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Concise biotech intelligence. Oncology, cell therapy, antibodies, ADCs, gene therapy, and early clinical signals. High signal, low noise.
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GSK paid $110 million in cash for a molecule that has never been given to a human being. Two days earlier Roche paid $75 million for another one. Both sellers are Chinese, and neither asset has a clinical trial behind it.
On September 3 HUTCHMED licensed HMPL-A830 to GSK. It is an anti-EGFR antibody carrying a selective KRAS small-molecule inhibitor as its payload, which the company calls a first-in-class KRAS-EGFR antibody-targeted therapy conjugate. GSK takes worldwide rights outside mainland China, Hong Kong, Macau and Taiwan, for $110 million upfront and up to $1.185 billion in milestones, plus tiered royalties. HUTCHMED runs the global Phase 1 itself, starting in the second half of this year under NCT07718581. GSK also took a right of first negotiation on one earlier-stage conjugate from the same platform.
I owe a correction on this. On Thursday I closed a post about KRAS G12D by calling Tyligand's preclinical EGFR-KRAS conjugate the one thing in its pipeline that nobody ahead of it was running. GSK had paid $110 million for that architecture seven days before I wrote it. The sentence was narrowly true about the KRAS G12D companies and wrong about the field.
The architecture deserves the attention. An antibody-drug conjugate delivers a cytotoxin and kills whatever it reaches. This delivers a signalling inhibitor instead, so the antibody does two jobs at once: it blocks EGFR, and it concentrates a KRAS drug inside cells that display the receptor. Every KRAS inhibitor outside G12C has run into the same wall, which is that the concentration the tumour needs is more than the rest of the patient will tolerate. HUTCHMED frames the gap as non-G12C disease and has not said which mutations the payload covers. That is the number to ask for before the Phase 1 reads out.
Two days before that, Roche licensed SIM0660 from Simcere Zaiming, the oncology arm of Simcere Pharmaceutical. It is a trispecific antibody that grips CD79a and CD19 on B cells and CD3 on T cells, aimed at patients who have already failed CD19 or CD20 therapy, and at B-cell autoimmune disease. Seventy-five million dollars upfront, up to $1.53 billion, global rights. Also preclinical.
So $185 million of Western cash went into two Chinese molecules in one week, neither of which has a human dose behind it. Preclinical assets used to be the part of a Chinese pipeline a buyer got thrown in with the package. They are now the thing being bought, which means the diligence sits on the platform and the chemistry rather than on a response rate, and the buyer is paying for a thesis it cannot yet check.
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Wolwo, a Chinese drugmaker whose main product is dust-mite allergy drops, now has clearance to test a stem cell therapy in sepsis.
The IND is on the CDE's implied-approval list: an umbilical cord MSC injection ("Type II") from its subsidiary Zhejiang Wolwo Stem Cell Technology, for sepsis and/or septic shock. Accepted 28 Jul, announced as cleared 11 Oct.
China had cleared 186 stem cell INDs by April and has approved one stem cell drug. No cell therapy is approved for sepsis in the US or EU. The IND is the easy step. Watch for a registered trial and its first patient.
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A once-daily oral PDE4 inhibitor beat Otezla head-to-head in a 607-patient Phase 3 run entirely in China.
Week 16, prifemilast 20 mg once daily vs apremilast 30 mg twice daily: PASI 75 64.6% vs 35.3%, sPGA 0/1 55.6% vs 31.3%. Serious AEs 4.0% vs 2.5%, AE discontinuations 2.0% vs 1.5%. Company-reported; Newsoara-sponsored across 60 Chinese sites (NCT07712731).
The molecule has crossed the Pacific twice. vTv Therapeutics licensed it as HPP737 to Shanghai's Newsoara in 2018 and expanded that licence to global rights in February for $20M upfront. Newsoara then licensed ex-Greater China to San Diego's cAMPfield, which launched in June on a $180M Series A.
vTv still holds up to about $115M in milestones plus royalties. Newsoara plans a China NDA by year-end; cAMPfield is taking the drug into UC and Crohn's.
