Novartis BTK Inhibitor Wins in Multiple Sclerosis; Nine Pharma Companies Strike U.S. MFN Pricing Deals

September 1, 2026 — In a week that reshaped multiple corners of the pharmaceutical industry, Novartis secured a major regulatory victory with its BTK inhibitor remibrutinib in multiple sclerosis, while nine drugmakers—including BeOne Medicines—struck pricing deals with the U.S. government that signal a fundamental shift in how global pharmaceutical prices are set.

The developments, spanning clinical trial successes, regulatory approvals, and strategic licensing deals, underscore a broader transformation: Chinese pharmaceutical companies are increasingly navigating both domestic policy shifts and international market pressures, even as the rules of engagement change beneath them.

Novartis BTK Inhibitor Wins in Multiple Sclerosis

On September 1, Novartis announced positive results from two Phase III studies—REMODEL-1 and REMODEL-2—evaluating remibrutinib in relapsing multiple sclerosis (RMS). The multicenter, randomized, double-blind trials enrolled nearly 2,000 RMS patients and compared remibrutinib 100mg against teriflunomide 14mg, with the primary endpoint being annualized relapse rate (ARR).

The results were decisive: remibrutinib demonstrated superiority over teriflunomide in reducing ARR and inflammatory brain lesions. In pooled analysis, 3-month confirmed disability progression (3mCDP) showed a trend toward reduction, while 6-month confirmed disability progression (6mCDP) was significantly lower in the remibrutinib group. Critically, no liver injury signal emerged—no patients reported serious drug-induced liver injury.

This safety profile is no small achievement. The BTK inhibitor class has been shadowed by hepatotoxicity concerns: Sanofi's tolebrutinib faced partial clinical holds from the FDA due to drug-induced liver injury, while Merck's evobrutinib failed to deliver compelling data. Novartis's emphasis on the absence of liver safety signals signals this was a key threshold for regulatory and clinical acceptance.

Remibrutinib, an oral covalent irreversible BTK inhibitor, first received FDA approval in September 2025 for chronic spontaneous urticaria. In the first half of 2026, global sales reached $101 million USD. The company plans to submit new indication applications globally. The core logic for BTK inhibitors in MS lies in their ability to cross the blood-brain barrier, simultaneously inhibiting peripheral B cells and central microglia—potentially offering advantages over anti-CD20 monoclonal antibodies that act only peripherally. The next question: in a landscape where high-efficacy anti-CD20 therapies like ocrelizumab dominate, can oral BTK inhibitors prove they don't just match but genuinely complement existing standards on hard endpoints like disability progression?

Nine Pharma Companies Strike U.S. MFN Pricing Deals

On August 31, the White House announced that the U.S. government had reached Most Favored Nation (MFN) pricing agreements with nine pharmaceutical companies, including BeOne Medicines. The other eight signatories—Alcon, Astellas, BridgeBio, CSL, Kyowa Kirin, Sun Pharmaceutical, Teva, and UCB—cover therapies for hemophilia, Parkinson's disease, macular degeneration, glaucoma, liver disease, dermatology, and various cancers.

Under the agreements, prescription drug prices will be reduced to the lowest level paid by other developed countries. The nine companies also committed to short-term combined investments of at least $19.6 billion USD in U.S. domestic manufacturing and will donate key active pharmaceutical ingredients to the Strategic Active Pharmaceutical Ingredient Reserve (SAPIR).

For BeOne, the calculus was straightforward. The company will provide tislelizumab at agreed prices through Medicaid, covering approximately 8% of the patient population across its approved U.S. indications. Tislelizumab (brand name BaiZeAn) is already approved in more than 50 markets globally, with 13 indications covered by China's National Medical Insurance. The 8% patient impact is limited; what BeOne gains is policy certainty and exemption from tariffs and pricing penalties—a classic small concession for market access stability.

