Today's Pharma News: BI, GSK, Bayer, Lilly and Others Announce Key Pipeline and Partnership Updates

May 07, 2026 17:24 CST Updated 17:24

Ribo Life Science

Small Nucleic Acid Drug Developer

Huahai Pharmaceutical

Medical and Health Product Provider

Huaota

Biological New Drug Developer

On May 6, Ribo Life Science announced the achievement of the third key milestone in its siRNA collaboration with Boehringer Ingelheim (BI) in the field of Metabolic Dysfunction-Associated Steatohepatitis (MASH).

This progress marks a continued deepening of the collaborative R&D process between the two parties, and represents a solid step forward in the translational application of siRNA technology in the field of metabolic liver diseases. MASH is a severe progressive fatty liver disease, with over 200 million patients worldwide, and there is an urgent clinical need for innovative therapies that can slow disease progression. Dr. Gan Liming, Co-CEO of Ribo Life Science, stated that this milestone demonstrates the company's technical maturity in siRNA drug discovery and liver-targeted delivery. siRNA therapy achieves gene silencing by targeting the mRNA of disease-causing genes, and Ribo’s liver-targeting technology enables selective uptake by hepatocytes, acting on targets that are difficult to reach with traditional small molecules or antibodies. This collaboration further solidifies Ribo's position as a strategic partner for global pharmaceutical companies.

On April 29, Huahai Pharmaceutical issued an announcement, proposing to convert its RMB 2 billion debt held into equity for its subsidiary Huaota, increasing capital by subscribing to approximately RMB 183 million in new registered capital.

After the capital increase is completed, Huahai Pharmaceutical's direct shareholding ratio in Huaota will increase from 79.69% to 87.07%. Based on the transaction price, Huaota’s valuation before this debt-to-equity swap was approximately 3.5 billion yuan. The agreement stipulates that the total number of Huaota shares will be changed to approximately 503 million shares. Huahai Pharmaceutical will subscribe with its held 2 billion yuan principal amount of debt evaluated at 2 billion yuan, of which approximately 183 million yuan will be counted as registered capital and the remaining approximately 1.817 billion yuan will be counted as capital reserves. Both parties will complete the delivery within two working days after the agreement takes effect and complete the industrial and commercial change registration within 30 days from the delivery date. This move aims to optimize Huaota's capital structure and pave the way for its subsequent independent listing.

On April 30, Merck disclosed in its Q1 2026 financial report that its oral PCSK9 inhibitor Enlicitide (MK-0616) had been submitted for marketing authorization application in the EU for the treatment of primary hypercholesterolemia or mixed dyslipidemia.

This drug is an important asset in Merck's cardiometabolic pipeline and is currently in the regulatory review phase in the United States. Merck has classified it as a “cardiometabolic drug under regulatory review,” highlighting the company’s expectations for the product’s approval in major global markets. If the oral PCSK9 inhibitor successfully reaches the market, it will break the current monopoly of injectable formulations for this target, offering a more convenient treatment option for patients requiring long-term lipid-lowering therapy.

Selection,有望 reshape the lipid-lowering drug market landscape.

4. On May 1, 2026, the ninth batch of intelligent supervision rules issued by the National Medical Security Administration will be officially implemented.

A total of 601 detailed knowledge points for the new rule "Medications Restricted to Second-Line Use" were added. Combined with the "two high-level" interpretations issued on the same day — "Several Issues Regarding the Application of Law in Handling Criminal Cases of Embezzlement and Bribery (II)" — this creates a dual lock on doctors' prescription behavior through "big data + criminal law." The new medical insurance regulations strictly restrict 110 medications (including major products like DS-8201), allowing medical insurance payment only after "first-line treatment is ineffective or intolerable." The intelligent monitoring system preemptively intercepts off-label use and medications exceeding treatment lines. On the criminal side, pharmaceutical representatives’ "bribery-included sales" are explicitly criminalized, and the threshold for doctors being prosecuted for accepting bribes has been lowered to 30,000 yuan, significantly increasing risks associated with traditional gray-area benefits such as lecture fees and consulting fees. This combination aims to fully control the prescription pen and purify the healthcare market environment.

