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I. Three Class 1 Innovative Drugs Approved in One Week——Domestic Innovation Enters Intensive Commercialization Phase

In mid-August, the pace of innovative drug approvals in China accelerated further.

On August 11, Yateng Pharmaceutical's independently developed multi-target kinase inhibitor tinengotinib tablets (Jieentai®) received NMPA approval. This is the world's first therapeutic drug addressing FGFR inhibitor resistance in cholangiocarcinoma, and has received both FDA Fast Track designation and Orphan Drug designation. Cholangiocarcinoma patients develop acquired resistance after FGFR inhibitor therapy, typically carrying one or more mutations——creating extremely high R&D barriers that have led multiple overseas pharmaceutical companies to abandon their programs. Jieentai® offers a Chinese-originated solution for these patients who previously had no treatment options.

On August 13, TJ Biopharma announced that its felzartamab for injection (Jingfei®) received NMPA approval for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy. This marks the global-first approval of this product. Jingfei® is a CD38-targeting humanized monoclonal antibody. In April of this year, TJ Biopharma had already entered a strategic partnership with Biogen, with a total deal value of $850 million. As the company's chairman noted, Chinese innovative drugs are completing a fundamental role transformation——from "importing" to "out-licensing."

In the same week, the NMPA also approved a new indication for Conbio's ivwosi monoclonal antibody (Yidafang®) in combination with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer——its third indication in lung cancer.

With three Class 1 innovative drugs approved in a single week, the industry is transitioning from "clinical data delivery" to "commercialization delivery."

II. AI Pharma: NewCo Model Lands, Financing Remains Active

The AI pharma sector also released important signals in mid-August.

On August 14, BioMap announced a technology cooperation transaction under the NewCo structure with Biogend Therapeutics, a newly established AI-driven innovative biotherapy company. Under the agreement, BioMap will receive up to tens of millions of dollars in cash consideration and a high double-digit equity stake in the NewCo. Unlike previous NewCo models centered on single-asset licensing, Biogend aims to in-license BioMap's AI discovery system to continuously and batch-develop innovative bispecific/multispecific antibody pipelines in the immunology space. This model upgrade signals that AI pharma is moving from "single-molecule development" to "systematic pipeline incubation."

On August 10, Aureka Biotechnologies announced the completion of a $100 million Series B financing round. This AI-native TechBio company, founded in 2023, had just completed a Series A+ round in April of this year, with cumulative prior financing approaching $100 million. Founder Zhao Weian pointed out that AI-designed preclinical molecules can be acquired for tens of millions of dollars in upfront payments plus hundreds of millions in milestones——compressing front-end discovery to 1-1.5 years enables faster BD monetization and quicker returns for investors.

The bigger picture: according to a Ping An Securities report, the number of AI-driven clinical drug pipelines has grown from 4 in 2017 to 179 by June 2026. The overall success rate of AI-discovered drug molecules has improved from 5%-10% to 9%-18%, with Phase I clinical success rates reaching 80%-90%.

III. GLP-1 Pipeline: Ascletis' ASC30 Receives FDA Phase III Clearance

The GLP-1 space continued to deliver new developments in August.

On August 3, Ascletis Pharma's core product ASC30——an oral once-daily small-molecule GLP-1——received FDA clearance to initiate a global Phase III clinical study. Phase II data showed that at 13 weeks, the 20 mg, 40 mg, and 60 mg maintenance dose groups achieved placebo-adjusted mean weight reductions of 5.4%, 7.0%, and 7.7%, respectively——with dose-dependent efficacy and no plateau observed. ASC30's gastrointestinal adverse event profile was comparable to orforglipron, with all adverse events being mild to moderate and no drug-related serious adverse events. The company expects to announce Phase III topline data in Q3 2028 and file an NDA with the FDA by the end of 2028.

Additionally, Ascletis' ASC47 demonstrates weight loss without muscle loss. In combination studies with semaglutide, the 60 mg combination group showed a 110.4% relative improvement in weight loss compared to semaglutide monotherapy at day 57, with significantly better gastrointestinal tolerability (vomiting rate 6.7% vs 57.1%).

IV. BD Out-licensing: The $110 Billion Wave Enters the "Earnings Delivery" Test Phase

BD out-licensing remains one of the most closely watched industry signals in mid-August.

In the first half of 2026, Chinese innovative drug companies completed 81 out-licensing transactions, with a total potential value of approximately $110 billion——already reaching about 80% of the full-year 2025 total. Chinese companies claimed 8 of the top 10 global biopharma out-licensing deals.

But the market is shifting from "expectations" to "delivery." According to third-party databases such as PharmaCube, disclosed upfront payments in H1 totaled $5-6.5 billion——less than 6% of the total potential deal value. Tian Lihui, a finance professor at Nankai University, noted that this cycle is fundamentally different from the 2019 pipeline-concept hype and the 2021 out-licensing narrative——the core difference is "delivery": pipelines are moving from R&D to approval, and partnerships are moving from letter-of-intent agreements to multinational pharma paying upfronts.

Leading companies are validating this logic with their earnings. BeiGene reported H1 revenue of RMB 22.22 billion, up 26.8% year-over-year, with net profit of RMB 3.27 billion, up 627.1% year-over-year. Innovent Biologics reported H1 product revenue exceeding RMB 8.2 billion, up over 55% year-over-year. CSPC Innovation recorded H1 net profit of RMB 1.18-1.36 billion, turning losses into profits——with two licensing deals with AstraZeneca this year totaling $450 million in upfront payments and a potential total deal value exceeding $20 billion. RemeGen reported H1 revenue of approximately RMB 5.85 billion, up 433% year-over-year, with net profit of approximately RMB 4.7 billion, achieving profitability.

Huang Hanyang, lead pharmaceutical analyst at Xingye Securities, stated that the sector is transitioning from "valuation-driven" to "earnings + globalization delivery-driven."

V. Multiple Factors Converging, Driving Upstream Custom Synthesis Demand

The series of events in mid-August——three innovative drug approvals in one week, the AI pharma NewCo model landing, continued GLP-1 data emergence, and the $110 billion BD wave entering the earnings delivery test phase——together point to one signal: the multiple drivers of the innovative drug industry are firing simultaneously, and the industry is moving from "concept validation" to "earnings delivery."

More innovative drugs entering commercialization stages translate into sustained demand for high-purity intermediates, chiral building blocks, and complex heterocyclic compounds——in both volume and complexity. As AI pharma moves from single-molecule development to systematic pipeline incubation, the new targets and molecules identified by AI ultimately need to return to the lab——they require real compounds for validation.

VI. Beixinke Chem's Perspective

As a custom synthesis service provider based in Shanghai, specializing in inhibitor small molecules, heterocyclic intermediates, and chiral building blocks, Beixinke Chem is witnessing the real-world transmission of this industry shift upstream.

From our front-line experience: since the beginning of 2026, we have seen a noticeable increase in inquiries for new product development. Compared to 2025, demand for custom synthesis from labs and research organizations is accelerating——with requirements that are more specific, more concrete, and more urgent.

Our core capabilities cover the entire chain from retrosynthetic analysis to process scale-up: chiral construction, heterocyclic assembly, milligram-to-kilogram scale-up, and full HPLC/LC-MS/NMR analytical support. We have provided custom synthesis support to R&D labs and biotech companies both in China and internationally——across different scales and requirements.

If your R&D team is also tracking what this industry shift means for your supply chain, we would welcome the conversation.