YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 315 drug applications between 28 June 2022 and 4 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 39 drug names.
2022/06/28 – 2022/07/04
- New acceptances this week
- 315
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- Accepted this week, now under review
- 1
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
315filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| New drug | 69 |
| Generic | 55 |
| Import | 25 |
| Import re-registration | 23 |
| Unspecified | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| Therapeutic biologic | 42 |
| TCM | 24 |
| Prophylactic biologic | 5 |
| 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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Urapidil Hydrochloride Injection | 4 | 2 | 6 |
| 2 | Tedizolid Phosphate Tablets | 3 | 3 | 1 |
| 3 | Levetiracetam extended-release tablets | 3 | 2 | 0 |
| 4 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 5 | Norepinephrine Bitartrate Injection | 2 | 2 | 9 |
| 6 | Levofloxacin Injection | 2 | 1 | 1 |
| 7 | Paliperidone Extend-release Tablets | 2 | 1 | 2 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | 盐酸多奈哌齐口崩片 · No verified English name | 2 | 1 | 0 |
| 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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer AG | 6 | 6 | 0 |
| 2 | Hebei Wu Luo Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Hubei Kang Wei Yuan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Ren He Yi Kang Group Co., Ltd. romanized | 6 | 4 | 0 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 6 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 8 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Novartis Pharma Schweiz AG | 4 | 1 | 0 |
| 10 | Pfizer Europe MA EEIG | 4 | 1 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/04Import · Class 1 | Cetrelimab · No verified English nameJXSL2200102 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/04Import · Class 1 | BN301 · No verified English nameJXSL2200101 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 1 | BN301 · No verified English nameJXSL2200100 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2200169 | AbbVie Inc. |
| 2022/07/04Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2200993 | Hua Run Sai Ke Pharma Co., Ltd. romanized |
| 2022/07/04Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2200992 | Hua Run Sai Ke Pharma Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2200471 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2200470 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | HE009片 · No verified English nameCXHL2200469 | Nanchang Hong Yi Pharma Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | HE009片 · No verified English nameCXHL2200468 | Nanchang Hong Yi Pharma Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | HE009片 · No verified English nameCXHL2200467 | Nanchang Hong Yi Pharma Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | BGB-15025片 · No verified English nameCXHL2200466 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameJXSL2200099 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameJXSL2200098 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2200095 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/02New drug · Class 1 | BA1106注射液 · No verified English nameCXSL2200307 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | LTC004 · No verified English nameCXSL2200306 | Beijing Zhi Dao Bio Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | 注射用低分子量岩藻糖化糖胺聚糖钠 · No verified English nameCXSL2200305 | Mu Dan Jiang You Bo Pharma Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | 靶向GPC3嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200304 | Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | AK119注射液 · No verified English nameCXSL2200296 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200463 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200462 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200461 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200460 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200459 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200458 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | EVER001胶囊 · No verified English nameCXHL2200454 | Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Nicergoline TabletsCYHS2200980 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/06/30Generic · Class 3 | Levofloxacin InjectionCYHS2200978 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Levofloxacin InjectionCYHS2200977 | Changchun Hai Yue Pharma Co., Ltd. romanized |
66 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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