new round of financing, with joint investment from Kangjun Capital, Yuansheng Venture Capital, Qingsong Capital, C&D Emerging Investment, and Lilly Asia Ventures.

Significance: The company is the first innovative biotech enterprise in China to focus on the original research and development of extrahepatic targeted small nucleic acid conjugates (XOC/AOC). Its core product, CGB1001, has completed preclinical pharmacology and toxicology studies and received FDA Orphan Drug Designation in October 2025. The company plans to initiate dual IND filings in China and the United States during 2026–2027, making it the only DM1-targeted AOC drug in China to enter the late preclinical/early clinical stage.

Lingtai Tianrun — Nearly RMB 100 Million in Pre-A+ Round Financing

Update: On June 23, Lingtai Tianrun officially announced the completion of its Pre-A+ financing round, raising nearly RMB 100 million. This round took place just five months after its previous Pre-A financing, and was led by Boyuan Capital, with continued increased investment from early shareholder Xingze Capital.

Significance: The funding will comprehensively support the advancement of global multi-center clinical trials, while simultaneously iterating two proprietary ADC technology platforms and expanding the differentiated innovative pipeline in the fields of autoimmunity and oncology. The company’s first-in-class IBD ADC has entered clinical trials, positioning it as a rare emerging biotech in China that deeply cultivates both the autoimmune and oncology ADC sectors.

Ruijian Pharma — RMB 260 Million Series C+ Financing

News: Recently, Ruijian Pharma announced the completion of its C+ round financing amounting to RMB 260 million. The round was led by Chengdu Science and Technology Innovation Investment Group, with joint investments from China Securities Capital, Wuxi Venture Capital Group, Dingtai Star, Xinjiye, and Hony Capital. Existing shareholders, including Yuanxi Haihe and GSR United Runpu Yuanfeng, continued to increase their investments.

Significance: The company focuses on developing in vitro regeneration systems for central nervous system stem cells. Leveraging its proprietary library of inducing small molecules and real-time live-cell reporting platform, it has established multiple cell therapy pipelines based on chemically induced adult cell regeneration, covering various fields including neurodegenerative diseases, metabolic disorders, and rare diseases.

Yituo Pharma — Series B2 Financing

News: Yituo Pharmaceutical Group officially announced the completion of its Series B2 equity financing, exclusively led by Guangzhou Bio-medicine and Health Industry Investment Co., Ltd.

Significance: Leveraging protein liquid-liquid phase separation (LLPS) as its core technology platform, the company is engaged in the global innovative development of small-molecule drugs across various disease and health sectors, including anti-aging. The company’s lead candidate, ETD-001, a first-in-class targeted therapy for pathological scarring, has entered clinical trials, with multiple pipelines focused on skin anti-aging and general health poised to enter clinical studies in succession.

Nuvation Bio (NUVB) — $250 Million Convertible Senior Notes

Update: On June 25, Nuvation Bio announced a proposed underwritten offering of convertible senior notes due 2032, with an aggregate principal amount of $250 million, and plans to grant the underwriters an over-allotment option to purchase up to an additional $30 million.

Significance: Nuvation Bio is a global oncology pharmaceutical company, with core assets including the next-generation ROS1 inhibitor taletrectinib (brand name IBTROZI®), the blood-brain barrier-penetrating IDH1 inhibitor safusidenib, and a novel drug-drug conjugate (DDC) development pipeline.

Shenji Pharmaceuticals — Hong Kong IPO

News: In June 2026, Apex Healthcare submitted its prospectus to the Hong Kong Stock Exchange. The company was restructured and established in June 2024 after funds under Qiaokang Capital and ATIC, a subsidiary of the United Arab Emirates' sovereign wealth fund, acquired UCB's commercial operating assets in China from the Belgian global pharmaceutical company UCB.

Significance: Attempting to establish a new valuation benchmark in the Hong Kong stock market, with annual sales of a single product reaching RMB 950 million.

