YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 242 drug applications between 7 September 2021 and 13 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 23 drug names.
2021/09/07 – 2021/09/13
- New acceptances this week
- 242
- Drugs with new generic filings (by drug name, de-duplicated)
- 23
- 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
242filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 35 |
| New drug | 33 |
| Import | 11 |
| Unspecified | 10 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| TCM | 38 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 7 |
| 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
23 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 2 | 10 |
| 2 | Carfilzomib For Injection | 3 | 1 | 0 |
| 3 | 烟酸缓释片 · No verified English name | 3 | 1 | 0 |
| 4 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 5 | Pitavastatin Calcium Tablets | 2 | 1 | 0 |
| 6 | Amisulpride Tablets | 2 | 1 | 0 |
| 7 | Lincomycin Injection | 2 | 1 | 1 |
| 8 | Milrinone Injection | 2 | 1 | 0 |
| 9 | Clotrimazole Vaginal Tablets | 1 | 1 | 3 |
| 10 | Rivaroxaban Tablets | 1 | 1 | 3 |
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
134 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 22 | 21 | 0 |
| 2 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Eli Lilly Nederland B.V. | 6 | 3 | 0 |
| 5 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 6 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 2 | 4 |
| 7 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 2 | 3 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Novo Nordisk A/S | 3 | 3 | 0 |
| 10 | Ji Chuan Pharma Group Co., Ltd. romanized | 3 | 3 | 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
53 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/13Import · Class 1 | IcoSema 注射液 · No verified English nameJXSL2101108 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2021/09/13Import · Class 1 | TPX-0022胶囊 · No verified English nameJXHL2101174 | Turning Point Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/09/13Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2101172 | Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd. |
| 2021/09/13Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2101715 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2021/09/13Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2101714 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2021/09/13Generic · Class 3 | 阿奇霉素颗粒(Ⅱ) · No verified English nameCYHS2101710 | Jiangxi Yi You Pharma Co., Ltd. romanized |
| 2021/09/13Generic · Class 3 | Milrinone InjectionCYHS2101702 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/09/13Generic · Class 3 | Milrinone InjectionCYHS2101701 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/09/13Generic · Class 3 | Citicoline Sodium InjectionCYHS2101682 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | JS012注射液 · No verified English nameCXSL2101324 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/13New drug · Class 3.2 | ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2101323 | Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | BGB-A445注射液 · No verified English nameCXSL2101322 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2101321 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | SHR-1909注射液 · No verified English nameCXSL2101320 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | HH-101注射液 · No verified English nameCXSL2101319 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2021/09/13New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2101318 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | CM336注射液 · No verified English nameCXSL2101317 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | BJ-001 注射液 · No verified English nameCXSL2101316 | Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101311 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101310 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | 普乐登赛 · No verified English nameCXSL2101309 | Shanghai Hui Dun Bio Technology Co., Ltd. romanized |
| 2021/09/13New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101471 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/09/13New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101470 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | 苹果酸法米替尼胶囊 · No verified English nameCXHL2101469 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/13New drug · Class 2.2 | 制霉菌素凝胶 · No verified English nameCXHL2101468 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | AND019胶囊 · No verified English nameCXHL2101467 | Hangzhou An Dao Pharma Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | AND019胶囊 · No verified English nameCXHL2101466 | Hangzhou An Dao Pharma Co., Ltd. romanized |
| 2021/09/13New drug · Class 2.2 | 西罗莫司滴眼液 · No verified English nameCXHL2101465 | Fuzhou Hao Ji Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | MT2004胶囊 · No verified English nameCXHL2101464 | Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/13New drug · Class 1 | MT2004胶囊 · No verified English nameCXHL2101463 | Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized |
23 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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