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Viatris is buying Pacira for $36.50 a share in cash, about $1.65B in equity value. Exparel and Zilretta are what it is paying for. PCRX-201 is the part I'd watch.
PCRX-201 (enekinragene inzadenovec) is a high-capacity adenovirus carrying IL-1Ra behind an inflammation-switched promoter, injected into the knee. Phase 2 ASCEND Part A randomised about 45 patients to two doses or placebo. Pacira guided Part A topline before the end of 2026.
The most advanced knee-OA gene therapy is Kolon TissueGene's TG-C, a cell-based product. It missed both co-primaries in ACTiVION-II in July. Its last Phase 3, ACTiVION-I, has slipped from October to December while the company looks into a high placebo response.
Both readouts now land by year-end, one of them inside a Mylan–Upjohn company.
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TCGX has closed a $600M fund dedicated to Asian biotechs.
TCGX Asia Life Sciences Fund I was oversubscribed. It is a separate vehicle from the firm's US and Europe flagship funds, though it works closely with them, and TCGX is adding offices in Shanghai and Hong Kong to run it. The source is the firm's own release (7 Oct). It names no investors.
TCGX is a US-based crossover investor, in private and public biotechs. My read: the licence-in deal is no longer the only route for Western capital into Chinese assets. A US crossover firm now has dedicated money and local teams to invest across company stages.
Watch for the first disclosed deals, and whether the fund leads rounds or follows.
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ArriVent's FURVENT miss at 240mg comes down to who read the scans, and nearly all of the gap sits in the chemo arm.
Median PFS, blinded central review vs investigators:
Firmonertinib 240mg: 11.0 vs 11.1 months
160mg: 8.4 vs 8.3
Platinum-pemetrexed: 9.5 vs 7.1
The trial was open-label. Central review was the primary endpoint, and 240mg vs chemo came in at HR 0.75, p=0.0654. On investigator review the same comparison was HR 0.61. The 160mg arm missed on both reads.
Takeda's EXCLAIM-2 chemo arm ran 9.6 months by central review in the same first-line exon 20 setting, and mobocertinib only matched it (HR 1.04).
Allist sells the drug in China as furmonertinib and licensed ex-China rights to ArriVent in 2021. OS is immature; ArriVent says it is weighing its development path.
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China's drug regulator is proposing priority review for the TIL that skips high-dose IL-2.
Juncell's nolgileucel (GC101) appeared on CDE's proposed priority review list on 8 October. The objection window closes 14 October. Juncell is pre-IPO; it refiled for a Hong Kong listing in June.
The data behind it is MIZAR-003, an open-label, randomized pivotal Phase 2 in about 100 PD-1-failed melanoma patients at 25 Chinese centres. Company-reported at ASCO 2026: median PFS 4.3 vs 1.6 months on chemo (HR 0.43), ORR 42.0% vs 6.1%. OS is not mature.
A correction to my June post on GC101: I wrote that it needs neither chemo prep nor IL-2. Patients still get lymphodepletion first, which Juncell calls low-intensity, and the trial registry lists the PD-1 antibody sintilimab after the infusion. The no-IL-2 part was right.
That is the comparison that matters for Iovance. Amtagvi, the only FDA-approved TIL, needs cyclophosphamide-fludarabine lymphodepletion before infusion and high-dose IL-2 after it. GC101 swaps the IL-2 for a PD-1 antibody.
One caution: 81.8% of MIZAR-003 patients had acral or mucosal melanoma, the subtypes common in China and rare in the US.
The TIL to watch is the one that is easiest to give.
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Caribou had an FDA-aligned Phase 3 design for its off-the-shelf CD19 CAR-T. On Tuesday it said it is shelving the drug, and it has hired Wedbush to find a buyer or merger partner.