Fosun Antong — Filing for Hong Kong IPO

Update: On June 26, Fosun Antin’s application for an initial public offering (IPO) on the Hong Kong Stock Exchange was accepted. The company has been deeply engaged in the preventive vaccine industry for over two decades, with revenues of RMB 325 million, RMB 81.29 million, and RMB 526 million in 2023, 2024, and 2025, respectively. In June 2026, it completed a financing round of RMB 968 million, resulting in a pre-money valuation of RMB 7 billion and a post-money valuation of RMB 7.968 billion.

Significance: Centered on innovative vaccines, the 13-valent pneumococcal conjugate vaccine is in Phase III clinical trials, and the 24-valent pneumococcal conjugate vaccine is in Phase I clinical trials. The company has established a solid position in the industry by leveraging its technologies in protein vaccines, polysaccharide/conjugate vaccines, and attenuated/inactivated vaccines.

Xinnuowei — IPO Application Approved by the STAR Market

Update: On June 26, Xinonwei’s IPO application for the STAR Market was approved by the Listing Committee. The company applied under the fifth set of listing criteria of the STAR Market, with Guotai Haitong serving as the sponsor, and plans to raise RMB 2.94 billion.

Significance: The New Drug Application (NDA) for the core product, Imipenem-Cilastatin for Injection (XNW4107), has been accepted. It is one of the few drugs in China with demonstrated antibacterial activity against all three major carbapenem-resistant Gram-negative bacteria (CRAB, CRPA, and CRE). This enables broader coverage of resistant strains in empirical initial therapy, thereby improving treatment success rates.

ImmunoGen — Files for STAR Market IPO

Update: On June 30, ImmuneOnco’s IPO application for listing on the STAR Market was accepted. The company plans to issue no more than 10 million shares and raise RMB 2.5 billion. From December 2024 to March 2025, it completed a Series G financing round of RMB 396.62 million, with a pre-money valuation of RMB 3.4 billion and a post-money valuation of RMB 3.79662 billion.

Significance: Focusing on innovative CAR-T cell therapies, the core product IM19 has submitted a marketing application for third-line treatment of relapsed/refractory non-Hodgkin lymphoma (r/r NHL). The company is also developing autologous CAR-T, universal CAR-T, and in vivo CAR-T therapies, with IM96 indicated for colorectal cancer and ZM001 for systemic lupus erythematosus.

Transaction Authorization

Alebund (09637.HK) — Listed on the Main Board of the Hong Kong Stock Exchange

Update: On June 29, 2026, Alebund was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with a global offering of a total of 56,755,400 H shares at an offer price of HK$22.60 per share. The total amount raised globally was approximately HK$1.283 billion, with net proceeds of approximately HK$1.180 billion (Surge of 103%! The First "HK-Listed Innovative Nephrology Drug" Stock Is Born! Alebund Lists on the HKEX）. Cornerstone investors include GIC, Loomis Sayles, RTW Fund, Symbiosis, Tencent (00700.HK), Cormorant, DAMSIMF, GF Fund Management, Harvest Fund Management (HK), E Fund Management, and LVC.

Significance: The vast majority of the funds raised will be allocated to global multi-regional clinical research and development of core nephrology pipeline candidates, including AP301, AP306, and AP303. The remaining funds will be used for the construction of the active pharmaceutical ingredient (API) production base in Yangzhou, the establishment of a commercialization team, and supplementary working capital for the Group’s daily operations. On its first day of trading, the stock opened 85.84% higher, closing at HK$42.00 per share, with a market capitalization of HK$14.274 billion.

Zymeworks — Acquires Theravance Biopharma for $929 Million

News: On June 29, Zymeworks (NASDAQ: ZYME) announced that it had entered into a definitive agreement to acquire Theravance Biopharma (NASDAQ: TBPH) for $17.00 per share in cash, representing a total transaction value of approximately $929 million.

Significance: This acquisition adds YUPELRI® to Zymeworks’ portfolio, the first and only nebulized long-acting muscarinic antagonist (LAMA) for maintenance treatment of chronic obstructive pulmonary disease (COPD), aimed at improving outcomes in patients with severe disease.