To date, 26 companies have signed MFN agreements with the U.S. government, covering approximately 89% of the branded drug market. The implications extend far beyond individual deals: when the world's largest pharmaceutical market anchors prices to the lowest developed-country benchmark, multinational companies will inevitably offset losses by raising prices elsewhere or delaying launches in other markets. The global pricing reference system is being rewritten. For Chinese innovators eyeing U.S. expansion, the old narrative of "high-price U.S. launch first" may need revision.

Chia Tai Tianqing Licenses HER2 Bispecific ADC to Cipla

On August 31, Sino Biopharmaceutical announced that its subsidiary Chia Tai Tianqing had entered into an exclusive licensing and supply agreement with Indian pharmaceutical company Cipla for rolditamig deuderuxtecan (TQB2102), a self-developed HER2 bispecific antibody-drug conjugate (ADC). The deal grants Cipla exclusive development and commercialization rights in India, South Africa, and five other emerging markets—seven countries in total.

Financial terms: Chia Tai Tianqing is entitled to upfront payments plus development, regulatory, and sales milestone payments totaling up to $123 million USD, along with double-digit royalties on annual net sales. This marks the second regional licensing deal for TQB2102; the two collaborations have cumulatively generated approximately $30 million USD in upfront and milestone payments.

Cipla, founded in 1935, is India's third-largest pharmaceutical company and the second-largest prescription drug company in South Africa. TQB2102 has received three Breakthrough Therapy designations from China's Center for Drug Evaluation (CDE) and is advancing multiple Phase III studies in HER2-low breast cancer, HER2-positive breast cancer, colorectal cancer, and biliary cancer.

The deal reflects a strategic shift in Chinese biotech internationalization: rather than confronting Western markets head-on, companies are pursuing "regional licensing" models, targeting emerging markets where innovative drug accessibility lags far behind developed countries. India's regulatory approvals carry mutual recognition weight across South Asia, creating registration resource spillover. The pricing and reimbursement environment in these markets differs fundamentally from Europe and America—rather than compete directly with multinational giants on commercialization, Chinese companies can license rights to local partners while retaining production, supply, and royalty streams. This "rural encirclement" strategy deserves consideration from more Chinese biotechs.

2026 National Essential Drug List Takes Effect

On September 1, the 2026 edition of China's National Essential Drug List, comprising 794 drugs, officially took effect. According to statistics from Menet, a healthcare data provider, the 65 newly added Chinese patent medicines generated combined sales exceeding 16 billion RMB (approximately $2.2 billion USD) in China's public medical institutions in 2025.

Among the chemical drugs and biologics added, several blockbuster products crossed the 1-billion-RMB threshold: bevacizumab (including biosimilars) at 13.254 billion RMB ($1.83 billion USD), semaglutide injection at 6.473 billion RMB ($895 million USD), butylphthalide at 6.418 billion RMB ($888 million USD), and osimertinib at 5.840 billion RMB ($808 million USD).

Essential drug status means enhanced requirements for availability and use at primary and county-level medical institutions, opening channels for volume growth at the grassroots level. The structural signal is significant: essential drugs have long been synonymous with "old, cheap medications," but now high-priced targeted therapies and metabolic drugs like bevacizumab, osimertinib, and semaglutide are being included. The boundary of "basic coverage" is shifting upward, driven by medical insurance fund capacity and clinical value assessment. For pharmaceutical companies, essential drug status is the most effective market access pass for primary and county-level markets; over the next two years, county-level volume growth is likely to become a key variable in performance increments. For multinational companies with originator products, the challenge is direct competition with biosimilars and domestic innovative drugs on the same essential drug list.

Hengrui's SHR-A1811 Achieves Phase III Success in First-Line Breast Cancer

On August 31, Hengrui Medicine announced that its subsidiary Suzhou Shengdia's HER2 ADC ruikang trastuzumab (SHR-A1811) achieved the primary endpoint in a key Phase III study (SHR-A1811-307) for first-line treatment of HER2-positive recurrent or metastatic breast cancer. The prespecified interim analysis showed that both experimental arms—SHR-A1811 with or without pertuzumab—met the primary endpoint of progression-free survival (PFS), demonstrating statistically significant and clinically meaningful improvements compared to the THP regimen (docetaxel plus trastuzumab plus pertuzumab).