The trial was ANTLER-3: about 250 second-line large B-cell lymphoma patients who are transplant-ineligible and can't get autologous CAR-T, vispa-cel against investigator's choice, PFS as the primary endpoint. Behind it, the 27-patient Phase 1 subgroup that matches the pivotal dose and donor criteria, company-reported at EHA in June: 82% ORR, 67% CR, median PFS 17.1 months.
CEO Rachel Haurwitz pointed to the financing environment for allogeneic CAR-T. CB-011, the BCMA program in myeloma, goes too. Cash was $113.8M on 30 June. The 8-K puts severance and trial wind-down at $15M to $19M, before lease and impairment charges.
Cellectis walked away from its two allogeneic programs on 14 September, 22 days earlier.
Allogene is still funded: $423.6M on 30 June, runway guided into 2029. Its ALPHA3 randomizes MRD-positive patients after first-line lymphoma treatment to cema-cel or observation, with an interim EFS update due mid-2027.
In China, CARsgen said on 29 September it had dosed the first patient in its NMPA-cleared Phase 1 of CT1190B, an off-the-shelf CD19/CD20 CAR-T.
What to watch now: whether anyone buys vispa-cel with ANTLER-3 attached.
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Regend Therapeutics says patients in Hainan have paid RMB 150,000 a treatment for its lung stem cell therapy since late May 2025. That was before its placebo-controlled Phase 2 had finished.
REGEND001 is the patient's own airway basal stem cells, expanded and returned by bronchoscope. Regend told 36Kr in February it had charged for more than 140 treatments across COPD, interstitial lung disease and bronchiectasis in the Boao Lecheng pilot zone, which lets hospitals bill for cell therapies without NMPA approval. The COPD use there is registered as an open-label Phase 1/2 sponsored by Ruijin Hospital (NCT06946953).
The Phase 2 (NCT05638776) randomised 58 COPD patients against placebo, single-blind, and completed on 9 Jul 2025. Regend reported a significant DLCO gain over placebo at ERS 2025. No results are posted on the registry and I found no paper.
The confirmatory Phase 3 (NCT07828353) went up on 18 Sep: 102 patients, blinded, placebo-controlled, DLCO at week 52. Not yet recruiting, estimated start this month, primary completion September 2028.
In China's stem cell sector, the cash register can open before the controlled data arrive.
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JUST IN: The 2026 Nobel Prize in Physiology or Medicine goes to Karl Deisseroth, Peter Hegemann and Georg Nagel "for their discoveries concerning light-gated ion channels and optogenetics."
Before the announcement, our newsletter ran five picks: GLP-1, CAR-T, cGAS-STING, optogenetics and phase separation. One of five hit.
We also got two of the three names. Our third pick was Gero Miesenböck. Nagel and Hegemann showed in 2002–03 that channelrhodopsins from green algae are light-gated ion channels. Deisseroth put ChR2 into neurons in 2005.
🇩🇪 Both German laureates trained at the Max Planck Society. Hegemann did his PhD in Dieter Oesterhelt's lab at the MPI of Biochemistry in Martinsried, then ran his own group there until he moved to Regensburg in 1993. Nagel led a group at the MPI of Biophysics in Frankfurt from 1992 to 2004, which covers the years of the channelrhodopsin papers.
The CGT angle: optogenetics now has a gene therapy under FDA review. Nanoscope's MOGENRY is an AAV opsin injected into the eye for retinitis pigmentosa, and the FDA accepted its BLA on 9 Sep.
The other four picks stay on our list for 2027.
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BREAKING NEWS
The 2026 #NobelPrize in Physiology or Medicine has been awarded to Karl Deisseroth, Peter Hegemann and Georg Nagel “for their discoveries concerning light-gated ion channels and optogenetics.”
Novartis is paying $575 million upfront for Abogen's in-vivo mRNA T-cell engager, ABO2203.