Ipsen — Up to $1.75 Billion Acquisition of Kartos Therapeutics

Update: On June 29, French pharmaceutical giant Ipsen officially announced the full acquisition of U.S. biotechnology company Kartos Therapeutics for up to $1.75 billion, comprising an upfront payment of $450 million in cash plus milestone payments of up to $1.3 billion. The transaction is expected to be completed by the end of the third quarter of 2026.

Significance: The acquisition secures the core asset navtemadlin (KRT-232), a selective oral MDM2 inhibitor currently in Phase III clinical development for the treatment of myelofibrosis. This transaction sets a new record for M&A deal value in the hematologic oncology sector in recent times.

Jitai Technology (7666.HK) — $1.6 Billion Licensing Deal for Trispecific TCE

News: On June 30, Mintai Therapeutics entered into a global exclusive licensing agreement with Boulevard Bio, a U.S. biotechnology company backed by Deerfield, granting it the rights to develop, manufacture, and commercialize MTS-128, a tri-specific T cell engager (TCE) program independently developed by Mintai Therapeutics, worldwide. Mintai Therapeutics will receive an upfront payment of $20 million, up to $1.6 billion in milestone payments, and sales royalties.

Significance: This transaction has set a new record for the largest single overseas licensing deal in the amount of payment for a preclinical TCE project by a Chinese pharmaceutical company. It also marks an important milestone in the internationalization of China's AI-driven drug delivery innovations, signifying that AI-powered drug delivery platforms are transitioning from the technology validation stage to the realization of global commercial value.

Junshi Biosciences (688180.SH/01877.HK) — RMB 1.34 billion licensing deal for Greater China rights to IL-17A monoclonal antibody

Updates: On June 30, Junshi Biosciences and Fosun Wanbang, a wholly-owned subsidiary of Fosun Pharma, signed an Authorization Agreement to out-license all rights for the development, registration, manufacturing, and commercialization of its self-developed anti-IL-17A monoclonal antibody, socazolimab (JS005), in the Greater China region.

Significance: Leveraging Fosun’s commercialization capabilities in the autoimmune field to accelerate product launch, with total potential revenue reaching up to RMB 1.34 billion (tax inclusive). JS005 has been granted exclusive rights for development, registration, and commercialization in the Greater China region, along with a joint exclusive license for manufacturing.

Innovent Biologics — Secures Exclusive Commercialization Rights in Mainland China for Eli Lilly’s CDK4/6 Inhibitor Verzenio

Update: On June 30, Innovent Biologics and Eli Lilly reached a cooperation agreement regarding the rights for the CDK4/6 inhibitor Verzenio® (abemaciclib tablets) in mainland China. Innovent Biologics obtained exclusive commercialization rights, while Eli Lilly will continue to be responsible for manufacturing, supply, and ongoing development.

Significance: This marks the eighth collaboration between the two companies since the launch of their strategic partnership. By integrating Innovent Biologics’ established commercialization capabilities and extensive market coverage in China with Eli Lilly’s strengths in innovative drug R&D and full lifecycle management, the partnership aims to further enhance treatment accessibility and benefit more breast cancer patients in China.

Abbisko Therapeutics (02256.HK) — Strategic Partnership with AstraZeneca

Updates: On July 2, Akeso and AstraZeneca signed a strategic cooperation agreement to jointly advance clinical research on novel combination therapies targeting immune checkpoints for the treatment of non-small cell lung cancer (NSCLC). This study is a Phase I/II clinical trial evaluating the combination of Akeso’s oral small-molecule PD-L1 inhibitor ABSK043 with AstraZeneca’s third-generation EGFR-TKI osimertinib.

Significance: To treat patients with locally advanced or metastatic NSCLC harboring EGFR mutations and PD-L1 positivity, exploring the potential of combination therapy with a first-in-class oral small-molecule PD-L1 inhibitor and a third-generation EGFR-TKI.

