YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 271 drug applications between 6 July 2021 and 12 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 26 drug names.
2021/07/06 – 2021/07/12
- New acceptances this week
- 271
- 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
271filings, 37 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| New drug | 43 |
| Generic | 37 |
| Import | 30 |
| Import re-registration | 4 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 35 |
| Therapeutic biologic | 26 |
| In vitro diagnostic reagent | 2 |
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 | Ceftriaxone Sodium for Injection | 3 | 1 | 9 |
| 2 | Acetylcysteine Granules | 2 | 2 | 4 |
| 3 | Tacrolimus Ointment | 2 | 2 | 6 |
| 4 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 5 | Levetiracetam Tablets | 2 | 1 | 6 |
| 6 | Ceftazidime for Injection | 2 | 1 | 4 |
| 7 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 8 | Minoxidil Topical Solution | 2 | 1 | 0 |
| 9 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 10 | Cisatracurium Besylate Injection | 2 | 1 | 4 |
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
135 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 | 17 | 16 | 0 |
| 3 | AstraZeneca AB | 8 | 3 | 0 |
| 4 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 5 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Guangxi Gu Fang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 5 | 2 | 5 |
| 8 | Fo Shan De Rui Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Novartis Europharm Ltd. | 4 | 2 | 0 |
| 10 | McNeil Sweden AB | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/07/12New drug · Class 2.2 | HR19024注射液 · No verified English nameCXHL2101287 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | ST-1703片 · No verified English nameCXHL2101286 | Beijing Sai Te Ming Qiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | ST-1703片 · No verified English nameCXHL2101285 | Beijing Sai Te Ming Qiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101284 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101283 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/07/12New drug · Class 2.2 | 来那度胺缓释片 · No verified English nameCXHL2101282 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 2.2 | 来那度胺缓释片 · No verified English nameCXHL2101281 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2101280 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/12New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2101279 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/09Import · Class 2.4 | Copanlisib 注射用冻干制剂 · No verified English nameJXHS2101025 | Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/09Import · Class 2.4 | Trametinib TabletsJXHL2101131 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | Trametinib TabletsJXHL2101130 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHL2101129 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHL2101128 | Novartis Europharm Ltd.; Beijing Novartis Pharmaceutical Co. Ltd. |
| 2021/07/09Import · Class 1 | BAY 2586116鼻喷雾剂 · No verified English nameJXHL2101127 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/07/09Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2101425 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2021/07/09Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液 · No verified English nameCYHL2101018 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/07/09New drug · Class 1 | C-4-29细胞制剂 · No verified English nameCXSL2101182 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2021/07/09New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101177 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/09New drug · Class 1 | TNP-2092胶囊 · No verified English nameCXHL2101278 | Dan Nuo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/07/09New drug · Class 2.2 | 阿哌沙班多释片 · No verified English nameCXHL2101277 | Tai Zhou Yue Yang Pharmaceuticals Kai Fa Co., Ltd. romanized |
| 2021/07/09New drug · Class 1 | HMPL-453酒石酸盐片 · No verified English nameCXHL2101276 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
46 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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