YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 396 drug applications between 13 September 2021 and 19 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 39 drug names.
2021/09/13 – 2021/09/19
- New acceptances this week
- 396
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- 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
396filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 224 |
| Generic | 61 |
| New drug | 55 |
| Import | 24 |
| Unspecified | 20 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| Therapeutic biologic | 51 |
| TCM | 41 |
| Prophylactic biologic | 11 |
| Biologic | 7 |
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 | Milrinone Injection | 3 | 2 | 0 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | 2 | 2 | 3 |
| 5 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 6 | Tedizolid Phosphate For Injection | 2 | 2 | 3 |
| 7 | Pitavastatin Calcium Tablets | 2 | 1 | 0 |
| 8 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 1 | 10 |
| 9 | Salbutamol Sulfate Inhalation Solution | 2 | 1 | 2 |
| 10 | Nilotinib Capsules | 2 | 1 | 6 |
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
222 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 Zhang Lian Du Lei Pharmaceutical Co., Ltd. romanized | 15 | 12 | 0 |
| 3 | Bristol-Myers Squibb Pharma EEIG | 11 | 2 | 0 |
| 4 | Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized | 10 | 10 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Sai Ling Pharma Technology Group Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Sun Pharmaceutical Industries Ltd. | 5 | 2 | 0 |
| 10 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/09/18Import · Class 1.1 | 预防性呼吸道合胞病毒疫苗 · No verified English nameJXSL2101111 | Janssen Vaccines & Prevention B.V.; Johnson & Johnson (China) Investment Ltd. |
| 2021/09/18Generic · Class 3 | Tranexamic Acid InjectionCYHS2101760 | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/09/18New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101335 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/18New drug · Class 1 | YY-20394片 · No verified English nameCXHL2101490 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2021/09/18New drug · Class 1 | ABM-1310胶囊 · No verified English nameCXHL2101489 | Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/18New drug · Class 1 | ABM-1310胶囊 · No verified English nameCXHL2101488 | Bi Chen (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/17Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2101180 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/09/17New drug · Class 2.2 | 注射用重组葡激酶 · No verified English nameCXSL2101333 | Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized |
| 2021/09/17New drug · Class 1 | SHR-2002注射液 · No verified English nameCXSL2101331 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/09/17New drug · Class 3.3 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2101326 | Shanghai Rong Sheng Bio Pharma Co., Ltd. romanized |
| 2021/09/17New drug · Class 2.2; 2.3 | 替格瑞洛阿司匹林胶囊 · No verified English nameCXHL2101487 | Le Pu Pharma Co., Ltd. romanized |
| 2021/09/17New drug · Class 1 | 注射用APG-1252 · No verified English nameCXHL2101486 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2021/09/17New drug · Class 1 | 富马酸BGB-10188胶囊 · No verified English nameCXHL2101482 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/09/17New drug · Class 1 | 富马酸BGB-10188胶囊 · No verified English nameCXHL2101481 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/09/16Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSS2101022 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/09/16Import · Class 1 | BCX9930片 · No verified English nameJXHL2101178 | BioCryst Pharmaceuticals Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/09/16Generic · Class 3 | 利奈唑胺氯化钠注射液 · No verified English nameCYHS2101747 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2021/09/16Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101726 | Chongqing Jian Neng Pharmaceuticals Kai Fa Co., Ltd. romanized; Sichuan Jian Neng Pharmaceutical Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSS2101030 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | TG103注射液 · No verified English nameCXSL2101330 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101329 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | ZG033注射液 · No verified English nameCXSL2101328 | Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized |
| 2021/09/16New drug · Class 2.2 | 注射用醋酸曲普瑞林微球 · No verified English nameCXHS2101039 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized |
| 2021/09/16New drug · Class 2.2 | 他达拉非口腔速溶膜 · No verified English nameCXHL2101485 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | IMP4297胶囊 · No verified English nameCXHL2101484 | Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized |
| 2021/09/16New drug · Class 1 | TT-01688-CL片 · No verified English nameCXHL2101483 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2021/09/15Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSS2101021 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/09/15Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101020 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/09/15Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101019 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/09/15Import · Class 2.2; 2.4 | 布地奈德缓释胶囊 · No verified English nameJXHL2101179 | EVEREST MEDICINES (SINGAPORE) PTE. LTD.; Everest Medicines (China) Co. Ltd |
55 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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