YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 284 drug applications between 23 May 2022 and 29 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 40 drug names.
2022/05/23 – 2022/05/29
- New acceptances this week
- 284
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
284filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| Generic | 57 |
| New drug | 47 |
| Import | 27 |
| Unspecified | 13 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| Therapeutic biologic | 45 |
| TCM | 30 |
| Biologic | 7 |
| Prophylactic 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piperacillin Sodium for Injection | 5 | 2 | 16 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Epalrestat Tablets | 2 | 2 | 1 |
| 5 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 6 | Budesonide Nasal Spray | 2 | 1 | 3 |
| 7 | Lamotrigine Dispersible Tablets | 2 | 1 | 2 |
| 8 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 9 | Terbutaline Sulfate Injection | 2 | 1 | 2 |
| 10 | Mirabegron Extended-release Tablets | 2 | 1 | 1 |
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
161 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bo Zhou Ya Ying Pharmaceuticals Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Jiangxi Yuan Dong Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Novartis Pharma AG | 5 | 3 | 0 |
| 6 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 7 | Hainan Zan Bang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | ASPEN PHARMA TRADING LIMITED | 5 | 1 | 0 |
| 9 | Jilin Sheng Dou Bang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 3 | 1 |
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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/28Import · Class 3.1 | Netakimab注射液 · No verified English nameJXSL2200066 | Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/05/28Import · Class 2.2 | 二氟泼尼酯滴眼液 · No verified English nameJXHL2200123 | SUN PHARMACEUTICAL INDUSTRIES LTD. |
| 2022/05/28Import · Class 1 | Enpatoran · No verified English nameJXHL2200122 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2022/05/28Import · Class 1 | Enpatoran · No verified English nameJXHL2200121 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2022/05/28Generic · Class 3 | Epalrestat TabletsCYHS2200799 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | 伊基仑赛注射液 · No verified English nameCXSL2200234 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | 伊基仑赛注射液 · No verified English nameCXSL2200233 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | EOC202注射液 · No verified English nameCXSL2200232 | Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized |
| 2022/05/28New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2200341 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/28New drug · Class 2.2 | Enzalutamide TabletsCXHL2200339 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2022/05/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2200018 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2200017 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2200016 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/05/27Import · Class 1 | VAY736注射液 · No verified English nameJXSL2200067 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/05/27Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200790 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2022/05/27Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200789 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2022/05/27Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200783 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2022/05/27Generic · Class 3 | Epalrestat TabletsCYHS2200777 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/05/27Generic · Class 3 | Aripiprazole Oral SolutionCYHS2200776 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/05/27Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHL2200045 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/27Generic · Class 3 | Irbesartan and Amlodipine TabletsCYHL2200044 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/27New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2200054 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2022/05/27New drug · Class 1 | 泽美洛韦玛佐瑞韦单抗注射液 · No verified English nameCXSS2200053 | Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/05/27New drug · Class 1 | 泽美洛韦玛佐瑞韦单抗注射液 · No verified English nameCXSS2200052 | Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/05/27New drug · Class 3.2 | 外用重组人凝血酶 · No verified English nameCXSS2200051 | Name not romanized |
| 2022/05/27New drug · Class 1 | 赫基仑赛注射液 · No verified English nameCXSL2200231 | He Yuan Bio Technology (Tianjin) Co., Ltd. romanized |
| 2022/05/27New drug · Class 3.2 | 静注人免疫球蛋白 · No verified English nameCXSL2200230 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2022/05/27New drug · Class 3.2 | 静注人免疫球蛋白 · No verified English nameCXSL2200229 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2022/05/27New drug · Class 1 | B1962注射液 · No verified English nameCXSL2200226 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/27New drug · Class 1 | HR20014注射液 · No verified English nameCXSL2200225 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
57 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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