The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion on 17 September 2026 recommending EU marketing authorization for Gevalka (ensartinib), an ALK inhibitor for advanced non-small cell lung cancer. The application came from Xcovery Holdings, a Florida-based drug developer that is now, per its parent's own disclosure, a wholly owned subsidiary of Betta Pharmaceuticals, a Hangzhou biopharmaceutical company listed on the Shenzhen Stock Exchange.
Twelve years from a minority stake to a subsidiary
Ensartinib's road from a joint venture to a CHMP opinion
- 2003
Betta Pharmaceuticals founded
Ding Lieming co-founds the Hangzhou company, which would go on to develop icotinib, the first domestically developed targeted anticancer drug approved in China.
- October 2014
Betta invests in Xcovery
Betta takes its first stake in the Florida-based drug developer to jointly advance X-396, the ALK inhibitor that would become ensartinib.
- 26 July 2017
Betta becomes controlling shareholder
A purchase of Xcovery's preferred shares gives Betta control of the company developing ensartinib outside China.
- 2020
First China approval
China's NMPA approves ensartinib for previously treated ALK-positive NSCLC, under the brand Besnna.
- 22 March 2022
China first-line expansion
NMPA expands the approval to first-line ALK-positive NSCLC, based on the eXalt3 trial.
- 18 December 2024
U.S. FDA approval
FDA approves ensartinib as Ensacove for ALK-inhibitor-naive, ALK-positive locally advanced or metastatic NSCLC.
- 8 July 2026
ELEVATE published in NEJM
A Phase 3 adjuvant trial of ensartinib after surgery shows an 80% reduction in risk of recurrence or death versus placebo.
- 17 September 2026
CHMP positive opinion
The committee recommends EU marketing authorization for Gevalka, now Xcovery Holdings' third major regulatory filing to clear.
- Ahead
European Commission decision
Typically due within about 67 days of a CHMP opinion, placing a decision around late November 2026.
Two patient populations, one opinion
A CHMP positive opinion is a scientific recommendation to the European Commission, not a marketing authorization in itself — the Commission's decision, which almost always follows the committee's recommendation, is what actually grants the right to sell a medicine across the EU. What distinguishes this opinion is its breadth: CHMP's recommendation for Gevalka covers adults with ALK-positive advanced NSCLC regardless of whether they have already been treated with an ALK inhibitor, a wider population than the FDA's December 2024 approval of the same drug in the United States, which is limited to patients who have not previously received one.
The EU filing itself illustrates how a non-European sponsor reaches the European market: Xcovery Holdings submitted the marketing authorization application, but SFL Pharmaceuticals Deutschland GmbH is named in EU records as the marketing authorisation holder — an EU-established entity acting on the application's behalf, a routine structure for a drug developed and owned outside the bloc.
“[Betta has] also begun filing for approval of such drugs in Europe, marking a significant milestone in the company’s international expansion.” Ding Lieming, Chairman and CEO, Betta Pharmaceuticals — 8 July 2026, discussing the company’s European filings alongside the ELEVATE trial’s NEJM publication
Ensartinib's case, in four numbers
Figures from the eXalt3 trial as reported at ensartinib's regulatory approvals in China and the United States, and EMA's standard post-opinion procedural timeline.
A kinase inhibitor that already beat its predecessor
Ensartinib is a second-generation ALK tyrosine kinase inhibitor, also active against ROS1 and several other kinases, designed to overcome the resistance mutations and limited brain penetration that constrained crizotinib, the first ALK inhibitor most patients encounter. In eXalt3, ensartinib was tested directly against crizotinib rather than a placebo or an older regimen — a higher bar than several of its predecessors faced at their own first approvals — and won on both overall and intracranial response.
What Gevalka brings that a first opinion doesn't usually have
A head-to-head win, not a single-arm study
eXalt3 randomized ensartinib against crizotinib directly, rather than measuring it alone against no defined comparator, the design regulators in China, the U.S. and now the EU have each reviewed.
Brain metastases addressed head-on
A 63.6% confirmed intracranial response rate, roughly three times crizotinib's 21.1%, matters directly for ALK-positive NSCLC, where brain metastases are common.
Two approvals already on the record
China's NMPA and the U.S. FDA have both already reviewed and approved ensartinib, giving EU regulators two prior full assessments to weigh alongside their own.
$9.8 billion by 2032, four molecules deep already
Gevalka would not open a new category. Crizotinib, alectinib, brigatinib and lorlatinib have each already won EU marketing authorization for ALK-positive NSCLC, most of them years ago, and alectinib in particular has become the category's dominant seller. A fifth entrant competes less for a foothold in a new field than for a slice of prescribing decisions oncologists already have well-worn options for.
The ALK-positive treatment market Gevalka would enter
$4.7B → $9.8B
Global ALK-positive lung cancer treatment market, 2025 estimate to 2032 forecast, as estimated by Coherent Market Insights.
Sources: Coherent Market Insights, ALK Positive Lung Cancer Treatment Market Size & Trends
Regulatory News outlook
We expect ensartinib to take a modest but durable single-digit share of EU ALK-positive prescribing within its first two years on the market, drawing more from crizotinib's remaining share than from alectinib's entrenched position.
