InnoCare Pharma Launches Phase III for BCL-2 Inhibitor to Challenge AbbVie Head-to-Head; Health Insurance Instant Settlement Covers Over 90% of Designated Institutions

MILESTONE REPORT · AMINO INSIGHTS

InnoCare Pharma has secured approval from China's Center for Drug Evaluation (CDE) to launch a registrational Phase III trial for its novel oral BCL-2 inhibitor mesutoclax (ICP-248), setting up a direct head-to-head challenge against AbbVie's venetoclax in the treatment of acute myeloid leukemia. In a parallel development, China's National Healthcare Security Administration disclosed that instant settlement of health insurance funds now covers more than 90 percent of designated medical institutions nationwide, with the annual reform target achieved ahead of schedule.

InnoCare's BCL-2 Inhibitor Takes On the Venetoclax Monopoly

On August 18, Beijing InnoCare Pharma Tech Co., Ltd. announced that its proprietary high-selectivity oral BCL-2 inhibitor mesutoclax (ICP-248), in combination with azacitidine, has been approved by the CDE for a registrational Phase III clinical trial in treatment-naive acute myeloid leukemia (AML) among elderly patients or those unfit for intensive chemotherapy. The primary endpoint is overall survival (OS). The drug has already been designated a breakthrough therapy by the CDE on two separate occasions.

The clinical data package presented at the American Society of Clinical Oncology (ASCO) meeting is striking. Among treatment-naive AML patients, mesutoclax achieved a composite complete response rate (cCR) of 81.8 percent. Of those who responded overall, 86.5 percent reached minimal residual disease (MRD) negativity. Notably, 83 percent of cCR patients achieved remission within the first treatment cycle. Early mortality rates at both 30 days and 60 days were zero, and the six-month overall survival rate at the recommended dose stood at 90.5 percent.

The BCL-2 inhibitor market in AML has been dominated for years by AbbVie's venetoclax, which has faced little meaningful competition in the domestic Chinese market. InnoCare's strategy is clear: go head-to-head with superior data. The combination of an 81.8 percent cCR rate, rapid single-cycle remission, and zero early mortality speaks directly to the unmet needs of the elderly, unfit patient population. A registrational Phase III trial with OS as the primary endpoint, if successful, would deliver a hard-currency indication label that few competitors can match.

While numerous domestic players are pursuing the BCL-2 target, very few have secured entry into a registrational Phase III trial. InnoCare has effectively claimed a first-tier position in this race.

Health Insurance Instant Settlement Hits 90% Coverage

On August 17, China's National Healthcare Security Administration revealed that as of the end of July, health insurance departments nationwide had disbursed a total of RMB 945.731 billion in instant settlement funds to medical institutions, representing 95.51 percent of local monthly settlement volumes. The program now covers 752,200 designated medical and pharmaceutical institutions, exceeding the 90 percent threshold and completing the annual reform target ahead of schedule.

On the same day, the forthcoming Version 3.0 diagnosis-related group (DRG) payment classification scheme was announced, adding 158 newly selected grassroots-level disease categories at the national level: 31 under the DRG framework and 127 under the big data DIP (Diagnosis-Intervention Packet) framework. The core mechanism is "same disease, same payment" — within the same pooling region, grassroots disease categories will be reimbursed at identical payment standards regardless of whether treatment occurs at a primary care facility or a tertiary hospital.

The instant settlement mechanism addresses a critical pain point for medical institutions: cash flow. Payment cycles that once stretched over months have been compressed to a matter of days, significantly reducing the capital tied-up costs for both pharmaceutical companies and hospitals. The 158 grassroots disease categories under the "same disease, same payment" model, meanwhile, disrupt the economics of tiered diagnosis and treatment: when tertiary hospitals can no longer earn a margin differential on common diseases, the cost advantage of primary care institutions becomes a genuine competitive force for the first time. China's medical insurance payment reform is pivoting from pure price reduction to structural realignment.

Biokin's BL-B01D1 Reaches PFS Endpoint in Lung Cancer Phase III

Sichuan Biokin Pharmaceutical Co., Ltd. announced on August 18 that an interim analysis of its Phase III trial for BL-B01D1 (izabren), a self-developed EGFR×HER3 bispecific antibody-drug conjugate (ADC), has met the primary endpoint of progression-free survival (PFS) in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Overall survival (OS) showed a favorable trend.

BL-B01D1 is the world's first and only approved EGFR×HER3 bispecific ADC. Two indications — nasopharyngeal carcinoma and esophageal squamous cell carcinoma — have already received marketing approval, while a new drug application for triple-negative breast cancer has been accepted. The company is currently conducting more than 40 clinical trials across China and the United States, including 20 Phase III studies, with seven indications granted breakthrough therapy designation by the CDE. This marks the fifth consecutive Phase III study to reach its primary endpoint.

