YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 88 drug applications between 30 April 2022 and 6 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 11 drug names.
2022/04/30 – 2022/05/06
- New acceptances this week
- 88
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
88filings, 13 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 44 |
| Import | 16 |
| Generic | 13 |
| New drug | 12 |
| Unspecified | 2 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 60 |
| TCM | 16 |
| Therapeutic biologic | 8 |
| Prophylactic biologic | 4 |
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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Amisulpride Injection | 2 | 1 | 1 |
| 2 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 3 | Tinidazole Tablets | 1 | 1 | 0 |
| 4 | 氧(液态) · No verified English name | 1 | 1 | 13 |
| 5 | Dexrazoxane for Injection | 1 | 1 | 1 |
| 6 | Roxatidine Acetate Hydrochloride For Injection | 1 | 1 | 5 |
| 7 | Atomoxetine Hydrochloride Oral Solution | 1 | 1 | 0 |
| 8 | Ambroxol Hydrochloride Oral Solution | 1 | 1 | 46 |
| 9 | Sitagliptin Phosphate Tablets | 1 | 1 | 2 |
| 10 | Roxithromycin Tablets | 1 | 1 | 2 |
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
54 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | UNION therapeutics A/S | 6 | 2 | 0 |
| 2 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 4 | N.V. Organon | 4 | 1 | 0 |
| 5 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 6 | Pfizer Inc. | 3 | 2 | 0 |
| 7 | Beijing Lang Di Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Novo Nordisk A/S | 3 | 1 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Shenzhen Shi Xin Tai Pharmaceuticals Co., Ltd. romanized | 2 | 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
31 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/06Import · Class 1 | PF-06801591注射液 · No verified English nameJXSL2200054 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/05/06Import · Class 2.2 | Somapacitan注射液 · No verified English nameJXSL2200053 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/06Import · Class 2.2 | Somapacitan注射液 · No verified English nameJXSL2200052 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/06Import · Class 2.2 | Somapacitan注射液 · No verified English nameJXSL2200051 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/06Import · Class 1 | BMS-986166-04 胶囊 · No verified English nameJXHL2200104 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2022/05/06Import · Class 1 | PF-07265807片 · No verified English nameJXHL2200103 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/06Import · Class 1 | PF-07265807片 · No verified English nameJXHL2200102 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/06Import · Class 1 | SAR443820 · No verified English nameJXHL2200101 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2022/05/06Generic · Class 3 | Dexrazoxane for InjectionCYHS2200705 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2022/05/06Generic · Class 3 | Amisulpride InjectionCYHL2200041 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/05/06Generic · Class 3 | Amisulpride InjectionCYHL2200040 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/05/06New drug · Class 1 | 注射用重组人源化抗CD70单抗-AS269偶联物(ARX305) · No verified English nameCXSL2200196 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/06New drug · Class 1 | 注射用HRS-8427 · No verified English nameCXHL2200275 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/06New drug · Class 2.4 | A2022注射液 · No verified English nameCXHL2200274 | Beijing Pu De Kang Li Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2022/05/05Import · Class 1 | Orismilast 缓释片 · No verified English nameJXHL2200100 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200099 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200098 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast 缓释片 · No verified English nameJXHL2200097 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200096 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200095 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Generic · Class 3 | Tinidazole TabletsCYHS2200698 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/05/05Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2200696 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/05/05New drug · Class 1.1 | 参味宁郁片 · No verified English nameCXZS2200005 | Guangdong Si Ji Pharma Co., Ltd. romanized; Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | GZR4 · No verified English nameCXSL2200192 | Gan Li Pharma Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200022 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200021 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200020 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 2.2; 2.4 | BM201注射液 · No verified English nameCXHL2200273 | Suzhou Bai Mai Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | HS248片 · No verified English nameCXHL2200272 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | HS248片 · No verified English nameCXHL2200271 | Han Hui Pharmaceutical Co., Ltd. romanized |
1 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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