Total milestones reach $7.2 billion, plus royalties. The target is CD19xCD3 for autoimmune indications, delivered via lipid nanoparticles to generate bispecific engagers directly inside the patient.
The deal validates in-vivo T-cell redirection as a direct threat to ex-vivo autologous CAR-T. By having the patient's own liver or immune cells produce the CD19 engager from synthetic mRNA, Novartis bypasses leukapheresis, viral vectors, and multi-week vein-to-vein turnarounds entirely.
Autologous cell therapy platforms pushing into lupus and sclerosis now face an incumbent willing to price in-vivo convenience at half a billion in cash before clinical proof of concept.
Watch Phase 1 PK/PD readouts to see whether transient mRNA expression can match the deep, reset-level B-cell depletion achieved by cellular infusion.
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The European Commission has revoked the approval it gave Hansoh's aumolertinib in February. Its decision says more than Hansoh's announcement does.
Hansoh (HKEX, 27 Sep) calls it procedural: its 2022 EU application "contextually referenced" Tagrisso results that were still under AstraZeneca's eight-year data protection, which expired in 2024, and the Commission acted without waiting for the outcome of AstraZeneca's annulment action (T-289/26).
The Commission's decision of 25 September says the dossier used Tagrisso's FLAURA data to extrapolate safety and efficacy from Asian to European patients, and that without FLAURA the file "did not provide an adequate and sufficient basis" for a positive benefit-risk. The approval was "unlawful from the outset". AstraZeneca is not mentioned; the EMA raised the issue on 9 July.
Aumolertinib has sold in China since 2020 and keeps its UK approval from June 2025. Hansoh had no EU sales, will resubmit on the original package, and says the EMA is willing to shorten the review. Tagrisso made $769M in Europe in H1 2026.
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China's Order 818 registry, list ten: five filings, and for the first time none is flagged as carried over from the old stem cell or somatic cell rules.
The list, posted on 22 September for filings of 16–21 September, covers China's hospital-filed route for new biomedical technologies such as cell therapy, which sits outside the NMPA's IND system. A missing flag is not proof a study is new.
One filing shows the two routes overlapping. The First Affiliated Hospital of Anhui Medical University filed a Parkinson's study of UX-DA003, UniXell's allogeneic iPSC-derived dopamine-neuron precursors. UniXell says the product already holds an NMPA IND (3 June) and an FDA IND (June).
So one product can carry a hospital filing in China alongside INDs in China and the US, and hospital-route data can surface apart from its registered trials.
List eleven, with nine more filings, went up on 30 September. I'm reading it next.
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JUST IN: Novartis will pay Abogen $575M upfront for ABO2203, a CD19×CD3 T-cell engager that is injected as mRNA and built by the patient's own cells. Milestones can reach about $7.2B if Novartis exercises every option on Abogen's other RNA programs. Exclusive worldwide rights; closing still needs regulatory clearances.
On 22 September I wrote up this drug's first autoimmune data, published in Cell: three women with refractory immune thrombocytopenia, all with complete platelet responses within a month that held at six months, no CRS, no ICANS, and no IND that I could find. Ten days later it has a buyer.
In late August Novartis paused all eight autoimmune trials of rap-cel, its autologous CD19 CAR-T, after three patients died of IEC-HS, a hyperinflammatory syndrome that sets in after CRS has passed. BMS disclosed a pause of its own autoimmune CD19 CAR-T the same week. Neither has announced a restart.
ABO2203 takes the cell out. Abogen's lipid nanoparticles go under the skin, whatever cells take them up make the bispecific, and the protein has a half-life of 7 to 11 days in patients, so it is dosed weekly and can be stopped. Across nine lymphoma patients at AACR and the three ITP patients in Cell there was no CRS and no ICANS; the paper's 16 autoimmune patients had nothing worse than grade 2. Both are Ruijin Hospital studies, and Abogen co-funded and co-wrote the Cell paper. Small numbers, nothing yet past six months.
