YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 351 drug applications between 15 November 2023 and 21 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 59 drug names.
2023/11/15 – 2023/11/21
- New acceptances this week
- 351
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 4
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
351filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 79 |
| New drug | 44 |
| Import | 21 |
| Unspecified | 12 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| TCM | 63 |
| Therapeutic biologic | 31 |
| Biologic | 7 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brivaracetam Tablets | 4 | 1 | 19 |
| 2 | Famotidine Injection | 3 | 2 | 8 |
| 3 | Dabigatran Etexilate Capsules | 3 | 1 | 2 |
| 4 | Levodopa and Benserazide Hydrochloride Tablets | 2 | 2 | 2 |
| 5 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 6 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 7 | Gabapentin Capsules | 2 | 1 | 0 |
| 8 | Perindopril arginine and amlodipine besylate tablets | 2 | 1 | 3 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Neostigmine Methylsulfate 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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | AstraZeneca AB | 9 | 4 | 0 |
| 3 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 1 | 0 |
| 4 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 2 | 5 |
| 7 | Eli Lilly and Company | 5 | 1 | 0 |
| 8 | Novo Nordisk A/S | 5 | 1 | 0 |
| 9 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Pfizer Europe MA EEIG | 4 | 2 | 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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/21Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2303200 | Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303190 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Famotidine InjectionCYHS2303189 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303184 | Guangdong Sai Kang Pharmaceutical Factory Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Magnesium Sulfate InjectionCYHS2303181 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Drotaverine Hydrochloride TabletsCYHS2303180 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2023/11/21Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2303179 | An Sheng Pharma Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized |
| 2023/11/21Generic · Class 3 | Brivaracetam TabletsCYHL2300143 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/11/21Generic · Class 3 | Brivaracetam TabletsCYHL2300142 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/11/21Generic · Class 3 | Brivaracetam TabletsCYHL2300141 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/11/21Generic · Class 3 | Brivaracetam TabletsCYHL2300140 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/11/21New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHS2300103 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/11/21New drug · Class 1 | FCN-437c胶囊 · No verified English nameCXHS2300102 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/11/21New drug · Class 1 | 177Lu-NYM032注射液 · No verified English nameCXHL2301288 | Wuxi Nuo Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/21New drug · Class 1 | KX-826酊 · No verified English nameCXHL2301287 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2023/11/21New drug · Class 1 | KX-826酊 · No verified English nameCXHL2301286 | Suzhou Kai Tuo Pharma Co., Ltd. romanized |
| 2023/11/21New drug · Class 2.2 | OPL-058迟释片 · No verified English nameCXHL2301285 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2023/11/20Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2300292 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/20Import · Class 1 | AZD3470薄膜衣片 · No verified English nameJXHL2300291 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/11/20Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2303177 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/11/20Generic · Class 3 | Acetate And Glucose Electrolytes InjectionCYHS2303176 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/11/20Generic · Class 3 | Pregabalin Oral SolutionCYHS2303172 | Beijing Suo Pu Xing Da Pharmaceuticals Research Co., Ltd. romanized; Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized |
| 2023/11/20Generic · Class 3 | Fexofenadine Hydrochloride Oral SuspensionCYHS2303171 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/11/20New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2300023 | Hainan Kang Mao Xin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group De Zhong (Fo Shan) Pharma Co., Ltd. romanized |
| 2023/11/20New drug · Class 1.1 | 四仙颗粒 · No verified English nameCXZL2300071 | Sichuan Sheng Zhong Pharmaceuticals Ke College romanized |
| 2023/11/20New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300794 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/11/20New drug · Class 1 | TQB2223 注射液 · No verified English nameCXSL2300793 | Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized |
| 2023/11/20New drug · Class 1 | IMC001注射液 · No verified English nameCXSL2300792 | Chengdu Yi Mu Feng Bio Technology Co., Ltd. romanized; Suzhou Yi Mu Feng Bio Technology Co., Ltd. romanized |
| 2023/11/20New drug · Class 2.4 | 镥[177Lu]氧奥曲肽注射液 · No verified English nameCXHL2301284 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/18Generic · Class 3 | Arbidol Hydrochloride TabletsCYHS2303169 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
58 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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