The study was co-led by Professor Jiang Zefei of the Fifth Medical Center of PLA General Hospital and Professor Yin Yongmei of Jiangsu Provincial People's Hospital, with participation from 75 centers nationwide and 868 enrolled patients. The company will soon submit a pre-NDA communication application to CDE.

The THP regimen has been the undisputed first-line gold standard for HER2-positive breast cancer for over a decade, never shaken. The fact that a domestic ADC achieved positive results with a dual-arm design—both with and without pertuzumab—means it could rewrite the first-line treatment landscape. Particularly notable is the arm without pertuzumab: if it can demonstrate equivalent efficacy without dual anti-HER2 blockade, patient quality of life and treatment costs would be redefined. Ruikang trastuzumab has already secured multiple later-line indications in lung cancer, breast cancer, and colorectal cancer; the push from later lines to first-line represents the most critical leap in value realization for domestic ADCs. Drawing from DS-8201's experience in rewriting HER2 breast cancer treatment pathways globally, this leap will determine whether it can reach the 10-billion-RMB scale. The next milestones to watch: overall survival data and the final combination regimen choice.

Bangshun Pharma Files for Second Hong Kong IPO

On August 30, Hangzhou Bangshun Pharmaceutical (BIOSUN PHARMA) submitted its listing application to the Hong Kong Stock Exchange Main Board, with CLSA International as sole sponsor, seeking to list under Chapter 18A. This marks the company's second attempt after its initial filing on January 22, 2026, expired.

The company's core product bezekxitinib, a selective JAK2 inhibitor, received NMPA approval in April 2026 for myelofibrosis. In a key Phase II/III study of 128 patients, the 24-week SVR35 rate was 62.8%, compared to 14.3% for the control arm hydroxyurea. Another core product, CX1440 (a BTK inhibitor), is in registration-stage clinical trials targeting ITP, chronic urticaria, and autoimmune hemolytic anemia.

Bangshun exemplifies the typical dilemma facing 18A companies: having an approval doesn't mean having revenue. The myelofibrosis track already includes ruxolitinib, gicaxitinib, and rovacitinib—with the latter two either already in medical insurance or newly approved this year. Bezekxitinib, as the fourth entrant, lacks first-mover advantage and medical insurance coverage; commercialization is the real test. More pressing is time pressure: with 183 million RMB ($25.3 million USD) in cash against annual losses approaching 300 million RMB ($41.5 million USD), an IPO has shifted from a "choice" to a "necessity." The real question: can this biotech—founded by veteran pharmaceutical entrepreneurs who quickly built capabilities through asset transfers—prove it has sustainable output capacity, rather than just securing approvals?

FDA Approves Besremi for Essential Thrombocythemia

On August 31, the FDA approved PharmaEssentia's long-acting interferon Besremi (ropeginterferon alfa-2b-njft) for adult essential thrombocythemia (ET), with a PDUFA target date of August 30. The pivotal Phase III SURPASS-ET study (n=174) showed that the ropeginterferon group achieved a modified ELN response rate of 42.9%, compared to just 6.0% for the control arm anagrelide (p=0.0001). In the Phase IIb EXCEED-ET study, response rates at months 10 and 13 were approximately 60.2%.

The U.S. has approximately 170,000 ET patients. First-line treatment consists of off-label hydroxyurea use, while second-line anagrelide was approved in 1997—meaning no new drugs had been approved for this indication in over two decades. Besremi was previously approved by the FDA in November 2021 for polycythemia vera and is currently approved for this indication in approximately 50 countries and regions globally.

This represents a textbook victory for "old drug, new use plus long-acting modification." Interferons have been used in myeloproliferative neoplasms for decades, but traditional formulations required weekly injections with poor tolerability. PEGylation technology alone extended the dosing interval to once every two weeks, effectively pushing an old mechanism back through FDA review. The approval logic is instructive: the FDA accepted "head-to-head defeat of anagrelide" rather than "superiority over hydroxyurea," suggesting that in rare diseases, regulators prioritize providing real options for drug-resistant/intolerant populations rather than displacing first-line standards. For domestic JAK2 inhibitors clustered in the myelofibrosis track, this is a reminder: the mechanistic advantages of long-acting interferons may prove more competitive in moderate-to-low risk populations.