Novartis's president of biomedical research, Fiona Marshall, says the approach could complement existing modalities. The price says where it sits. Gilead agreed in March to pay $1.675B upfront for Ouro's BCMA×CD3 protein engager, and UCB in May $2B upfront for Candid's, both early-stage assets that also trace to Chinese companies. Novartis is paying about a third of that or less, for fewer patients and options on more programs from the same platform.
What to watch: whether Novartis moves ABO2203 into a company-sponsored trial under an IND, since both trials so far are the hospital's, and what the Cell patients' platelets do now that their B cells have returned, which happened at month four or five. Novartis has not said when rap-cel's autoimmune trials resume.
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Beam has sued YolTech, the Shanghai base-editing company whose AATD drug Serapha licensed in June, alleging trade-secret misappropriation. Serapha is a co-defendant. The case was filed on 25 September in Massachusetts federal court under the Defend Trade Secrets Act.
Beam alleges that a former Beam scientist founded YolTech while still working at Beam, then filed patent applications for YolTech based on Beam's confidential information. Serapha "categorically refutes" the claims; YolTech says it built its technology through its own research.
The asset is Serapha's lead program, SERP-01, which makes the same single-letter DNA correction as Beam's BEAM-302. Serapha's reverse merger into Nasdaq-listed Boundless Bio is expected to close in Q4, with $230M of financing ($92M of it due at closing), and would leave Boundless holders with 3.69%.
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9 of 10 responses and 9 of 10 MRD-negative in relapsed or refractory myeloma, with no lymphodepleting chemo. That is IASO Bio's in-vivo BCMA CAR-T, IASO206, from a Chinese investigator-initiated study shown last week.
The benchmark is KLN-1010, the in-vivo BCMA CAR-T Lilly got when it paid $3.25B upfront for Kelonia.
IASO206, a late-breaking oral at the International Myeloma Society meeting: 10 patients over three dose levels, 3 stringent CRs. MRD threshold not disclosed; the one MRD-positive patient was at the lowest dose. No ICANS, CRS grade 2 at most, two grade 3+ viral infections, both resolved. Company-reported, follow-up not disclosed.
KLN-1010 at EHA in June: 18 of 18 responses. All 14 tested at one month were MRD-negative at 10⁻⁵. Two ICANS cases, one grade 3. Median follow-up 2.8 months.
Ten patients against eighteen, in different trials. The next read is durability, and whether IASO takes IASO206 to the FDA the way it took its CD20 in-vivo CAR-T, IASO208, cleared for a US trial in September on data from a Chinese hospital study.
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Roche's GYMINDA trial had one primary endpoint: percent change in body weight at 48 weeks, with the myostatin antibody emugrobart or a placebo added to Lilly's tirzepatide.
On Monday, Chugai said an interim analysis showed the trial is unlikely to meet its prespecified goal of clinically meaningful weight loss. No new safety signals were seen. Roche has stopped development and is returning all rights to Chugai (TSE 4519), the Japanese drugmaker it majority-owns.
Weight is the number obesity drugs are approved on. Veru said last year that the FDA told it extra weight loss over a GLP-1 alone is an acceptable primary endpoint for approving its muscle-preserving add-on.
Roche has now dropped emugrobart in three indications this year. In March it stopped the spinal muscular atrophy and FSHD programs after the drug did not consistently improve muscle growth or function.
It is the second myostatin drug Roche has let go. The first, licensed from Bristol Myers Squibb, was stopped in Duchenne muscular dystrophy in 2019. Biohaven later licensed it from BMS as taldefgrobep alfa, and it missed its Phase 3 in SMA in 2024.
The myostatin antibody that got through is Scholar Rock's. On September 11 the FDA approved apitegromab, sold as Isembyld, for SMA patients aged 2 and older who are already on nusinersen or risdiplam. It is the first muscle-targeted SMA treatment, an IV infusion every four weeks, with a list price of $11,659 a vial and a net cost Scholar Rock puts at about $310,000 a year for a typical patient.