BMS — Launches Phase III Clinical Trial of Iza-Bren as First-Line Treatment for EGFR-Mutated NSCLC

Update: On July 2, Bristol Myers Squibb registered the global Phase III clinical trial IZABRIGHT-Lung02, evaluating the EGFR/HER3 ADC novel drug Iza-Bren in combination with osimertinib versus osimertinib ± platinum-based chemotherapy as first-line treatment for EGFR-mutated NSCLC. The trial is expected to commence on September 30, 2026, with a planned enrollment of 850 patients, and is anticipated to be completed by the end of 2031.

Significance: The initiation of the first Phase III clinical trial for first-line treatment in the United States will trigger another $250 million milestone payment, bringing the cumulative upfront and milestone payments received by Biokin to nearly $1.3 billion. Iza-bren was officially approved for marketing on June 22 this year under the brand name Yizekang.

CSPC — siRNA Drug Licensed to AstraZeneca

Update: On July 2, CSPC and AstraZeneca entered into a collaboration, option, and license agreement to leverage CSPC’s proprietary siRNA drug discovery platform and extrahepatic targeted delivery platform for the development of novel small nucleic acid candidate drugs, aiming to jointly discover and develop preclinical candidates (PCCs) targeting two specific targets for the treatment of kidney diseases.$1.77 Billion! CSPC and AstraZeneca Strike Another Partnership）。

Significance: The total potential value of the collaboration reaches up to US$1.77 billion. CSPC will receive a US$30 million upfront payment, up to US$540 million in R&D milestones, up to US$1.2 billion in sales milestones, and single-digit sales royalties. CSPC retains the rights to develop, manufacture, and commercialize one of the PCCs in China (

Nonna Biotech — Strategic Partnership with Lonza

News: Nonna Biotech and Lonza have entered into a strategic partnership to jointly develop best-in-class blood-brain barrier (BBB) penetration technology based on single-domain antibodies for the treatment of central nervous system (CNS) diseases.

Significance: Leveraging the complementary synergy between Nuona Biologics’ fully human HCAb Harbour Mice® platform, Lonza’s GS Gene Expression System® expression system, and GlycoConnect® bioconjugation technology, we aim to create a best-in-class blood-brain barrier (BBB) penetration technology, enabling efficient delivery of various novel therapeutic molecules to the central nervous system (CNS). Nuona Biologics will receive an upfront payment and option exercise payments, along with future shared revenues from platform licensing.

Kehui Zhiyao — Nearly 100 Million Yuan in Series A Financing to Boost AI-Driven New Drug R&D

Updates: Kehui Zhiyao recently announced the completion of its Series A financing round, raising nearly RMB 100 million.

Significance: The funds will be used to increase investment in AI-driven new drug R&D and advance the progress of core pipelines.

CStone Pharmaceuticals (2616.HK) — Grants Arrotex Exclusive Commercialization Rights for Sugemalimab in Australia and New Zealand

News: CStone Pharmaceuticals recently entered into a collaboration agreement with Arrotex, granting it exclusive commercialization rights for sugemalimab in Australia and New Zealand.

Significance: To further expand the overseas market layout of sugemalimab and accelerate its internationalization process.

Global Regulatory Trends in Innovative Drugs

(Approved for Marketing/IND/Special Review)

China NMPA Regulatory Updates (Marketing Authorization Acceptance and Policies)

Savolitinib (brand name: Orpathys)^®）

Company: Hutchison Medicine (Shanghai)

Date: July 1, 2026

Details: The NMPA has approved a new indication for the world’s first MET-amplification-targeted therapy for gastric cancer, intended for adult patients with locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma harboring MET gene amplification who have failed at least two prior systemic therapies, thereby filling the therapeutic gap for MET-amplified targets in gastric cancer.

Intra-aneurysmal Embolization System (Innovative Medical Device)

Company: Beijing Taijie Weiye Technology Co., Ltd.

