After the Phase II superior efficacy data for GenFleet Therapeutics-B's (02595) innovative candidate GFH375 was presented as an oral report at this year's WCLC conference on September 14, the drug's combination therapy with cetuximab was included in the domestic breakthrough therapy designation list on September 18. According to Zhitong Finance APP observations, under the catalyst of these major positive developments, the market reversed its previous "pre-unlock risk aversion" sentiment, which subsequently drove GenFleet Therapeutics' stock price gains.
The "V-shaped recovery" brought about by better-than-expected data. In fact, from August 26 to September 11, GenFleet Therapeutics' stock price underwent a one-way decline, falling nearly 20% over 13 trading days. The reasons were twofold: on one hand, the Hong Kong pharmaceutical sector experienced an overall correction during the same period, with the Hang Seng Healthcare Index dropping 6.59%; on the other hand, the company was facing an upcoming major shareholder lock-up expiration on September 19. Data showed that this unlock involved 235 million shares held by 47 shareholders of GenFleet Therapeutics, accounting for approximately 61.31% of total share capital, corresponding to an unlocked market value of up to HK$6.111 billion. Additionally, GenFleet Therapeutics experienced a stock depository anomaly on September 3, with total depository market value of HK$1.955 billion, representing 19.65%. As a result, the market at that time tended to price the company based on "uncertainty" until the disclosure of better-than-expected data for the company's core candidate at the WCLC conference on September 14.
According to Zhitong Finance APP, the oral report at this WCLC conference demonstrated GFH375's excellent efficacy in NSCLC patients at the 600 mg QD dose level, with nearly 100% of enrolled patients having distant metastases and over 40% having previously received two or more lines of treatment: as of the data cutoff date, 71 patients completed at least one post-treatment assessment, with an ORR of 59.2%, cORR of 52.1%, and DCR of 93%; moreover, patients who had not previously received taxanes achieved an mPFS of 9.6 months, and the 12-month overall survival rate for all patients was 77%. This data structure clearly exceeded previous market expectations. On September 17, BOCOM International stated in an updated research report that "compared with the Phase I results of key competitor RMC-9805, GFH375 achieved similar mPFS in patients with later treatment lines and similar prior medication history, with overall 12-month OS rate, ORR, and DCR either better than or basically consistent with the latter. Safety at the 600mg QD dose was generally manageable and consistent with previous reports, with no new safety signals identified." Accordingly, the firm raised its long-term global revenue forecast for GFH375, maintaining a buy rating on GenFleet Therapeutics with a target price of HK$51.
The emergence of this bellwether signal also quickly drove market sentiment. GenFleet Therapeutics' stock price went through a significant recovery from September 17 to October 7, with a maximum gain of 39.85% during the period. Particularly on September 21, GenFleet Therapeutics experienced a "massive volume long bullish candle" in the market: the company's stock price surged 13.75% that day; single-day stock turnover reached HK$993 million, corresponding to a turnover rate of 10.66%, with the company's daily trading volume and turnover reaching 27 times and 28.7 times the average of September 15-18, respectively. On the technical front, the September 21 surge directly initiated the repair and strengthening of GenFleet Therapeutics' subsequent moving averages and trends. Driven by positive market sentiment, GenFleet Therapeutics' stock price continued to climb, quickly recovering the 20-day, 30-day, and 60-day moving averages within the following 20 days, with short-term trend indicators shifting from weak repair to relatively strong. In terms of momentum indicators, the MACD golden cross repair during the same period, along with the strengthening of RSI/KDJ indicators, also signaled that on-market capital was重新 assigning a premium to GenFleet Therapeutics for its clinical catalysts.
