This week’s China healthcare updates spotlight significant developments in IPOs, licensing deals, and breakthrough therapies. Lupeng Pharma filed for an HKEX IPO, aiming to advance its fourth-generation BTK inhibitor rocbrutinib (LP-168), which targets B-cell malignancies. Conditional approval for rocbrutinib is expected from the NMPA in June 2026, supported by Phase II data showing a 63.9% ORR and a low 0.7% TRAEs discontinuation rate. Innovent Biologics announced a landmark US$10.5 billion oncology collaboration with Pfizer, covering 12 early-stage programs with co-development and co-commercialization for four. TenNor Therapeutics surged post-HKEX listing, supported by a late-stage antibacterial pipeline, with rifasutenizol achieving a 92% eradication rate in resistant H. pylori patients. Maxvax Biotech filed for a STAR Market IPO, raising RMB 2.93 billion for its recombinant zoster vaccine. Meanwhile, MediLink achieved global prominence as its B7-H3 ADC tambotatug pelitecan became the first in its class to succeed in a Phase III trial, showing significant ORR improvement in metastatic nasopharyngeal carcinoma. These milestones underscore China’s leadership in advancing innovative drug pipelines, fostering global partnerships, and expanding therapeutic impact.

Transactions & BD (In/Out Licensing)

Lupeng Pharma Files for Hong Kong IPO with Fourth-Generation BTK Inhibitor Rocbrutinib Nearing Approval

Key Words: Lupeng Pharma, HKEX IPO, rocbrutinib, LP-168, BTK inhibitor, B-cell malignancies, mantle cell lymphoma, BeyondX

• The News: Lupeng Pharma filed for a Hong Kong IPO to support development and commercialization of its oncology and autoimmune disease pipeline. The company’s core asset rocbrutinib (LP-168), a fourth-generation BTK inhibitor, submitted a China NDA in May 2025 and is expected to receive conditional approval from NMPA in June 2026.
• Key Highlights:
• Deal Details:
  • Raised approximately US$ 213.2 million across multiple financing rounds.
  • Latest Valuation: Post-money valuation reached approximately US$311.3 million in the latest round.
  • Financial Profile: Reported a net loss of RMB 207 million in 2025, net liabilities of RMB 1.068 billion and cash reserves of approximately RMB 682 million as of year-end 2025.
• Core Product – Rocbrutinib / LP-168:
  • Rocbrutinib / LP-168: A fourth-generation BTK inhibitor with dual covalent and non-covalent binding activity, being developed for B-cell malignancies.
  • Mechanism: Designed to inhibit both wild-type BTK and resistance-associated BTK mutations through a dual binding mechanism, aiming to address resistance to earlier-generation BTK inhibitors.
  • Regulatory Status: China NDA submitted in May 2025 based on Phase II data, with conditional approval expected in June 2026.
• Clinical Data:
  • Relapsed / Refractory Mantle Cell Iymphoma: Showed an ORR of 63.9%, median PFS of 7.39 months, complete response rate of 23.0% and 12-month DoR rate of 61.2%.
  • Safety: Treatment discontinuation due to TRAEs was reported at 0.7%, lower than disclosed rates for several approved BTK inhibitor
• Lupeng Pharma is a clinical-stage biotech focused on oral small-molecule therapies for oncology and autoimmune diseases, supported by its BeyondX oral medicinal chemistry platform.

Innovent Biologics (1801.HK) and Pfizer (PFE.N) Sign US$ 10.5 Billion Global Oncology Collaboration Across 12 Early-Stage Programs

Key Words: Innovent Biologics, Pfizer, global strategic collaboration, oncology, co-development, co-commercialization, Co-Co, early-stage pipeline, licensing

• The News: Innovent Biologics entered a global strategic collaboration with Pfizer covering 12 early-stage oncology programs. Under the agreement, Innovent will receive US$ 650 million upfront and is eligible for up to US$ 9.85 billion in development, regulatory and commercial milestone payments, bringing total potential deal value to US$ 10.5 billion.
• Key Highlights:
• Deal Details:
  • Total Deal Value: Up to US$ 10.5 billion.
  • Upfront Payment: US$ 650 million.
  • Milestone Payments: Up to US$ 9.85 billion tied to development, regulatory and commercial progress.
  • Programs Covered: 12 early-stage oncology innovative drug programs.
  • Co-Co Structure: Four core programs will be jointly developed globally by Innovent and Pfizer, with joint commercialization and profit sharing in the U.S. and Europe.
  • The Co-Co programs give Innovent exposure to U.S. and European commercial economics beyond traditional royalty-based licensing.

