YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 207 drug applications between 31 July 2021 and 6 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 24 drug names.
2021/07/31 – 2021/08/06
- New acceptances this week
- 207
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- Accepted this week, now under review
- 1
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
207filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| New drug | 44 |
| Generic | 34 |
| Import re-registration | 16 |
| Import | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 127 |
| TCM | 41 |
| Therapeutic biologic | 37 |
| In vitro diagnostic reagent | 1 |
| Prophylactic biologic | 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Carbamazepine Extended-release Tablets | 3 | 1 | 0 |
| 2 | Alanyl Glutamine Injection | 2 | 1 | 4 |
| 3 | Enoxaparin Sodium Injection | 2 | 1 | 16 |
| 4 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 5 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 6 | Trimetazidine Dihydrochloride Tablets | 2 | 1 | 0 |
| 7 | Fosphenytoin Sodium Injection | 2 | 1 | 5 |
| 8 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 9 | Febuxostat Tablets | 2 | 1 | 12 |
| 10 | Ezetimibe Tablets | 1 | 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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized | 20 | 20 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 5 | 0 |
| 3 | Shaanxi An Yuan Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Eli Lilly and Company | 6 | 1 | 0 |
| 5 | Fresenius Kabi Deutschland GmbH | 6 | 1 | 0 |
| 6 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 3 | 2 | 1 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Lilly France | 3 | 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/05Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2101089 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2021/08/05Import · Class 1 | GT90001C注射液 · No verified English nameJXSL2101088 | Kintor Pharmaceuticals Hong Kong Limited; Suzhou Kintor Pharmaceticals Inc. |
| 2021/08/05Import · Class 2.2 | 注射用Loncastuximab tesirine · No verified English nameJXSL2101087 | ADC Therapeutics SA; Overland Pharmaceuticals (Shanghai) Co. Ltd. |
| 2021/08/05Import · Class 1 | QM1114 · No verified English nameJXSL2101084 | IPSEN Biopharm Limited; Q-Med International Trading (Shanghai) Co. Ltd |
| 2021/08/05Import · Class 1 | NNC0480-0389注射液 · No verified English nameJXHL2101150 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2021/08/05Generic · Class 3 | Tranexamic Acid InjectionCYHS2101531 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/08/05Generic · Class 3 | Tranexamic Acid InjectionCYHS2101530 | Hubei Shen Zhou Hua Rui Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/08/05Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2101527 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2021/08/05Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2101526 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2021/08/05Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2101523 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/08/05New drug · Class 1 | 派安普利单抗注射液 · No verified English nameCXSS2101020 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/05New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2101019 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2021/08/05New drug · Class 1 | GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2101240 | Shanghai Ji Bei Bio Technology Co., Ltd. romanized |
| 2021/08/05New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101239 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/05New drug · Class 1 | 注射用LM-302 · No verified English nameCXSL2101238 | Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2021/08/05New drug · Class 1 | 重组全人源抗RANKL单克隆抗体注射液 · No verified English nameCXSL2101237 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/08/05New drug · Class 2.2 | RHYK2001 · No verified English nameCXHL2101367 | Ren He Yi Kang Group Co., Ltd. romanized |
| 2021/08/03Import · Class 2.2 | DS-8201a · No verified English nameJXSL2101086 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/03Import · Class 1 | BI 905711输注用粉末 · No verified English nameJXSL2101085 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/03Import · Class 1 | NIS793 · No verified English nameJXSL2101079 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2021/08/03Import · Class 1 | AR882胶囊 · No verified English nameJXHL2101149 | Arthrosi Therapeutics INC; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/08/03Import · Class 1 | Elinzanetant 软胶囊 · No verified English nameJXHL2101148 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2021/08/03Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHS2101521 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101519 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101518 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbamazepine Extended-release TabletsCYHS2101517 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2101510 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2101509 | Kang Pu Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Calcitriol Oral SolutionCYHS2101503 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2021/08/03Generic · Class 3 | Famciclovir TabletsCYHS2101501 | Di Sha Pharma Group Co., Ltd. romanized |
38 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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