The bispecific ADC platform is the foundation of Biokin's landmark USD 8.4 billion business development deal with Bristol Myers Squibb. Each Phase III success paves the way for milestone payment realization. The consecutive string of positive trials demonstrates that the "bispecific antibody plus ADC" architecture is a replicable technology platform rather than a single-product stroke of luck. With lung cancer representing the largest oncology market, this PFS achievement signals the drug's advance from later-line to front-line positioning.

Harbour BioMed's B7H4×CD3 Bispecific Antibody Clears Clinical Approval in China

And Platinum Pharmaceutical (Shanghai) Co., Ltd., listed as Harbour BioMed (02142.HK), announced on August 18 that its investigational new drug application for HBM7004, a B7H4×CD3 bispecific antibody for the treatment of advanced solid tumors, has been approved by China's National Medical Products Administration. This follows the product's IND clearance from the U.S. Food and Drug Administration in May 2026, completing a dual China-U.S. regulatory filing.

HBM7004 was developed on Harbour BioMed's proprietary HBICE bispecific antibody platform. The B7H4 target is highly expressed across multiple solid tumor types while showing limited expression in normal tissues, positioning it as a next-generation immuno-oncology target. The industry has compared B7H4's potential to that of Claudin 18.2, with most global pipelines still in early stages. Harbour BioMed's dual-filing pace puts it ahead of the curve. For the company, HBM7004 validates the HBICE platform's capacity to consistently produce differentiated bispecific antibodies — the foundation of its strategic pivot from "licensed out" to "in-house development with retained global rights."

AstraZeneca's Tezepelumab Launches in China with Dual Indications

AstraZeneca announced on August 17 that tezepelumab (brand name Tezspire), a thymic stromal lymphopoietin (TSLP) monoclonal antibody, has officially launched in China for the maintenance treatment of severe asthma in adults and adolescents aged 12 and above, as well as for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients in combination with nasal corticosteroids. The drug received approval in March based on positive results from two Phase III studies: DIRECTION and WAYPOINT.

In the DIRECTION study, tezepelumab reduced annual asthma exacerbation rates by 74 percent overall and by 80 percent in the Chinese population. In the WAYPOINT study, nasal polyp scores decreased by 2.08 points, nasal congestion scores dropped by 1.04 points, the need for surgery was reduced by 98 percent, and systemic corticosteroid use declined by 89 percent.

Developed jointly by AstraZeneca and Amgen, tezepelumab is the first biologic to transcend phenotype and biomarker limitations by targeting TSLP, an upstream mediator of multiple inflammatory cascades. This "upstream" mechanism means the drug works regardless of whether a patient has eosinophilic or non-eosinophilic asthma — a key differentiator from IL-4Rα and IL-5 targeted monoclonal antibodies. With more than 40 million asthma patients in China and high surgical recurrence rates for CRSwNP, the dual-indication launch spreads promotional costs efficiently. The five-month gap from approval to commercial launch also signals that China is becoming a synchronous market for multinational corporations' global volume ramp-up, rather than a lagging one.

EyePoint's Faricimab Implant Fails Phase III; Betta Pharmaceuticals Plunges

EyePoint Pharmaceuticals (EYPT.US) saw its shares plunge 67 percent overnight on August 18 after its faricimab intravitreal implant DURAVYU failed to meet the primary endpoint in the Phase III LUGANO study for wet age-related macular degeneration (wAMD). Among 211 enrolled subjects, nine patients experienced vision loss due to non-wAMD causes: six cases of geographic atrophy, two of glaucoma, and one of retinal detachment. The full dataset did not meet the primary endpoint. A temporary analysis excluding this subgroup showed non-inferiority to aflibercept (nominal p=0.0096).

The company still plans to submit an FDA application in the first half of 2027, with data from a second Phase III trial, LUCIA, expected in the fourth quarter. Betta Pharmaceuticals (300558.SZ), which holds Greater China rights to the asset, hit the 20 percent daily limit down on the Shenzhen exchange.

Nine vision-loss events deemed unrelated to the drug derailed a Phase III trial — a collision of statistical subgroup interference and rare adverse events that will force the FDA into a difficult deliberation. For Betta Pharmaceuticals, the overnight plunge exposes the double-edged nature of overseas licensing rights: both upside and risk exposure are magnified simultaneously. The differentiated narrative of "dosing once every six months" remains intact, but the market has delivered its short-term verdict.