Date: June 29, 2026

Details: Approved by the NMPA for innovative product registration, indicated for endovascular embolization of small-to-medium wide-necked saccular intracranial aneurysms with a diameter of 3–15 mm, a neck width ≥4 mm, or a neck ratio of 1–2, thereby optimizing minimally invasive treatment strategies for wide-necked aneurysms.

Implantable Cardiac Event Monitor (ICM, Innovative Medical Device)

Enterprise: Suzhou Wushuang Medical Equipment Co., Ltd.

Date: July 1, 2026

Details: Approved for registration by the NMPA, this device is used to record subcutaneous electrocardiograms (ECG). It is suitable for long-term ECG screening in patients at high risk of arrhythmias or with unexplained transient syncope, filling the gap in domestically produced minimally invasive long-term ECG monitoring devices.

Optimized Review Policies for Cell and Gene Therapy (CGT)

Issuing Authority: General Department of the NMPA

Date: July 3, 2026

Details: Public consultation is underway on optimizing the review and approval process for cell and gene therapy (CGT) products. Class 1 innovative CGT drugs, including CAR-T therapies, AAV gene therapies, and oncolytic viruses, that meet specified criteria may enter a 30-day expedited review pathway for Investigational New Drug (IND) applications (compared to the standard 60 working days). The review timeline for post-approval manufacturing process changes has been reduced from 200 working days to 130 working days. Meanwhile, global multi-center concurrent clinical trials are being encouraged to accelerate the deployment of cell and gene therapies for solid tumors, rare diseases, and neurodegenerative disorders.

2026 National Reimbursement Drug List Preliminary Review Public Notice

Issuing Authority: National Healthcare Security Administration

Date: June 29, 2026

Details: 557 drug products passed the initial review, including 54 cutting-edge innovative drugs; a new pre-submission mechanism for innovative drugs was introduced, significantly shortening the cycle for new drugs to gain access to the National Reimbursement Drug List (NRDL); Lunkangyilongtuomab (Yizekang), the world’s first bispecific antibody-drug conjugate (ADC) approved on June 22, was included in the initial review list, raising expectations that it may participate in the national price negotiations and achieve price reductions in its launch year.

US FDA Regulatory Updates (Special Designations and Status)

Hybio Tirzepatide Injection (Generic Drug)

Company: Hybio Pharmaceutical

Date: June 29, 2026

Details: The FDA has formally accepted the ANDA application and entered the review phase. The pre-filled pen formulation covers all strengths of the originator product, with indications including type 2 diabetes in adults, chronic weight management, and obstructive sleep apnea. If approved, it will capture the 180-day generic drug exclusivity window against the originator (Domestically Produced “Tirzepatide” Files for U.S. Market Approval; Hybio Pharmaceutical Kicks Off Battle for First Generic of the “World’s Best-Selling Drug”）。

Roche Enspryng (Satralizumab)

Company: Roche

Date: June 30, 2026

Details: The FDA has accepted the supplemental Biologics License Application (BLA) for the treatment of Thyroid Eye Disease (TED), granting it Priority Review, with a PDUFA target date of October 15, 2026; if approved, it will become the world’s first home-administered subcutaneous targeted therapy for TED.

Orca-T (Tregzi, Cell Therapy)

Company: Orca Bio

Date: July 4, 2026

Details: The FDA has completed its review ahead of schedule, granting formal approval for market launch. This next-generation allogeneic Treg cell therapy is indicated for hematopoietic stem cell transplantation in patients with high-risk hematologic malignancies, significantly reducing the risk of post-transplant graft-versus-host disease (GVHD). It stands as a major milestone in cell therapy approvals this July.

Domestic ALS Drug ALT001 Receives Implicit IND Approval

Enterprise: Domestic Biotech Innovation Company

Date: June 30, 2026

Details: The FDA has granted implicit IND approval for a mesenchymal stem cell-derived protein complex therapy, paving the way for human clinical trials in amyotrophic lateral sclerosis (ALS). This marks significant progress for a domestically produced stem cell therapy for neurodegenerative diseases in its push toward U.S. clinical development.