Novavax XFG Variant COVID Vaccine Approved in US, EU, Japan

On August 31, Novavax's partners Sanofi and Takeda have sequentially received approvals from U.S., European Union, and Japanese regulators for the XFG variant-adjusted Nuvaxovid protein vaccine for the 2026-2027 vaccination season. Nuvaxovid is a recombinant protein-based (non-mRNA) COVID-19 vaccine; Novavax licenses external partners for commercialization, maintaining licensing revenue without building its own commercial infrastructure.

In the contraction cycle as COVID vaccines transition from public health products to routine seasonal vaccinations, Novavax has chosen a "de-commercialization, retain technology licensing" survival path—handing production and sales to partners like Sanofi and Takeda with global registration and channel capabilities, collecting seasonal licensing royalties. This is clear-eyed strategic contraction, a pragmatic solution for mid-sized vaccine companies facing mRNA giant pressure. The technology route retains value judgment: protein vaccines lack the flexibility of mRNA in variant update speed, but still have markets in safety reputation and cold chain conditions. After virus circulation stabilizes, the "sufficient and gentle" route may yet have its place.

CSPC Innovation Initiates Phase I of Amylin Receptor Agonist

On August 31, CSPC Innovation announced that its subsidiary Jushi Biologics has initiated a Phase I clinical trial for SYH2092 injection. SYH2092 is an amylin receptor agonist; through optimized agonist activity and fatty acid modification, it aims to improve efficacy while maintaining tolerable safety, delivering sustained weight loss benefits. The product received NMPA clinical trial approval in August 2026. The Phase I trial evaluates safety, tolerability, pharmacokinetics, and pharmacodynamics following single-dose administration in healthy participants, with future applications in obesity weight management and glycemic control in adult Type 2 diabetes patients.

Amylin represents the second validated metabolic pathway after GLP-1—it delays gastric emptying and produces central satiety effects, complementing GLP-1 mechanisms. Industry consensus widely expects "GLP-1 plus amylin" combination therapies to take the next baton (Novo Nordisk's CagriSema and Eli Lilly's eloralintide are both advancing). CSPC's entry timing isn't early, but the pathway is pragmatic: first validate single-drug safety and pharmacodynamic characteristics in Phase I, then pursue combination development. The real suspense lies in the time gap: when multinational companies' combination regimens have advanced to Phase III, the window for domestic followers may only be the narrow path of "cost and compliance."

Gilantai's Class 1 Nuclear Drug Receives Clinical Approval

On September 1, Beijing Gilantai Pharma announced that its self-developed Class 1 innovative therapeutic nuclear drug 177Lu-JLT003 injection received clinical trial approval from CDE, intended for treatment of integrin αvβ3-positive malignant tumors. Integrin αvβ3 is highly expressed on neovasculature and tumor cell surfaces in various solid tumors but shows low expression in normal tissues, making it a popular target for nuclear drug "theranostics" (combined therapy and diagnostics). China's nuclear drug track has continued heating up recently, with multiple lutetium-177 and actinium-225 labeled drugs entering clinical stages.

The competitiveness of nuclear drugs lies not just in targets, but in the "ligand-nuclide-supply chain" linkage. Alpha-v-beta-3 (RGD target) is not a novel target; imaging agent development saw multiple attempts in earlier years. Its current application in therapeutic nuclear drugs essentially represents "old target, new use" after maturation of nuclide supply and conjugation technology. But the real threshold for this track lies in the backend: lutetium-177's production capacity and half-life constraints, radioactive drug delivery radius limitations, and the number of hospitals qualified for nuclide therapy collectively determine how large a product can grow. As domestic players cluster into this space, whoever first builds out the supply chain and market access network may matter more than whoever has the newest target.

This article is based on pharmaceutical industry news from August 31 to September 1, 2026. All financial data has been verified against original sources. Currency conversions are approximate and for reference only.