TenNor Therapeutics (6872.HK) Surges After HKEX Listing, Backed by Late-Stage Anti-Infective Pipeline

Key Words: TenNor Therapeutics, HKEX IPO, anti-infective drugs, rifasutenizol, TNP-2198, rifaquizinone, TNP-2092, H. pylori, PJI, antimicrobial resistance

• The News: TenNor Therapeutics listed on the Hong Kong Stock Exchange on May 22, 2026. The company priced its IPO at HK$ 75.70 per share, with the public offering reportedly over 9,000x subscribed. Shares opened 137% above the offer price and later closed at HK$ 210 per share, representing a 177.4% increase from the IPO price.
• Key Highlights:
• Deal Details:
  • Listing Date: May 22, 2026.
  • Offer Price: HK$75.70 per share.
  • Trading Performance: Shares opened 137% and closed at HK$ 210, up 177.4% from the offer price.
  • Market Capitalization: Approximately HK$ 11 billion based on the latest trading level.
• Product Profile – Rifasutenizol / TNP-2198:
  • Rifasutenizol / TNP-2198: A first-in-class NME antibacterial candidate specifically developed for Helicobacter pylori infection.
  • China NDA submitted in August 2025, and approval expected by end-2026.
  • Mechanism: A dual-pharmacophore molecule combining rifamycin and nitroimidazole components, designed to inhibit RNA polymerase and nitroreductase-related pathways for synergistic activity against microaerophilic and anaerobic bacteria.
  • Indication Focus: H. pylori infection, with additional development potential in bacterial vaginosis and Clostridioides difficile infection.
  • Clinical Data: In a head-to-head Phase III study, TNP-2198 triple therapy achieved an eradication rate of 92.0% vs. 87.9% for bismuth quadruple therapy; in multi-drug-resistant patients, eradication rates were 89.9% vs. 81.2%.
  • Safety: Adverse event rate was 37.3% for the TNP-2198 regimen vs. 53.2% for bismuth quadruple therapy, with no drug-related serious adverse events reported.

Maxvax Biotech Files STAR Market IPO to Raise RMB 2.93 Billion, Led by Recombinant Zoster Vaccine MKK100

Key Words: Maxvax Biotech, STAR Market IPO, MKK100, recombinant zoster vaccine, MA105 adjuvant, MKK900, RSV vaccine, innovative vaccines

• The News: Maxvax Biotech’s STAR Market IPO application was accepted on May 27, 2026. The company plans to raise RMB 2.93 billion to support core vaccine R&D, innovative vaccine pipeline development, manufacturing base construction and commercial network buildout. Its lead asset MKK100, a recombinant zoster vaccine using the company’s proprietary MA105 adjuvant system, entered NDA review in China in October 2025.
• Key Highlights:
• Deal Details:
  • IPO Status: STAR Market listing application accepted.
  • Offering Size: No less than 12.90 million shares, representing no less than 25% of post-IPO share capital.
  • Fundraising Target: RMB 2.93 billion.
• Product Profile – MKK100:
  • MKK100: A recombinant zoster vaccine using Maxvax’s proprietary MA105 adjuvant system, being developed for prevention of herpes zoster in adults aged 40 years and older.
  • China NDA submitted in October 2025, and potential commercialization expected in 2027.
  • Mechanism: Designed to induce humoral and cellular immune responses against varicella-zoster virus through a recombinant protein antigen plus novel adjuvant system.
  • Clinical Data: In Phase III, MKK100 showed >90% efficacy against herpes zoster at 30 days after full vaccination in adults aged ≥40 years.
  • Safety: Grade 3 adverse reaction rate was below 1% in Phase III. In a Phase II head-to-head study, the Grade 3 adverse reaction rate for MKK100 was reported at approximately one-eighth of Shingrix.
• Maxvax Biotech is a Chengdu-based vaccine company focused on innovative vaccines and novel adjuvant systems across infectious diseases, allergic diseases and oncology.

