YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 288 drug applications between 29 August 2022 and 4 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 48 drug names.
2022/08/29 – 2022/09/04
- New acceptances this week
- 288
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- 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
288filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 136 |
| Generic | 61 |
| New drug | 44 |
| Import | 27 |
| Import re-registration | 12 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| Therapeutic biologic | 53 |
| TCM | 29 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 2 | Lornoxicam for Injection | 2 | 2 | 2 |
| 3 | Perampanel Tablets | 2 | 1 | 2 |
| 4 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 5 | Ornidazole Injection | 2 | 1 | 0 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 7 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Memantine Hydrochloride Oral Solution | 2 | 1 | 0 |
| 9 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 10 | Citicoline Injection | 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
167 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Roche Pharma (Schweiz) AG | 9 | 2 | 0 |
| 2 | Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Eli Lilly and Company | 7 | 2 | 0 |
| 4 | Janssen Research & Development LLC | 6 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Guangxi Sheng He Pharmaceutical Co., Ltd. romanized | 4 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/04New drug · Class 1 | AK0707胶囊 · No verified English nameCXHL2200647 | Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/04New drug · Class 1 | AK0707胶囊 · No verified English nameCXHL2200646 | Suzhou Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/03Import · Class 2.4 | INC280 · No verified English nameJXHL2200274 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/03Import · Class 2.4 | INC280 · No verified English nameJXHL2200273 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/09/03Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2200271 | Advanced Accelerator Applications USA Inc. A Novartis Company; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/09/03Generic · Class 3 | Mannitol-S InjectionCYHS2201452 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/09/03Generic · Class 3 | Ozagrel Sodium InjectionCYHS2201446 | Ben Xi Heng Kang Pharmaceutical Co., Ltd. romanized |
| 2022/09/03Generic · Class 3 | Ozagrel Sodium InjectionCYHS2201445 | Ben Xi Heng Kang Pharmaceutical Co., Ltd. romanized |
| 2022/09/03Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2201443 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Changzhou Pharmaceutical Factory Co., Ltd. romanized |
| 2022/09/03New drug · Class 1 | TC-N201注射液 · No verified English nameCXSL2200436 | Guangdong Tian Ke Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/02Import · Class 1 | BIIB059 · No verified English nameJXSL2200154 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/09/02Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2201442 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2022/09/02Generic · Class 3 | Methocarbamol InjectionCYHS2201436 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/09/02Generic · Class 3 | Ornidazole InjectionCYHS2201425 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2022/09/02Generic · Class 3 | Ornidazole InjectionCYHS2201424 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2022/09/02New drug · Class 1.1 | 芪黄明目胶囊 · No verified English nameCXZS2200007 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | 注射用ZW25 · No verified English nameCXSL2200435 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | 注射用ZW25 · No verified English nameCXSL2200434 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | 注射用QLF32101 · No verified English nameCXSL2200433 | Qilu Pharmaceutical Co., Ltd. |
| 2022/09/02New drug · Class 1 | GC304腺相关病毒注射液 · No verified English nameCXSL2200432 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | 注射用LM-305 · No verified English nameCXSL2200431 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | WS016干混悬剂 · No verified English nameCXHL2200645 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | IMG-004胶囊 · No verified English nameCXHL2200644 | Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | IMG-004胶囊 · No verified English nameCXHL2200643 | Ying Mai Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | ASC61片 · No verified English nameCXHL2200642 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/09/02New drug · Class 1 | PA9159吸入气雾剂 · No verified English nameCXHL2200641 | Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200153 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200152 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200151 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/09/01Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2200269 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
54 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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