YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 344 drug applications between 7 January 2022 and 13 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 59 drug names.
2022/01/07 – 2022/01/13
- New acceptances this week
- 344
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
344filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 74 |
| New drug | 38 |
| Import | 30 |
| Unspecified | 9 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 261 |
| Therapeutic biologic | 40 |
| TCM | 36 |
| Biologic | 4 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 4 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 5 | Lenalidomide Capsules | 2 | 1 | 3 |
| 6 | Octreotide Acetate Microspheres for Injection | 2 | 1 | 0 |
| 7 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 9 | Dacomitinib Tablets | 2 | 1 | 0 |
| 10 | Febuxostat Tablets | 2 | 1 | 12 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized | 21 | 6 | 0 |
| 2 | Guangxi Kun Ze Pharma Co., Ltd. romanized | 15 | 2 | 0 |
| 3 | Hua Run Shuang He Pharma Co., Ltd. romanized | 11 | 9 | 0 |
| 4 | Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Jiangxi Jiu Hua Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 5 | 3 | 0 |
| 7 | LES LABORATOIRES SERVIER | 4 | 3 | 0 |
| 8 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 3 | 3 |
| 9 | NewAmsterdam Pharma B.V. | 4 | 2 | 0 |
| 10 | YaoPharma Co., Ltd. | 4 | 2 | 4 |
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 |
|---|---|---|
| 2022/01/13Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2200074 | Hebei Xin Rui Wei Lai Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/13Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200063 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2022/01/13Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2200031 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2022/01/13Generic · Class 3 | 磷酸奥司他韦干糖浆 · No verified English nameCYHS2200030 | Zhong Run Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2022/01/13New drug · Class 1.1 | 石榴花栓 · No verified English nameCXZL2200003 | Xinjiang Wei Wu Er Zi Zhi Qu Wei Wu Er Pharmaceuticals Research Institute romanized |
| 2022/01/13New drug · Class 1 | 葎草花粉点刺液 · No verified English nameCXSS2200004 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2022/01/13New drug · Class 2.2 | 注射用醋酸戈舍瑞林缓释微球 · No verified English nameCXHS2101059 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | SCR-6920胶囊 · No verified English nameCXHL2200020 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | SCR-6920胶囊 · No verified English nameCXHL2200019 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | SCR-6920胶囊 · No verified English nameCXHL2200018 | Jiangsu Xian Sheng Pharma Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | MAX-40279-01胶囊 · No verified English nameCXHL2200017 | Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | MAX-40279-01胶囊 · No verified English nameCXHL2200016 | Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/13New drug · Class 1 | LLT311202注射液 · No verified English nameCXHL2101862 | Beijing Le Pu Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Ao Da Bio Technology Co., Ltd. romanized |
| 2022/01/12Import · Class 1 | MK-7684A注射液 · No verified English nameJXSL2101154 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/01/12Import · Class 1 | MK-7684A注射液 · No verified English nameJXSL2101153 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/01/12Import · Class 2.4 | Finerenone TabletsJXHS2200014 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/01/12Import · Class 2.4 | Finerenone TabletsJXHS2200013 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/01/12Import · Class 1 | 177Lu-PSMA-617注射液 · No verified English nameJXHL2200014 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/01/12Import · Class 1 | 用于制备放射性药物68Ga-PSMA-11的PSMA-11药盒 · No verified English nameJXHL2200013 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/01/12Import · Class 1 | Belvarafenib Dihydrochloride · No verified English nameJXHL2200012 | F.Hoffmann-La Roche Ltd.; Roche (China) Holding Ltd. |
| 2022/01/12Generic · Class 3 | Flurbiprofen Axetil InjectionCYHS2200062 | Guangdong Jia Bo Pharmaceutical Co., Ltd. romanized |
| 2022/01/12Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2200054 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2022/01/12Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2200053 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2022/01/12Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2200010 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2022/01/12Generic · Class 3 | 双氯芬酸依泊胺贴 · No verified English nameCYHL2200006 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2022/01/12New drug · Class 3.3 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2200003 | Jiangsu Kang Run Bio Technology Co., Ltd. romanized |
| 2022/01/12New drug · Class 1 | JAB-BX102注射液 · No verified English nameCXSL2200017 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2022/01/12New drug · Class 3.3 | 14028注射液 · No verified English nameCXSL2200016 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2022/01/12New drug · Class 3.3 | 14028注射液 · No verified English nameCXSL2200015 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2022/01/12New drug · Class 1 | HH-009注射液 · No verified English nameCXSL2200014 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
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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