CordenPharma to Acquire Peptide API CDMO AmbioPharm

Key Words: CordenPharma, AmbioPharm, peptide CDMO, peptide API, SPPS, LPPS, TAPS, global manufacturing network

• The News: CordenPharma signed an agreement to acquire AmbioPharm, a peptide API CDMO with manufacturing sites in South Carolina, U.S. and Shanghai, China. The acquisition will strengthen CordenPharma’s peptide API platform, expand its global manufacturing footprint and enhance its ability to support complex, long-chain and high-purity peptide projects.
• Key Highlights:
• Technology / Manufacturing Capabilities:
  • Peptide Synthesis: The combined company will gain enhanced capabilities in linear peptide synthesis and fragment-based peptide synthesis.
  • Manufacturing Technologies: AmbioPharm brings flexible SPPS, LPPS and hybrid peptide synthesis capabilities.
  • TAPS Platform: The acquisition complements CordenPharma’s proprietary tag-assisted peptide synthesis technology.
• Peptide CDMO Expansion: The acquisition strengthens CordenPharma’s position in the fast-growing peptide API CDMO market.
• GLP-1 / Peptide Demand Tailwind: Rising global demand for peptide-based therapeutics, especially metabolic drugs, is driving the need for scalable peptide API capacity.
• AmbioPharm is a peptide API-focused CDMO with manufacturing operations in the U.S. and China, specializing in complex peptide synthesis, purification and lyophilization for clinical and commercial supply.

SinoCellTech (688520.SS) Files for Hong Kong IPO to Build A+H Capital Platform

Key Words: SinoCellTech, Hong Kong IPO, A+H listing, Anjiayin, recombinant factor VIII, HPV vaccine, biologics, pipeline expansi

• The News: SinoCellTech, a China-based biologics company founded in 2002 and listed on the STAR Market in 2020, submitted its Hong Kong IPO application, aiming to establish an A+H dual-listing platform to support commercialization scale-up, late-stage pipeline development and global expansion.
• Key Highlights:
• SinoCellTech applied for a Hong Kong listing, seeking to build an A+H dual-capital platform.
• Existing Listing: Has been listed on the STAR Market since 2020.
• Core Product – Anjiayin / SCT800:
  • Anjiayin / SCT800: A third-generation, albumin-free recombinant human coagulation factor VIII replacement therapy.
  • Mechanism: Anjiayin supplements functional factor VIII, restoring activity in the intrinsic coagulation pathway and supporting thrombin generation and clot formation.
  • Indication: Hemophilia A, including routine prophylaxis, on-demand bleeding control and perioperative bleeding management.
  • According to the provided materials, Anjiayin ranked first in China’s recombinant factor VIII market from 2023, with a 35.5% market share in 2024.
• SinoCellTech is a China-based biologics company focused on recombinant proteins, monoclonal antibodies and vaccines across rare diseases, oncology, autoimmune diseases, ophthalmology and vaccines.

Fosun Pharma (2196.HK) In-Licenses Genrix’s (688443.SH) BCMA/CD3 Bispecific Antibody GR1803 in Deal Worth Up to RMB 1.82 Billion

Key Words: Fosun Pharma, Genrix, Yao Pharma, GR1803, vilitomimab, BCMA/CD3 bispecific antibody, multiple myeloma, Greater China rights, licensing

• The News: Fosun Pharma entered a strategic collaboration with Genrix Biopharma, with its subsidiary Yao Pharma obtaining exclusive Greater China rights to GR1803, a BCMA/CD3 bispecific antibody developed by Genrix. The deal includes up to RMB 600 million in upfront, approval and technology-transfer milestone payments, plus up to RMB 1.22 billion in sales milestones.
• Key Highlights:
• Deal Detail:
  • Total Deal Value: Up to RMB 1.82 billion.
  • Upfront / Regulatory / Tech-transfer Payments: Up to RMB 600 million, including up to RMB 300 million upfront, RMB 250 million approval milestone and RMB 50 million technology-transfer milestone.
  • Sales Milestones: Up to RMB 1.22 billion based on annual net sales in the licensed territory.
• Product Profile – Velinotamig (GR1803):
  • Velinotamig (GR1803): A BCMA/CD3 bispecific antibody being developed for relapsed / refractory multiple myeloma, with China conditional NDA accepted in January 2026 and included in Priority Review.
  • Mechanism: Designed to bind BCMA on myeloma cells and CD3 on T cells, redirecting T cells to kill BCMA-expressing tumor cells.
  • Conditional approval application accepted by China NMPA; clinical development in autoimmune diseases including systemic lupus erythematosus is also ongoing.
• Prior Licensing: In June 2025, Genrix licensed ex-China rights to GR1803 to Cullinan Therapeutics in a deal worth up to US$ 712 million.
• Genrix Biopharmaceutical is a Shanghai-listed biotech focused on antibody-based therapies across oncology, autoimmune and other immune-mediated diseases.