On May 6, Vigor Bio announced that its partner Dianthus Therapeutics (NASDAQ: DNTH) had selected Sjögren's syndrome (SjD), systemic lupus erythematosus (SLE), and dermatomyositis (DM) as the first set of prioritized indications for the bispecific fusion protein LBL-047 (DNTH212).

LBL-047 Targets BDCA2/TACI, Demonstrating First-in-Class and Best-in-Class Potential, Exerting Therapeutic Effects by Depleting pDC Cells to Reduce Type I Interferon and Inhibiting the BAFF/APRIL Signaling Pathway. Dianthus Secured Approximately $719 Million in Financing in March 2026 to Support Its Global Development. Currently, the Phase I Study of LBL-047 Conducted in China (Including Healthy Volunteers and SLE Patients) Was Initiated in December 2025, with Topline Data from Healthy Volunteers Expected to Be Released in the Second Half of 2026.

On May 1, Summit Therapeutics announced the interim analysis results of the global pivotal Phase III study, Harmoni-3, for its PD-1×VEGF bispecific antibody ivonescimab (依沃西单抗), which was licensed from Akeso Biopharma.

Data shows that in the squamous non-small cell lung cancer (NSCLC) cohort, the progression-free survival (PFS) of Yivoxelizumab did not reach the pre-set statistically significant endpoint. This negative result directly led to a single-day plunge of over 25% in Summit's stock price, casting a shadow over the global commercial prospects of this once highly anticipated star bispecific antibody. The Harmoni-3 study aims to evaluate the efficacy and safety of Yivoxelizumab in this population, and the failure to meet the endpoint in this interim analysis means that its path to market in key regions such as the United States will face significant uncertainty.

On May 6, Libang Pharmaceuticals announced that the global Phase III pivotal multi-regional clinical trial (RESPOND-2) of its novel oral iron-based phosphate binder AP301 has completed enrollment of all 282 patients.

The trial was conducted simultaneously in the United States (138 cases) and China (144 cases) as a double-blind, randomized, multi-regional study aimed at evaluating the efficacy and safety of AP301 in chronic kidney disease (CKD) patients undergoing dialysis with hyperphosphatemia. AP301 is a next-generation phosphate binder based on fiber-iron, designed to emphasize high phosphate binding capacity, good gastrointestinal tolerance, and low risk of iron overload, and can be swallowed without chewing. Ablon Pharma has reached an agreement with the FDA that this Phase III trial will serve as the single pivotal study supporting AP301's registration and market approval in the United States.

On May 5, Impella Pharma launched its Hong Kong IPO subscription, with an expected listing on May 13, potentially becoming "the first Hong Kong-listed synthetic lethal oncology drug stock."

The company boasts an impressive lineup of cornerstone investors, including Tencent and Lilly Asia Ventures. InnoPax Pharma is one of the few enterprises globally that owns both a commercial-stage PARP1/2 inhibitor (Senaparib) and a clinical-stage next-generation PARP1 selective inhibitor, with extensive investments in multiple synthetic lethality targets such as ATR and WEE1. The market potential for the synthetic lethality field is vast, with the global market size for PARP inhibitors estimated at approximately $4.3 billion in 2024, projected to exceed $6.9 billion by 2029. The listing of InnoPax Pharma marks a deep recognition by the capital markets of the precision cancer-fighting mechanism of synthetic lethality.

9. Lilly recently announced that it will acquire Kelonia Therapeutics for approximately $7 billion (with an upfront payment of $3.25 billion), setting a new record for acquisitions in the in vivo CAR-T field.

Kelonia's core asset, KLN-1010, is an in vivo CAR-T therapy targeting BCMA for the treatment of relapsed/refractory multiple myeloma. The Phase I data presented at AACR2026 showed that all four evaluable patients achieved minimal residual disease (MRD)-negative status. With this high-value acquisition, Eli Lilly aims to secure a leading position in the in vivo CAR-T technology field. Competition in this area is intensifying, with giants like Novartis and Bristol-Myers Squibb having already made strategic acquisitions. In vivo CAR-T therapy seeks to directly generate CAR-T cells within the body through intravenous injection, offering the potential to address the complex manufacturing and high costs associated with traditional CAR-T therapies.