Sector risk appetite cooling fails to mask market sentiment. Taking a longer time frame, GenFleet Therapeutics' stock price movement from September 17 to now has not been a one-way climb, but rather experienced a pullback from October 8 to 14. The reason lies in an industry event: the overseas Phase III clinical trial of furmonertinib failed to reach its primary endpoint, causing its overseas partner ArriVent's stock price to plummet nearly 47% in a single day. Under the impact of this negative event, the market directly downgraded the valuation of domestic innovative drugs going overseas, Phase III clinical success rates, and the probability of overseas milestone realization, completing a rapid logical shift from "pipeline imagination space" to "verifying real clinical delivery capability," which severely suppressed the AH innovative drug sector sentiment that day, with numerous unprofitable, high-valuation Biotech companies relying on future clinical data for pricing bearing the brunt, and GenFleet Therapeutics was one of them.
However, after the short-term pullback, GenFleet Therapeutics' stock price quickly rebounded after October 15, and what supported its stock price changes and on-market investor bullish sentiment were the announcements it successively published on September 23 and October 15. According to Zhitong Finance APP, on September 23, GenFleet Therapeutics announced that the company's clinical project GFH375 combined with cetuximab combination therapy was proposed by the Center for Drug Evaluation of the National Medical Products Administration on September 18, 2026, to be included in the breakthrough therapy designation (BTD) list for the treatment of KRAS G12D mutant metastatic colorectal cancer that has failed prior chemotherapy based on oxaliplatin, fluoropyrimidines, and irinotecan. Subsequently, the company further disclosed in a voluntary announcement on October 15: the combination with cetuximab achieved an ORR of 44%, DCR of 89%, and median PFS of 7.3 months in 54 treated CRC patients; among 24 treatment-naive pancreatic cancer patients, the ORR was 71% and DCR was 100%. At the same time, GenFleet Therapeutics also confirmed in the announcement that GFH375 has obtained three BTDs in China for pancreatic cancer, NSCLC, and colorectal cancer, and has entered two registrational Phase III trials for pancreatic cancer and NSCLC; overseas partner Verastem is expected to initiate the VS-7375 first-line pancreatic cancer Phase III trial by year-end, having reached consensus with the FDA on the protocol.
The positive progress of core innovative candidates also means that GenFleet's pricing anchor has expanded from "a single NSCLC later-line drug" to "a global pipeline advancing across multiple indications, monotherapy plus combinations, and both domestic and overseas tracks." In addition to the above factors, GenFleet Therapeutics' continued share buybacks are also an important reason supporting market confidence. According to Zhitong Finance APP data, since September 8, GenFleet Therapeutics has conducted 12 successive share buybacks, repurchasing 1.161 million shares involving HK$30.4356 million. Although the total number of shares repurchased in this round accounts for only 0.3% of the company's total share capital, with signaling significance outweighing actual buying force, the continued buybacks still convey the attitude that "the board believes the company's current stock price is still below intrinsic value," providing a management confidence foundation for GenFleet Therapeutics' continued value revaluation going forward.
In the announcement published on October 15, GenFleet Therapeutics mentioned that preliminary clinical research data for its pipeline product GFH276 (Pan RAS inhibitor) as monotherapy for RAS-mutant solid tumors has been selected as a Late-Breaking Abstract (LBA) for the 2026 European Society for Medical Oncology (ESMO) Annual Congress to be held in Madrid. According to Zhitong Finance APP, as an oral pan-RAS inhibitor, GFH276 adopts a CypA-GFH276-RAS tri-complex mechanism, covering KRAS G12C, G12D, G12V as well as NRAS, HRAS and other activated-state RAS proteins. Previous preclinical data showed that its potency, PK, and safety profile have differentiated advantages relative to RMC-6236, and it requires only about 1/3 of the dose to achieve comparable antitumor efficacy. Against the backdrop of further validation of the Pan-RAS drug RMC-6236 track value by Revolution Medicines in August this year, global pharmaceutical companies' attention to Pan-RAS has significantly increased, and some institutions believe this may bring higher premium expectations for GFH276's future overseas licensing negotiations. BOCOM International also explicitly listed GFH276's solid tumor data to be disclosed at the ESMO Annual Congress as a key catalyst for the company's subsequent stock price performance in its research report. Therefore, as another platform-type asset of GenFleet Therapeutics, if the key data disclosed by GFH276 at this ESMO Congress significantly exceeds expectations, it may usher in a new round of valuation upgrades going forward.
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