Xingyao Kunze Raises Over RMB 630 Million Series B to Advance Liver Disease Pipeline

Key Words: Xingyao Kunze, HT-101, HT-102, siRNA, HBV, HBsAg clearance, liver disease, Series B financing, Fosun Pharma

• The News: Xingyao Kunze completed a Series B financing of over RMB 630 million, with participation from Fosun Pharma, Kaitai Capital, Huajin Investment, TG Sino-Dragon Fund II, Qianhe Capital, Decheng Capital, Taihao Ventures and other investors. Fosun Pharma also disclosed a planned investment of approximately RMB 414 million, after which it would hold 20.87% equity in Xingyao Kunze.
• Key Highlights:
• Deal Details:
  • Financing Size: Over RMB 630 million Series B financing.
  • Fosun Participation: Fosun Pharma (2196.HK) plans to invest approximately RMB 414 million, including new share subscription and equity transfer.
  • Post-transaction Holding: Fosun Pharma will hold 20.87% of Xingyao Kunze after the transaction.
• Product Profile:
  • HT-101 / siRNA: A GalNAc-conjugated siRNA candidate designed to target hepatocytes and silence HBV transcripts, including mRNA derived from cccDNA and integrated DNA, thereby reducing HBsAg and other viral protein production.
  • HT-102 / Neutralizing Antibody: A fully human neutralizing antibody designed to capture and clear circulating HBsAg and subviral particles, aiming to reduce immune suppression and restore antiviral immune response.
  • HT-101 + HT-102: Received China NMPA Breakthrough Therapy Designation in September 2025.
• Xingyao Kunze is a China-based biotech focused on innovative liver disease therapies, developing RNAi, antibody, fusion protein and gene therapy approaches for HBV, NASH, liver fibrosis, liver regeneration and autoimmune liver diseases.

CR Therapeutics Raises Nearly RMB 100 Million to Advance Next-Generation Universal Cell Therapy Programs

Key Words: CR Therapeutics, financing, universal cell therapy, in vivo CAR-T, mRNA-LNP, TCR-T in vivo, therapeutic vaccine, CR101, EBV-associated tumors

• The News: CR Therapeutics completed a nearly RMB 100 million financing round to support clinical development of its next-generation universal cell therapy pipeline. The round was co-led by Chengdu Future Industry Fund and Yuanbio Venture Capital, with participation from Renyou Investment, Shengjing Jiacheng and existing investor Legend Capital.
• Key Highlights:
• Deal Detail:
  • Financing Size: Nearly RMB 100 million.
  • Lead Investors: Chengdu Future Industry Fund and Yuanbio Venture Capital.
• Drug Profile – CR101:
  • CR101: An in vivo TCR-T therapeutic vaccine targeting EBV-associated tumors, designed to induce durable and broad T-cell immune responses without ex vivo cell manufacturing.
  • Indication: EBV-associated malignancies, including nasopharyngeal carcinoma.
  • Mechanism: Activates antigen-specific T-cell immunity in vivo to recognize and eliminate EBV-positive tumor cells.
  • Regulatory Status: Received U.S. FDA Orphan Drug Designation for nasopharyngeal carcinoma.
• CR Therapeutics is a Chengdu-based biotech focused on next-generation universal cell therapies, including in vivo CAR-T and therapeutic vaccine platforms.