Chugai now wants to take emugrobart back into SMA against it. It cites subcutaneous dosing, the drug's safety and long-term data, and a redesigned Phase 3, and says it is exploring out-licensing to a third party.
Roche is still pursuing muscle in obesity, through a different pathway. In August it licensed Hanmi's HM17321, a urocortin 2 analog in Phase 1 meant to cut fat while sparing muscle, for $190 million upfront.
Scholar Rock has the SMA muscle market to itself for now. Chugai's route back starts with a Phase 3 that has not begun.
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53 days after announcing its NMPA IND, CARsgen says it has dosed the first patient in the China Phase 1 trial of CT1190B, its off-the-shelf CD19/CD20 CAR-T, in large B-cell lymphoma after two or more prior lines (HKEX, 29 Sep). No new data.
Behind it are hospital studies shown at EHA in June, company-reported: 11 of 12 evaluable patients responded, 8 with complete responses, across large B-cell and follicular lymphoma. One grade 3 CRS, one grade 3+ ICANS. 7 of 11 responders were still responding at a median follow-up of 6.6 months.
The product now moves from hospital studies into a company trial the regulator oversees, the route that can end in an approval filing.
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Tao Hu has now licensed two KRAS G12D inhibitors to big pharma, each before a single patient had been dosed.
The first went to AstraZeneca in November 2023, from Usynova, the company he ran then: $24 million upfront and up to $419 million in total. AstraZeneca took it into the clinic and dropped it in November 2025.
The second went to Merck on Monday, from SciBrunch, the Shanghai company he co-founded in late 2024. SPR2015 brought $400 million upfront and up to $2.13 billion in total, and the deal has already closed. SciBrunch had raised about $65 million before it. Merck will book the upfront as a third-quarter charge of about 13 cents a share.
That is more than 16 times the upfront for a molecule at the same stage. I think most of the difference is what Revolution Medicines has proved since 2023.
Revolution's drugs use a glue that binds a common cellular protein, cyclophilin A, and clamps it onto RAS in its active, ON state. In August the FDA approved its daraxonrasib in metastatic pancreatic cancer, after a Phase 3 in previously treated patients showed median overall survival of 13.2 months against 6.7 on chemotherapy. Its G12D-selective drug, zoldonrasib, has had Breakthrough designation in previously treated lung cancer since January, and in April it posted a 52% confirmed response rate in 27 such patients.
SciBrunch's molecule uses the same design. Its AACR abstract this spring shows SPR2015 binding cyclophilin A and bonding covalently to the G12D mutant, as zoldonrasib does. Usynova's molecule was a reversible inhibitor built on known KRAS scaffolds.
Merck tried to buy the original first, according to reports in January. In June I wrote that Revolution had flatly rejected a $32 billion Merck offer. That was wrong. The reporting said the two were in talks at $28 billion to $32 billion, and that Merck ended them when they could not agree on a price.
Revolution's G12D drug already has a response rate in patients. Merck's will get its first human data only after a Phase 1 that SciBrunch's abstract expected to start by the end of this year.
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Two CAR-Ts got the same verdict from South Korea's reimbursement committee this year, for the same third-line lymphoma patients. Only one is going ahead.
The verdict: eligible for coverage in adults with relapsed or refractory DLBCL or PMBCL after two or more lines, if the company accepts the agency's assessed price or a lower one. Gilead's Yescarta got it in May. Gilead turned it down and is now seeking coverage for second-line use instead.
Rimqarto, the first CAR-T developed in Korea, got the same verdict on September 3. Its maker, Curocell (KOSDAQ 372320), now has up to 60 days of price talks with the National Health Insurance Service and is aiming to be listed this year.
The only CAR-T covered today is Novartis's Kymriah, listed in 2022 at about 360 million won an infusion (roughly $265,000 at current rates), with the patient's share capped at about 6 million won at the time. Korean press expects Rimqarto's price to come in around Kymriah's or lower.
