YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 273 drug applications between 27 June 2021 and 3 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 41, covering 31 drug names.
2021/06/27 – 2021/07/03
- New acceptances this week
- 273
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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
273filings, 41 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 41 |
| New drug | 41 |
| Import | 23 |
| Unspecified | 12 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 170 |
| TCM | 55 |
| Therapeutic biologic | 43 |
| Prophylactic biologic | 5 |
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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 2 | 23 |
| 2 | Compound Ipratropium Bromide Solution For Inhalation | 2 | 2 | 4 |
| 3 | Clindamycin Injection | 2 | 1 | 4 |
| 4 | Ornidazole Injection | 2 | 1 | 0 |
| 5 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 6 | Lidocaine Hydrochloride Injection | 2 | 1 | 6 |
| 7 | Ropivacaine hydrochloride injection | 2 | 1 | 5 |
| 8 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 9 | Desmopressin Acetate Injection | 2 | 1 | 0 |
| 10 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 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
145 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized | 37 | 34 | 0 |
| 2 | Guizhou Liang Ji Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 3 | Roche Pharma (Schweiz) Ltd. | 6 | 1 | 0 |
| 4 | AstraZeneca AB | 5 | 3 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 5 | 2 | 0 |
| 6 | Mao Xiang Group Jilin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Merck Sharp & Dohme Corp. | 4 | 2 | 0 |
| 8 | Pliva Croatia Ltd. | 4 | 2 | 0 |
| 9 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 3 | 3 | 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
77 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/02Import · Class 3.1 | 莫格利珠单抗注射液 · No verified English nameJXSS2101015 | Kyowa Kirin Co. Ltd.; Toyobo Company Limited Otsu Pharmaceutical Plant |
| 2021/07/02Import · Class 2.2 | DS-8201a · No verified English nameJXSL2101064 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/07/02Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101063 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/07/02Import · Class 1 | RO7247669注射液 · No verified English nameJXSL2101059 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd |
| 2021/07/02Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2101380 | Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/07/02Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2101379 | Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/07/02New drug · Class 1.2 | 广金钱草总黄酮胶囊 · No verified English nameCXZS2101003 | Wuhan Guang Gu Ren Fu Biopharmaceuticals Co., Ltd. romanized; Wuhan Kang Le Pharma Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | EP-9001A注射液 · No verified English nameCXSL2101166 | Chengdu You Luo Bio Technology Co., Ltd. romanized |
| 2021/07/02New drug · Class 2.2 | 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHL2101258 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | AK3280乳膏 · No verified English nameCXHL2101257 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | AK3280乳膏 · No verified English nameCXHL2101256 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | AK3280乳膏 · No verified English nameCXHL2101255 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/02New drug · Class 2.2 | 泊沙康唑干混悬剂 · No verified English nameCXHL2101254 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2021/07/02New drug · Class 1 | AN0025片 · No verified English nameCXHL2101247 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/01Import · Class 1 | MK-1308A注射液 · No verified English nameJXSL2101062 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/07/01Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSL2101061 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/07/01Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSL2101060 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/07/01Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2101376 | Shenzhen Li Jian Pharma Co., Ltd. romanized |
| 2021/07/01Generic · Class 3 | Aripiprazole Oral SolutionCYHS2101372 | Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2021/07/01Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2101369 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2021/07/01New drug · Class 3.4 | 人凝血因子Ⅷ · No verified English nameCXSS2101006 | Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized |
| 2021/07/01New drug · Class 3.3 | 注射用人高血糖素 · No verified English nameCXSL2101165 | Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized |
| 2021/07/01New drug · Class 2.4 | Remimazolam Besylate For InjectionCXHS2101026 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101250 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101249 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/07/01New drug · Class 1 | HTMC0503片 · No verified English nameCXHL2101248 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/06/30Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSS2101014 | Roche Registration GmbH; Roche Diagnostics GmbH; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | RO7030816 · No verified English nameJXSL2101058 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | RO7030816 · No verified English nameJXSL2101057 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/06/30Import · Class 1 | avalglucosidase alfa for injection · No verified English nameJXSL2101056 | Sanofi-aventis Recherche & Développement; Sanofi (China) investment Co. Ltd |
47 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.