YolTech Therapeutics Raises Nearly RMB 500 Million to Advance in vivo Gene Editing Pipeline

Key Words: YolTech Therapeutics, Series C financing, in vivo gene editing, LNP delivery, YOLT-201, YOLT-203, ATTR, primary hyperoxaluria

• The News: YolTech Therapeutics completed a nearly RMB500 million Series C financing round to advance its in vivo gene editing pipeline toward late-stage clinical development and commercialization preparation. The round was led by Loyal Valley Capital, with participation from Shanghai State-owned Capital Investment, Minhang Financial Investment, Deyue Investment and existing investors including XVC, YuanBio Venture Capital and T-Capital.
• Key Highlights:
• Deal Details:
  • Financing Size: Nearly RMB 500 million Series C financing.
  • Lead Investor: Loyal Valley Capital.
• Core Product – YOLT-201:
  • YOLT-201: An LNP-delivered in vivo gene editing therapy targeting TTR, being developed for transthyretin amyloidosis.
  • Mechanism: Designed to edit the TTR gene in vivo after systemic LNP delivery, reducing production of disease-causing transthyretin protein.
  • YOLT-201 has completed dosing of all patients in its Phase I/IIa study.
• Key Product – YOLT-203:
  • YOLT-203: An in vivo gene editing therapy targeting HAO1, being developed for primary hyperoxaluria type 1, with US FDA clearance to enter confirmatory clinical development.
  • Mechanism: Designed to edit HAO1 in the liver and reduce oxalate production, addressing the metabolic driver of primary hyperoxaluria.
• YolTech Therapeutics is a China-based biotech focused on in vivo gene editing therapies for rare genetic diseases and chronic metabolic diseases.

Clinical

Hengrui’s (1267.HK) Oral Small-molecule GLP-1 HRS-7535 Hits Phase III in Type 2 Diabetes

Key Words: Hengrui Pharma, Kailera Therapeutics, HRS-7535, KAI-7535, oral GLP-1 receptor agonist, type 2 diabetes, obesity, Phase III

• The News: Hengrui Pharma and Kailera Therapeutics (KLRA.O) announced positive topline results from the Phase III OUTSTAND-1 study of HRS-7535 (KAI-7535), a once-daily oral small-molecule GLP-1 receptor agonist, in adults with type 2 diabetes inadequately controlled by diet and exercise. Hengrui plans to submit an NDA in China for type 2 diabetes, while additional studies are ongoing in overweight / obesity, including Hengrui’s China Phase III HARBOR-1 study and Kailera’s global Phase II obesity trial.
• Key Highlights:
• Clinical Data:
  • Study Design: A multicenter, randomized, double-blind, placebo-controlled Phase III trial enrolling 284 adults with type 2 diabetes.
  • Primary Endpoint: Change in HbA1c from baseline at Week 32.
  • HbA1c Reduction / Hypothetical Estimand: At Week 32, HbA1c reductions were 1.40%, 1.48% and 1.68% for the 30mg, 60mg and 90mg groups, respectively, vs. 0.06% for placebo.
  • Glycemic Control: HbA1c <7.0% achievement rates were 83.5%, 89.6% and 86.6% for the three HRS-7535 dose groups, vs. 14.8% for placebo.
  • Metabolic Benefits: Showed improvements in body weight, systolic blood pressure, lipid profile and UACR at Week 32.
• Product Profile – HRS-7535 (KAI-7535):
  • HRS-7535 (KAI-7535): Once-daily oral small-molecule GLP-1 receptor agonist.
  • Indication: Type 2 diabetes, with additional development in overweight / obesity.
  • Mechanism: Activated the GLP-1 receptor to improve glucose-dependent insulin secretion, suppress glucagon, slow gastric emptying and reduce appetite, supporting both glycemic control and weight reduction
• China NDA: Hengrui plans to submit HRS-7535 for type 2 diabetes treatment in China.
• Hengrui’s China Phase III HARBOR-1 trial in overweight / obesity is ongoing, with data expected in 2026.

