YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 249 drug applications between 9 September 2021 and 15 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 26 drug names.
2021/09/09 – 2021/09/15
- New acceptances this week
- 249
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- 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
249filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 38 |
| New drug | 36 |
| Import | 16 |
| Unspecified | 9 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| Therapeutic biologic | 38 |
| TCM | 26 |
| Prophylactic biologic | 5 |
| 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
26 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 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Olmesartan Medoxomil and Hydrochlorothiazide Tablets | 2 | 2 | 3 |
| 4 | Pitavastatin Calcium Tablets | 2 | 1 | 0 |
| 5 | Ambroxol Hydrochloride Solution For Inhalation | 2 | 1 | 10 |
| 6 | Nilotinib Capsules | 2 | 1 | 6 |
| 7 | Amisulpride Tablets | 2 | 1 | 0 |
| 8 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
| 9 | Levocetirizine dihydrochloride Oral Solution | 2 | 1 | 5 |
| 10 | 磷酸奥司他韦干糖浆 · No verified English name | 2 | 1 | 0 |
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
142 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 22 | 21 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 10 | 2 | 0 |
| 3 | Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Eli Lilly Nederland B.V. | 4 | 3 | 0 |
| 7 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
| 9 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 2 | 3 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/09/15Generic · Class 3 | 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101735 | Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized |
| 2021/09/15Generic · Class 3 | 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101734 | Yang Zi Jiang Pharma Group Beijing Hai Yan Pharma Co., Ltd. romanized |
| 2021/09/15New drug · Class 3.4 | 冻干重组人脑利钠肽 · No verified English nameCXSL2101327 | Shijiazhuang Wo Tai Bio Technology Co., Ltd. romanized |
| 2021/09/15New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHS2101041 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/15New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHS2101040 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/09/15New drug · Class 1 | HZ-H08905片 · No verified English nameCXHL2101480 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2021/09/15New drug · Class 1 | 注射用HRS8179 · No verified English nameCXHL2101473 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/09/15New drug · Class 1 | SBK001注射液 · No verified English nameCXHL2101472 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/09/14Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101109 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/09/14Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101177 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/14Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101176 | Seagen Inc.; MSD R&D (China) Co. Ltd. |
| 2021/09/14Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2101730 | Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/09/14Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2101729 | Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/09/14Generic · Class 3 | Milrinone InjectionCYHS2101728 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/09/14Generic · Class 3 | 二氟泼尼酯滴眼液 · No verified English nameCYHS2101727 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2021/09/14Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2101719 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2021/09/14New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2101029 | Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized |
| 2021/09/14New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2101028 | Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TQB2868注射液 · No verified English nameCXSL2101325 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101479 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101478 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101477 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101476 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101475 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/14New drug · Class 1 | TY-302胶囊 · No verified English nameCXHL2101474 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2021/09/13Import · Class 1 | IcoSema 注射液 · No verified English nameJXSL2101108 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
29 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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