YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 325 drug applications between 8 July 2021 and 14 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 27 drug names.
2021/07/08 – 2021/07/14
- New acceptances this week
- 325
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
325filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 206 |
| New drug | 55 |
| Generic | 36 |
| Import | 24 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| Therapeutic biologic | 46 |
| TCM | 45 |
| In vitro diagnostic reagent | 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ceftriaxone Sodium for Injection | 3 | 1 | 9 |
| 2 | Acetylcysteine Granules | 2 | 2 | 4 |
| 3 | Tacrolimus Ointment | 2 | 2 | 6 |
| 4 | Ceftazidime for Injection | 2 | 1 | 4 |
| 5 | Epinastine Hydrochloride Granules | 2 | 1 | 0 |
| 6 | Minoxidil Topical Solution | 2 | 1 | 0 |
| 7 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 8 | Cisatracurium Besylate Injection | 2 | 1 | 4 |
| 9 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液 · No verified English name | 1 | 1 | 0 |
| 10 | Sodium Valproate Concentrated Solution for Injection | 1 | 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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 42 | 28 | 0 |
| 2 | Yang Zi Jiang Pharma Group Jiangsu Long Feng Tang Zhong Yao Co., Ltd. romanized | 19 | 18 | 0 |
| 3 | Novartis Pharma Schweiz AG | 13 | 4 | 0 |
| 4 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 5 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Guangxi Gu Fang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 8 | AstraZeneca AB | 5 | 2 | 0 |
| 9 | Eli Lilly and Company | 5 | 2 | 0 |
| 10 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 5 | 2 | 5 |
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 |
|---|---|---|
| 2021/07/14Import · Class 3.1 | 那昔妥单抗注射液 · No verified English nameJXSS2101016 | Y-mAbs Therapeutics Inc.; Patheon Manufacturing Services LLC; SciClone Pharmaceuticals (China) Co. Ltd. |
| 2021/07/14New drug · Class 3.4 | 门冬胰岛素30注射液 · No verified English nameCXSS2101012 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2021/07/14New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSS2101011 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2021/07/14New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101195 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/07/14New drug · Class 1 | 注射用LBL-024 · No verified English nameCXSL2101194 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/07/14New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2101193 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/14New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2101192 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/14New drug · Class 1 | 重组人源化抗白介素-6受体单克隆抗体注射液 · No verified English nameCXSL2101184 | Beijing Wei De Jie Bio Technology Co., Ltd. romanized |
| 2021/07/14New drug · Class 1 | SYHA1402片 · No verified English nameCXHL2101292 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/07/14New drug · Class 2.1 | 硫酸黏菌素E2颗粒 · No verified English nameCXHL2101291 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/07/14New drug · Class 1 | W1302片 · No verified English nameCXHL2101290 | Zhongguo Yi Xue Ke College Drug Research Institute romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2021/07/14New drug · Class 1 | 注射用RBOA · No verified English nameCXHL2101289 | Guangzhou Shi Rui Bo Bio Technology Co., Ltd. romanized |
| 2021/07/13Generic · Class 3 | Vincriscristine Sulfate InjectionCYHS2101434 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2021/07/13Generic · Class 3 | Epinastine Hydrochloride GranulesCYHS2101419 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2021/07/13Generic · Class 3 | Epinastine Hydrochloride GranulesCYHS2101418 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2021/07/13Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂（II） · No verified English nameCYHL2101019 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2021/07/13New drug · Class 3.4 | 门冬胰岛素50注射液 · No verified English nameCXSS2101010 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2021/07/13New drug · Class 1 | 派安普利单抗注射液 · No verified English nameCXSS2101007 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/13New drug · Class 1 | 注射用DNV3 · No verified English nameCXSL2101190 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2021/07/13New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHS2101029 | Bei Da Pharma Co., Ltd. romanized |
| 2021/07/13New drug · Class 2.4 | 盐酸恩沙替尼胶囊 · No verified English nameCXHS2101028 | Bei Da Pharma Co., Ltd. romanized |
| 2021/07/13New drug · Class 1 | IMP5471-CA胶囊 · No verified English nameCXHL2101288 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2021/07/12Import · Class 1 | Mobocertinib胶囊 · No verified English nameJXHS2101024 | Takeda Pharmaceuticals U.S.A. Inc.; Xcelience LLC; Takeda (China) International Trading Co. Ltd |
| 2021/07/12Generic · Class 3 | Olmesartan Medoxomil and Amlodipine Besylate TabletsCYHS2101433 | An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized |
| 2021/07/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101428 | Yangtze River Pharmaceutical Group Co., Ltd; Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | PM8001注射液 · No verified English nameCXSL2101188 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101187 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | IBI389 · No verified English nameCXSL2101186 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | IBI322 · No verified English nameCXSL2101183 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/07/12New drug · Class 3.3 | 注射用重组抗IgE人源化单克隆抗体 · No verified English nameCXSL2101178 | Shanghai Tai Yin 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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