YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 354 drug applications between 17 January 2026 and 23 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 47 drug names.
2026/01/17 – 2026/01/23
- New acceptances this week
- 354
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 87
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
354filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| New drug | 73 |
| Generic | 64 |
| Import | 38 |
| Unspecified | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| Therapeutic biologic | 84 |
| TCM | 59 |
| Biologic | 3 |
| In vitro diagnostic reagent | 1 |
| Prophylactic biologic | 1 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 6 | 3 | 84 |
| 2 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 3 | Nimodipine Oral Solution | 2 | 1 | 4 |
| 4 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 2 | 1 | 12 |
| 5 | Phenylephrine Hydrochloride Injection | 2 | 1 | 5 |
| 6 | Bromhexine Hydrochloride Oral Solution | 2 | 1 | 22 |
| 7 | Ziprasidone Hydrochloride Capsules | 2 | 1 | 9 |
| 8 | 维立西呱片 · No verified English name | 2 | 1 | 8 |
| 9 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 10 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 12 | 1 | 0 |
| 2 | Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized | 9 | 7 | 0 |
| 3 | Kashima Plant Eisai Co. Ltd. | 6 | 6 | 0 |
| 4 | Pfizer Inc. | 6 | 3 | 0 |
| 5 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 4 | 4 | 1 |
| 8 | F. Hoffmann-La Roche Ltd | 4 | 3 | 0 |
| 9 | Amgen Inc. | 4 | 2 | 0 |
| 10 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
126 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/23Import · Class 1 | PF-08634404 · No verified English nameJXSL2600024 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/01/23Import · Class 1 | PF-08634404 · No verified English nameJXSL2600023 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/01/23Import · Class 1 | Bleximenib片 · No verified English nameJXHL2600029 | Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2026/01/23Import · Class 1 | Bleximenib片 · No verified English nameJXHL2600028 | Stichting Hemato-Oncologie voor Volwassenen Nederland; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2026/01/23Import · Class 1 | HTT227片 · No verified English nameJXHL2600027 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/23Generic · Class 3 | Piracetam InjectionCYHS2600266 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized |
| 2026/01/23Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2600259 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2026/01/23Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2600258 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2026/01/23New drug · Class 1.1 | 丹元糖痹软膏 · No verified English nameCXZL2600012 | Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2026/01/23New drug · Class 1.1 | 十味安神颗粒 · No verified English nameCXZL2600011 | Hebei Ping An Health Group Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | 注射用GFS784 · No verified English nameCXSL2600124 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2600123 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2600122 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | D-2570片 · No verified English nameCXHL2600111 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | RP903片 · No verified English nameCXHL2600110 | Jun Shi Run Jia (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/23New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2600109 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/01/23New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2600108 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | ETD-001凝胶 · No verified English nameCXHL2600107 | Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | ETD-001凝胶 · No verified English nameCXHL2600106 | Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | ETD-001凝胶 · No verified English nameCXHL2600105 | Wuxi Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/01/23New drug · Class 1 | BC-006注射液 · No verified English nameCXHL2600104 | Bei Si Ke (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/01/22Import · Class 2.2 | 马塔西单抗注射液 · No verified English nameJXSS2600005 | Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd. |
| 2026/01/22Import · Class 2.4 | LOU064片 · No verified English nameJXHL2600026 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/22Import · Class 2.4 | LOU064片 · No verified English nameJXHL2600025 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/22Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600256 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600255 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Nimodipine Oral SolutionCYHS2600251 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/01/22Generic · Class 3 | Nimodipine Oral SolutionCYHS2600250 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.1 | 参灵颗粒 · No verified English nameCXZL2600010 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2026/01/22New drug · Class 1.2 | 障复康胶囊 · No verified English nameCXZL2600009 | Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized |
96 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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