10.On May 6, 2026, Shi’an Biologics announced an exclusive licensing agreement with GlaxoSmithKline (GSK) for the potential "first-in-class" siRNA drug SA030.

According to the agreement, Shian Biotech granted GSK the global exclusive rights to SA030 outside mainland China, Hong Kong, Macao, and Taiwan. SA030 targets ALK7 (Activin Receptor-Like Kinase 7) and is used for treating cardiometabolic diseases by reducing visceral fat, improving insulin sensitivity, and optimizing lipid profiles. It has recently entered Phase I clinical trials. Preclinical data show its long-acting effects and fat-targeting delivery characteristics, with the potential to be combined with GLP-1 and SGLT2 inhibitors to address residual cardiometabolic risks. This deal highlights the global competitiveness of Chinese companies in extrahepatic siRNA delivery technology.

11. Shuimu Molecule (incubated by the Institute for AI Industry Research of Tsinghua University) is entering the AI pharmaceuticals track through a dual-mode approach of "tool empowerment + self-developed pipeline."

The company's chief scientist, Professor Nie Zaicheng (former head of Alibaba AILab), led the development of core tools such as the ChatDD intelligent agent framework and the OpenBioMed open-source platform. It is estimated that by 2026, the global AI pharmaceuticals market will reach $2.99 billion, with particularly rapid growth in China. Shuimu Molecular’s strategy is to reduce drug discovery costs and improve efficiency through large models and intelligent agent technologies, while also developing its own pipeline and seeking breakthroughs in AI technology exports and pipeline licensing. In-depth collaborations between multinational pharmaceutical companies and tech giants (such as NVIDIA's partnership with MNCs) are driving AI pharmaceuticals to become another direction for China's pharmaceutical industry going global, following biologics.

12. Axsome Therapeutics announced that the FDA has approved the expanded indication for its drug Auvelity (dextromethorphan/bupropion combination) to treat agitation associated with Alzheimer's disease.

Auvelity is the first non-antipsychotic drug approved for this indication, targeting NMDA receptors and sigma-1 receptors. The approval was based on two Phase III studies (ADVANCE-1, ACCORD-2), which showed significant improvement in agitation symptoms (CMAI score) and Clinical Global Impression (mADCS-CGIC). Agitation affects approximately 76% of Alzheimer's patients, and there was previously a lack of safe and effective non-antipsychotic drugs. Following this news, Axsome's stock price surged over 20%.

13. Eli Lilly's Q1 2026 financial report shows total revenue of $19.799 billion, a year-over-year increase of 56%; net profit (non-GAAP) was $7.663 billion, a year-over-year increase of 155%.

Core product Tirzepatide generated over $12.8 billion in revenue in a single quarter, continuing to lead the metabolic disease market. Revenue in China reached $693 million, a 52% year-over-year increase, making it one of Eli Lilly's fastest-growing regional markets globally. Eli Lilly invested $3.51 billion (+28%) in R&D, further strengthening the development of key pipelines such as GLP-1 and Alzheimer’s disease. The strong earnings growth was primarily driven by the global scaling of products like Tirzepatide and Dulaglutide.

14. Bayer Announces Acquisition Agreement with Perfuse Therapeutics for $2.45 Billion to Fully Acquire the Company and Obtain All Rights to Its Core Asset PER-001

PER-001 is a small molecule endothelin receptor antagonist in Phase II clinical trials, used for the treatment of glaucoma and diabetic retinopathy (DR). Clinical data shows that it can improve the visual field of glaucoma patients and alleviate retinal ischemia symptoms in DR patients. Glaucoma and DR are major blinding eye diseases globally, with large patient populations (approximately 57.5 million for glaucoma and about 103 million for DR). Through this acquisition, Bayer strengthens its position in the field of innovative ophthalmic treatments.

References: Publicly available information on the Internet, including news articles, official company websites, and government documents.

Highlights:

April Pharma Executive Changes: Major Adjustments at Novartis, Pfizer, AZ, and Frequent Movements at Fosun, KPC, and HARBOR

Baldness Saved! Still Oral

New Policy Implemented on May 1st, Cell Therapy Welcomes New Order

Sales Suspended! China's National Medical Products Administration Cracks Down on Quality Management Systems

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