YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 8 June 2022 and 14 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 32 drug names.
2022/06/08 – 2022/06/14
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- Accepted this week, now under review
- 0
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
361filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 213 |
| Generic | 50 |
| New drug | 47 |
| Import | 31 |
| Import re-registration | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| Therapeutic biologic | 68 |
| TCM | 43 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Atomoxetine Hydrochloride Capsules | 7 | 1 | 6 |
| 2 | Olanzapine Tablets | 3 | 1 | 4 |
| 3 | Olmesartan Medoxomil Tablets | 2 | 1 | 1 |
| 4 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 5 | Pregabalin Capsules | 2 | 1 | 12 |
| 6 | Pantoprazole Enteric-Coated Tablets | 2 | 1 | 1 |
| 7 | Rasagiline Mesylate Tablets | 2 | 1 | 5 |
| 8 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 9 | Oseltamivir Phosphate For Oral Suspension | 2 | 1 | 2 |
| 10 | Minoxidil Topical Solution | 2 | 1 | 0 |
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
180 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 23 | 20 | 0 |
| 2 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized | 11 | 4 | 0 |
| 3 | Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 7 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 8 | 2 | 8 |
| 6 | F. Hoffmann-La Roche Ltd | 7 | 4 | 0 |
| 7 | Novo Nordisk A/S | 7 | 3 | 0 |
| 8 | Guangxi Ji Min Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Jiangxi Na Fu Tang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/14Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2200085 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2022/06/14Import · Class 2.2 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200146 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Import · Class 2.2; 2.4 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200145 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Import · Class 2.2; 2.4 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200144 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2200883 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2022/06/14Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2200875 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2022/06/14Generic · Class 3 | Folic Acid TabletsCYHS2200860 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | BC007抗体注射液 · No verified English nameCXSL2200267 | Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | 注射用KJ103 · No verified English nameCXSL2200266 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2200265 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | 注射用BAT8008 · No verified English nameCXSL2200263 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2022/06/14New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2200386 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/06/14New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2200385 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/06/14New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2200384 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/06/14New drug · Class 1 | TCIC-001颗粒 · No verified English nameCXHL2200383 | Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | TCIC-001颗粒 · No verified English nameCXHL2200382 | Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2200380 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/06/14New drug · Class 2.2 | 盐酸氨溴索口溶膜 · No verified English nameCXHL2200379 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/14New drug · Class 1 | QLH12007片 · No verified English nameCXHL2200378 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/13Import · Class 3.1 | 地舒单抗注射液 · No verified English nameJXSS2200019 | Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/06/13Import · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameJXSL2200084 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/06/13Import · Class 3.3 | 雷珠单抗注射液 · No verified English nameJXSL2200083 | Samsung Bioepis NL B.V.; Shanghai Affamed Therapeutics Co. Limited |
| 2022/06/13Import · Class 1 | RO7435846片 · No verified English nameJXHL2200143 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2022/06/13Import · Class 1 | RO7435846片 · No verified English nameJXHL2200142 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2022/06/13Import · Class 1 | RO7435846片 · No verified English nameJXHL2200141 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2022/06/13Generic · Class 3 | Venlafaxine Hydrochloride Extended Release TabletsCYHS2200865 | Hainan Hui Gu Pharma Co., Ltd. romanized |
| 2022/06/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200864 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/06/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200863 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/06/13Generic · Class 3 | Minoxidil Topical SolutionCYHS2200862 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2022/06/13Generic · Class 3 | Minoxidil Topical SolutionCYHS2200861 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
56 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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