Korea's drug regulator, the MFDS, gave Curocell more than it asked for. Curocell filed for conditional approval, which would have left a Phase 3 to run after launch. The MFDS waived the Phase 3 and granted full approval in April. Its advisers called a randomized trial unethical, because proven CAR-Ts already exist, and impractical, because third-line patients are few.
Rimqarto is a CD19 CAR-T whose vector also dials down PD-1 and TIGIT, two brakes that build up on exhausted T cells. The approval rests on one single-arm Phase 2, where Curocell reports a 75.3% response rate and 67.1% complete responses. At the analysis presented in June 2025, with median follow-up of 8.5 months, grade 3 or worse CRS occurred in 8.9%, median progression-free survival was 6.0 months, and an estimated 41.1% were progression-free at a year.
The stock has fallen while Curocell waits. It was around 65,000 won when the approval came in April and about 25,000 after the committee verdict this month. Korean coverage blames the uncertain start of revenue and a thin pipeline behind Rimqarto; the next program, in lupus, was cleared for a Phase 1/2 trial in August 2025.
The homegrown drug has a Chinese-owned supplier. Curocell's lentiviral vector partner is ProBio, the contract manufacturing arm of Nanjing-based GenScript. ProBio says its plant is the first lentiviral vector facility to receive GMP certification from Korea's drug regulator.
Kymriah has had Korea's CAR-T reimbursement list to itself since 2022. By next year it could share third-line lymphoma with a CAR-T made in Daejeon, while Gilead tries for second line.
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AbbVie got its first approval from the $8.7 billion Cerevel deal on Friday: tavapadon, a once-daily Parkinson's pill it will sell as Juvmo.
The deal was known for a different drug. Emraclidine, for schizophrenia, failed both Phase 2 EMPOWER trials in November 2024. AbbVie's shares opened 12% lower that day, and the company later took a $4.5 billion pre-tax write-down ($3.5 billion after tax). AbbVie started a new Phase 2 in schizophrenia in August 2025.
Tavapadon has had three owners. Pfizer discovered it as PF-06649751, put it into Cerevel with Bain Capital in 2018, and collected about $1.2 billion for its Cerevel stake when AbbVie bought the company.
The new part is the receptor. Pramipexole and ropinirole, the most widely used dopamine agonists, act on D2 and D3, and their labels warn of hallucinations and impulse-control problems. Tavapadon is a partial agonist at D1 and D5 and barely binds D2 or D3. It is the first Parkinson's drug built that way.
Abbott, the company AbbVie was spun out of in 2013, took a D1 agonist called adrogolide into Parkinson's trials in the 1990s. At most 4% of an oral dose reached the bloodstream, its half-life was three to four hours, and development stopped in 2001. Tavapadon's half-life is about 24 hours.
Efficacy held up in Phase 3. In TEMPO-1, 529 patients with early disease, the combined motor score (MDS-UPDRS II+III) improved 9.7 and 10.2 points on the two doses at week 26, while placebo worsened by 1.8. Added to levodopa in TEMPO-3, 507 patients, it gave 1.1 more hours a day of "on" time without troublesome dyskinesia than placebo.
The trade-off is in the dropout numbers. About 18% of TEMPO-1 patients on drug stopped for adverse events, against 4% on placebo; in TEMPO-3 it was 17.1% against 9.1%. In TEMPO-1, 6.2% of patients on the 15 mg dose had hallucinations and no one on placebo did, while impulse-control events stayed at 1% or less. No TEMPO trial compared it with pramipexole or ropinirole, so whether it beats them on those side effects is untested.
That puts the weight on price. In early Parkinson's, Juvmo competes with generic levodopa, pramipexole and ropinirole, and AbbVie has not disclosed what it will charge.
It is the first Cerevel asset that can start earning back the $8.7 billion. The list price is the number I'm watching.
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