Chugai and GSK Strike Dengue Antibody Licensing Deal

On August 18, Chugai Pharmaceutical announced an exclusive licensing agreement with GlaxoSmithKline PLC., granting GSK global exclusive rights to develop, manufacture, and commercialize AID351, an anti-dengue virus antibody drug for the treatment of yellow fever virus infections including dengue fever. Specific financial terms of the transaction were not disclosed.

Dengue fever is the world's fastest-spreading mosquito-borne viral disease, infecting hundreds of millions annually, yet no approved specific antiviral therapy exists — the treatment market is effectively a vacuum. Chugai's export of antibody engineering technology to GSK, a company known for vaccine expertise, implies a "treatment plus prevention" synergy logic. As climate change continues to expand the geographic footprint of mosquito-borne diseases, neglected tropical diseases are emerging as a new pipeline battleground for multinational corporations.

AstraZeneca/Daiichi Sankyo's Enhertu Succeeds in First-Line Lung Cancer Phase III

On August 17, AstraZeneca and DAIICHI SANKYO PHARMACEUTICAL (SHANGHAI) CO., LTD jointly announced that Enhertu (fam-trastuzumab deruxtecan-nxki) achieved high-level positive results as a monotherapy in the first-line treatment of non-small cell lung cancer in the Phase III DESTINY-Lung04 study. Compared to the standard of care — pembrolizumab plus platinum-doublet chemotherapy — Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with advanced non-squamous NSCLC harboring HER2 exon 19 or 20 mutations. The study will continue to evaluate OS and other secondary endpoints.

This is the first ADC drug to prove in a Phase III trial that monotherapy first-line treatment outperforms the standard of care and improves PFS in NSCLC patients. Previously, Enhertu's NSCLC indication was limited to second-line use. By directly defeating the "Keytruda plus chemotherapy" gold standard, this result suggests that the first-line treatment paradigm for HER2-mutated lung cancer may be rewritten.

For the broader ADC sector, this represents a turning point from "later-line volume" to "first-line pricing." The first-line market is several times larger than later-line segments; whoever secures first-line approval first locks in the largest indication share. Competitive pressure on same-track players such as Biokin's BL-B01D1, which is also pursuing first-line Phase III trials, has intensified substantially.

Macau's "Third Five-Year Plan" Promises Free Community Healthcare

On August 18, the Macau Special Administrative Region government officially published the "Third Five-Year Plan for Economic and Social Development of Macau (2026–2030)." The plan proposes pushing medical resources down to the community level, providing free community healthcare and preventive services to all Macau residents, and building a comprehensive community medical service network in line with the World Health Organization's universal health coverage goals.

The "free community healthcare plus universal health coverage" model represents an extreme sample of tiered healthcare reform — government-funded primary care that uses preventive investment to offset later high treatment costs. For mainland China's pharmaceutical industry, the reference point is clear: the decentralization of medical resources to the community level is a nationwide trend, underscored by the same-day launch of "same disease, same payment" for grassroots conditions. The expansion of primary care drug formularies, chronic disease management, and home-use medical devices represent the most policy-certain growth directions in the sector.

YimuFeng Files for Hong Kong IPO; CLDN18.2 CAR-T Pushes Into Solid Tumor Phase III

On August 18, Shenzhen YimuFeng Biotech submitted a listing application to the Hong Kong Stock Exchange main board, with Huatai International as the sole sponsor. This marks the company's second filing attempt after its February submission lapsed. The core product, IMC002, is an anti-CLDN18.2 CAR-T cell therapy currently in a registrational Phase III clinical trial in China for CLDN18.2-positive advanced gastric cancer and gastroesophageal junction adenocarcinoma. In June 2026, the company filed an IND for first-line pancreatic cancer treatment. According to Frost & Sullivan, IMC002 is the second-fastest advancing solid tumor CAR-T globally in clinical development.

The company has raised approximately RMB 973 million cumulatively, with its valuation doubling from RMB 1.016 billion to RMB 2.075 billion within six months. Losses in the first half of 2026 totaled RMB 109 million.

Solid tumor CAR-T represents the "no man's land" of cell therapy — virtually all commercialized CAR-T products are concentrated in hematological malignancies. Whoever successfully completes a registrational Phase III in solid tumors first captures next-order-of-magnitude pricing power. YimuFeng's valuation doubling in six months reflects capital betting on precisely this scarcity. The Hong Kong 18A listing channel remains open for "late-stage clinical plus differentiated narrative" pricing windows.

Source: AMINO INSIGHTS · Biopharma Industry Daily Briefing

Data verified against original publication. All financial figures denominated in RMB (CNY) unless otherwise stated (USD noted for BMS transaction).