YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 397 drug applications between 18 April 2026 and 24 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 60 drug names.
2026/04/18 – 2026/04/24
- New acceptances this week
- 397
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 110
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
397filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 227 |
| Generic | 71 |
| New drug | 68 |
| Unspecified | 12 |
| Import re-registration | 12 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 137 |
| Therapeutic biologic | 45 |
| Biologic | 10 |
| Prophylactic biologic | 2 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿布昔替尼片 · No verified English name | 3 | 1 | 12 |
| 2 | 头孢丙烯干混悬剂 · No verified English name | 2 | 1 | 2 |
| 3 | Brexpiprazole Orally Disintegrating Tablets | 2 | 1 | 10 |
| 4 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 5 | 盐酸氢吗啡酮片 · No verified English name | 2 | 1 | 0 |
| 6 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 7 | Amlodipine Besylate Tablets | 2 | 1 | 8 |
| 8 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 1 | 5 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Ketoprofen Patches | 2 | 1 | 7 |
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
249 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 7 | 3 | 0 |
| 2 | Xinjiang Wei Wu Er Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 5 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Fuzhou Min Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 4 | 4 | 0 |
| 9 | Bayer AG | 4 | 3 | 0 |
| 10 | Shandong Bo An Bio Technology Co., Ltd. romanized | 4 | 3 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/24Import · Class 2.1 | Tarlatamab(皮下注射) · No verified English nameJXSL2600102 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
| 2026/04/24Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2600958 | Anhui Sheng Ying Pharma Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | 米诺地尔泡沫剂(男用) · No verified English nameCYHS2600956 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2600955 | Hebei Ke Yuan Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | Ferrous Succinate TabletsCYHS2600954 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2600947 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | Diprophylline InjectionCYHS2600944 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | Domiphen bromide Buccal TabletsCYHS2600940 | Name not romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized |
| 2026/04/24Generic · Class 3 | 盐酸奥昔布宁洗剂 · No verified English nameCYHL2600056 | Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2026/04/24New drug · Class 1.2 | 筋骨草总环烯醚萜苷片 · No verified English nameCXZS2600021 | Beijing Kang Chen Pharma Co., Ltd. romanized; Liaoning Wo Hua Kang Chen Pharmaceuticals Co., Ltd. romanized |
| 2026/04/24New drug · Class 1.2 | 筋骨草总环烯醚萜苷 · No verified English nameCXZS2600020 | Liaoning Wo Hua Kang Chen Pharmaceuticals Co., Ltd. romanized |
| 2026/04/24New drug · Class 2.2 | 艾帕洛利托沃瑞利单抗注射液 · No verified English nameCXSS2600072 | Qilu Pharmaceutical Co., Ltd. |
| 2026/04/24New drug · Class 3.2 | 人血管性血友病因子 · No verified English nameCXSL2600442 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2026/04/24New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2600441 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2600440 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | BA1106注射液 · No verified English nameCXSL2600439 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | BPR-30160639注射液 · No verified English nameCXHL2600503 | Chengdu Bei Te Rui Ma Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | 伊匹乌肽雾化吸入溶液 · No verified English nameCXHL2600499 | Guangzhou Yi Ming Kang Bio Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | BIOS0629-109片 · No verified English nameCXHL2600498 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | BIOS0629-109片 · No verified English nameCXHL2600497 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | HS-20136-2注射液 · No verified English nameCXHL2600491 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | HS-20136-2注射液 · No verified English nameCXHL2600490 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | HS-20136-2注射液 · No verified English nameCXHL2600489 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/24New drug · Class 1 | HS-20136-2注射液 · No verified English nameCXHL2600488 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/23Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSS2600040 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2026/04/23Import · Class 1 | Denikitug · No verified English nameJXSL2600101 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/04/23Import · Class 1 | Denikitug · No verified English nameJXSL2600100 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/04/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2600937 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2026/04/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2600936 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2026/04/23Generic · Class 3 | Drotaverine Hydrochloride TabletsCYHS2600928 | Jiangxi Yi You Pharma Co., Ltd. romanized |
72 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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