Hengrui’s (1267.HK) HRS-5635 Becomes First HBV siRNA to Enter Phase III

Key Words: Hengrui Pharma, HRS-5635, HBV, siRNA, chronic hepatitis B, Phase III, HBeAg-negative

• The News: Hengrui Pharma’s HBV siRNA candidate HRS-5635 has initiated its first Phase III clinical study, making it the first HBV siRNA therapy globally to reach Phase III development. The trial will evaluate HRS-5635 in nucleos(t)ide analogue-suppressed, HBeAg-negative chronic hepatitis B patients.
• Key Highlights:
• Clinical Data:
  • Study Design: A randomized, multicenter, double-blind, placebo-controlled Phase III trial.
  • Enrollment: Approximately 540 patients.
  • Patient Population: Nucleos(t)ide analogue-suppressed, HBeAg-negative patients with chronic hepatitis B. HBeAg is commonly used as a clinical marker related to HBV replication and disease status.
  • Primary Endpoint: Proportion of patients maintaining HBV DNA suppression and HBeAg-negative status within 24 weeks after discontinuing all HBV therapies.
  • Phase I Data: Patients receiving HRS-5635 once every four weeks showed HBeAg reductions of 1.615 – 1.886 log10 IU/mL, compared with 0.009 log10 IU/mL in the placebo group.
• Drug Profile – HRS-5635:
  • HRS-5635: An investigational siRNA therapy for chronic hepatitis B.
  • Mechanism: Designed to silence HBV-related transcripts, thereby reducing viral antigen production and supporting functional-cure strategies.
  • Administration: Injection, with Phase I data showing once-every-four-week dosing.
  • First-in-class Potential: HRS-5635’s Phase III entry strengthens its position as a potential leading HBV siRNA therapy.

Biokin’s (688506.SS) EGFR/HER3 Bispecific ADC Iza-bren Nears Potential First Approval

Key Words: Biokin, SystImmune, BL-B01D1, iza-bren, EGFR/HER3 bispecific ADC, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, BMS

• The News: Biokin’s core asset BL-B01D1 / iza-bren is moving toward potential regulatory approval in China, with two NDA applications accepted by CDE for nasopharyngeal carcinoma and esophageal squamous cell carcinoma. If approved within 2026, iza-bren could become the world’s first commercialized bispecific ADC.
• Key Highlights:
• Biokin submitted an NDA for iza-bren in nasopharyngeal carcinoma, based on interim Phase III data from BL-B01D1-303, which met the primary endpoint.
• Product Profile – BL-B01D1 / iza-bren:
  • BL-B01D1 / iza-bren: A first-in-class EGFR/HER3 bispecific antibody-drug conjugate.
  • Targets: EGFR and HER3, two tumor-associated receptor tyrosine kinase family members involved in tumor growth and survival signaling.
  • Mechanism: Targeted EGFR- and HER3-expressing tumor cells, blocks tumor growth-related signaling and delivers a cytotoxic payload through ADC-mediated internalization to induce tumor cell death.
  • Indications: NDA-stage development in nasopharyngeal carcinoma and esophageal squamous cell carcinoma.
• Clinical Data:
  • Nasopharyngeal Carcinoma: The NDA was supported by the Phase III BL-B01D1-303 study, where interim analysis met the primary endpoint.
  • Esophageal Squamous Cell Carcinoma: The NDA was supported by the Phase III BL-B01D1-305 study, where the pre-planned interim analysis met both primary endpoints of PFS and OS.

CSPC’s (1093.HK) / Alphamab’s (9966.HK) HER2 Bispecific Antibody Anbenitamab Approved in China

Key Words: CSPC, Alphamab Oncology, Anbenitamab, KN026, HER2 bispecific antibody, gastric cancer, GEJ adenocarcinoma, NMPA approval

• The News: CSPC’s subsidiary Shanghai JMT-Bio received NMPA approval for anbenitamab injection, branded as Ennitamab, through Priority Review. The drug is approved in combination with chemotherapy for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least one prior trastuzumab-containing regimen.
• Key Highlights:
• Clinical Data:
  • Study Design: Pivotal Phase II/III KN026-001 study enrolled 188 patients with HER2-positive advanced unresectable or metastatic gastric / GEJ adenocarcinoma after first-line treatment failure.
  • Efficacy: Median PFS was 7.1 months for anbenitamab plus chemotherapy versus 2.7 months for control, with HR of 0.25 and p<0.0001.
  • Overall Survival: Median OS was 19.6 months versus 11.5 months, with HR of 0.29 and p<0.0001.
  • Safety: Grade ≥3 TRAEs occurred in 60.0% of the anbenitamab arm vs. 45.0% in the control arm; Grade ≥3 neutropenia occurred in 30.0% vs. 22.0%.
• Product Profile – Anbenitamab / KN026:
  • Anbenitamab / KN026: A HER2 bispecific antibody targeting two clinically validated HER2 epitopes, domain II and domain IV, approved in China in combination with chemotherapy for previously treated HER2-positive gastric / GEJ adenocarcinoma.
  • Mechanism: Designed to enhance HER2 receptor binding, dual-block HER2-mediated signaling, promote HER2 downregulation and retain Fc-mediated ADCC activity through a wild-type Fc region.
  • Regulatory Status: First domestically developed HER2 bispecific antibody approved in China.