How we got here: Coherent Market Insights' forecast implies roughly $5.1 billion of category growth between 2025 and 2032; a fifth approved entrant capturing a low-to-mid single-digit share of that growth, consistent with how later entrants have performed against an established leader in comparable oncology categories, implies tens of millions of euros in annual EU sales within a few years of approval.
Gevalka against the ALK inhibitors already approved in the EU
| Product | Maker | Generation | EU status |
|---|---|---|---|
| Gevalka (ensartinib) | Xcovery Holdings / Betta Pharmaceuticals | Second-generation ALK/ROS1 inhibitor | CHMP positive opinion, 17 September 2026; EC decision pending |
| Xalkori (crizotinib) | Pfizer | First-generation ALK/ROS1 inhibitor | EU marketing authorization, 23 October 2012 |
| Alecensa (alectinib) | Roche | Second-generation ALK inhibitor | EU authorized 16 February 2017; first-line extension 18 December 2017 |
| Alunbrig (brigatinib) | Takeda | Second-generation ALK inhibitor | EU first-line approval, 6 April 2020 |
| Lorviqua (lorlatinib) | Pfizer | Third-generation ALK/ROS1 inhibitor | EU conditional marketing authorization, 6 May 2019 |
From EMA's own marketing-authorization records and each company's announcements; not a clinical comparison.
What sixty-seven days still has to decide
A CHMP positive opinion is the harder regulatory step; the European Commission's decision that follows almost never departs from the committee's recommendation, but it is the Commission's decision, not CHMP's, that legally authorizes Gevalka's sale. Betta has not announced pricing, reimbursement strategy or a commercial launch plan for any EU market, all of which are separate, country-by-country processes that begin only after Brussels acts.
- European Commission decision: typically follows a CHMP positive opinion within about 67 days, which would place a decision around late November 2026.
- Reimbursement, market by market: an EU marketing authorization does not set a price or secure reimbursement in any single member state; those negotiations happen separately, country by country, after authorization.
- The EU-holder structure: SFL Pharmaceuticals Deutschland GmbH is named as the marketing authorisation holder of record; Regulatory News could not independently confirm the precise legal terms of its relationship to Xcovery and Betta beyond the EU filing itself.
- A parent company's broader pipeline: Betta markets icotinib and bevacizumab in China and continues to study ensartinib in earlier-stage and adjuvant settings, including the ELEVATE trial published in July 2026.
Sources & further reading
- European Medicines Agency, “Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 14-17 September 2026.” ema.europa.eu
- Betta Pharmaceuticals, “Marketing Authorization Application for Ensartinib Hydrochloride Capsules Receives Positive Opinion from CHMP,” Shenzhen Stock Exchange disclosure, 18 September 2026 (via Futu News). news.futunn.com
- Medscape, “EMA Backs Three New Options in Lung and Ovarian Cancers,” 2026. medscape.com
- Citeline Pink Sheet, “Klygefa And Gevalka Edge Closer To EU Approval For gMG And Lung Cancer,” 2026. insights.citeline.com
- Xcovery Holdings, “FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC),” press release, 18 December 2024. businesswire.com
- Betta Pharmaceuticals, ensartinib (Besnna) product page. bettapharma.com
- Coherent Market Insights, ALK Positive Lung Cancer Treatment Market Size & Trends. coherentmarketinsights.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did CHMP recommend?
A positive opinion, adopted at its 14-17 September 2026 meeting, recommending that the European Commission grant marketing authorization for Gevalka (ensartinib) to treat adults with ALK-positive advanced non-small cell lung cancer — covering both patients who have not previously received an ALK inhibitor and those who have. A CHMP positive opinion is a recommendation, not a final approval; the European Commission's decision typically follows within about 67 days.
Who makes Gevalka?
Ensartinib was developed jointly by Xcovery Holdings, Inc., a U.S. company based in Palm Beach Gardens, Florida, and Betta Pharmaceuticals Co., Ltd., a Hangzhou, China biopharmaceutical company listed on the Shenzhen Stock Exchange (300558). Betta first invested in Xcovery in 2014, became its controlling shareholder in 2017, and Xcovery is now, per Betta's own September 2026 disclosure, a wholly owned subsidiary. The EU marketing authorization application was submitted by Xcovery; SFL Pharmaceuticals Deutschland GmbH is named as the EU marketing authorisation holder of record, a common arrangement for sponsors based outside the European Union.
Is ensartinib approved anywhere else?
Yes. China's National Medical Products Administration first approved it in 2020 for previously treated ALK-positive NSCLC and expanded that approval to first-line use in March 2022. The U.S. FDA approved it under the brand name Ensacove on 18 December 2024, for ALK-inhibitor-naive ALK-positive NSCLC.
What trial supports the CHMP opinion?
eXalt3, a Phase 3 trial of 290 patients randomized to ensartinib or crizotinib. Ensartinib showed a median progression-free survival of 25.8 months versus 12.7 months for crizotinib, and a confirmed intracranial response rate of 63.6% versus 21.1% in patients with brain metastases at baseline.