Roche’s (SWX: ROP) MASH Candidate Pegozafermin Granted Breakthrough Therapy Designation in China

Key Words: Roche, pegozafermin, 89bio, metabolic dysfunction-associated steatohepatitis, MASH, FGF21 analogue, Breakthrough Therapy Designation, CDE

• The News: Roche’s FGF21 analogue, pegozafermin, has been granted Breakthrough Therapy Designation (BTD) by China’s Centre for Drug Evaluation (CDE) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The drug was acquired by Roche as part of its USD 3.5 billion takeover of 89bio in September 2025. The designation is expected to expedite the regulatory review process in China, providing a faster pathway to address MASH’s significant unmet medical needs.
• Key Highlights:
• Pegozafermin was added to Roche’s pipeline following the US$ 3.5 billion acquisition of 89bio in 2025.
• Clinical Data – ENLIVEN Phase II Trial:
  • Study Design: A Phase II clinical trial evaluating pegozafermin in patients with stage 2 or 3 fibrosis caused by MASH.
  • Efficacy Results:
  • 27% of patients receiving the 44 mg dose achieved at least a one-stage improvement in fibrosis without worsening of MASH.
  • Comparison: Only 7% of patients in the placebo group achieved similar improvements.
  • Drug Profile – Pegozafermin:
• Mechanism: A novel FGF21 analogue with dual anti-fibrotic and anti-inflammatory activity to target both key drivers of MASH progression.
• Regulatory Status: The BTD designation by the CDE is expected to accelerate pegozafermin’s approval timeline in China.

MediLink’s B7-H3 ADC Tambotatug Pelitecan Succeeds in Phase III Nasopharyngeal Carcinoma Trial

Key Words: MediLink Therapeutics, tambotatug pelitecan, B7-H3 ADC, nasopharyngeal carcinoma, TAISHAN-301, PD-1/L1 inhibitor, TMALIN linker-payload, Breakthrough Therapy Designation, Orphan Drug Designation

• The News: MediLink Therapeutics announced that its B7-H3-targeting antibody-drug conjugate (ADC), tambotatug pelitecan, met one of the dual primary endpoints in the Phase III TAISHAN-301 trial. The study focused on recurrent/metastatic nasopharyngeal carcinoma (NPC) and achieved a statistically significant improvement in the objective response rate (ORR) as assessed by blinded independent central review (BICR), while overall survival (OS) data remain immature. This marks the first global Phase III success for a B7-H3 ADC candidate.
• Key Highlights:
• Clinical Data – TAISHAN-301 Trial:
  • Study Design: A randomized Phase III trial comparing tambotatug pelitecan to investigator’s choice of chemotherapy for recurrent/metastatic NPC patients.
  • Patient Population: Enrolled patients who had failed prior PD-1/L1 inhibitor therapy and at least two lines of chemotherapy.
• Endpoints:
  • Achieved a statistically significant improvement in ORR as determined by BICR.
  • Overall survival (OS) data remain immature and follow-up is ongoing.
• Product Profile: Tambotatug pelitecan is a B7-H3-targeting ADC leveraging MediLink’s proprietary TMALIN linker-payload platform to enhance efficacy and reduce systemic toxicity.
• Regulatory Milestones:
  • Multiple Breakthrough Therapy Designations (BTDs) in China and US.
  • Three Orphan Drug Designations (ODDs) granted in US.
• Licensing Agreement:
  • In January 2026, MediLink secured an exclusive licensing agreement for tambotatug pelitecan, granting global rights outside Greater China to a partner.
  • Deal Terms: Milestone payments totaling US$ 570 million, including upfront and near-term milestones, plus additional royalties.

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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