YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 269 drug applications between 4 June 2023 and 10 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 53 drug names.
2023/06/04 – 2023/06/10
- New acceptances this week
- 269
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- 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
269filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 109 |
| Generic | 78 |
| New drug | 51 |
| Import | 13 |
| Unspecified | 11 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| Therapeutic biologic | 40 |
| TCM | 26 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Injection | 3 | 3 | 10 |
| 2 | Minoxidil Topical Solution | 3 | 2 | 0 |
| 3 | Lactulose Oral Solution | 3 | 1 | 34 |
| 4 | 注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name | 3 | 1 | 2 |
| 5 | Neostigmine Methylsulfate Injection | 3 | 1 | 4 |
| 6 | Nitroglycerin Sublingual Tablets | 3 | 1 | 3 |
| 7 | 预充式甲氨蝶呤注射液 · No verified English name | 3 | 1 | 0 |
| 8 | Phloroglucinol Injection | 2 | 2 | 2 |
| 9 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
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
171 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized | 6 | 1 | 0 |
| 2 | Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | YaoPharma Co., Ltd. | 4 | 2 | 1 |
| 4 | Xin Dong Sheng Ji Co., Ltd. romanized | 4 | 1 | 0 |
| 5 | Hua Run Shuang He Pharma Co., Ltd. romanized | 3 | 3 | 1 |
| 6 | Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Guangxi Tai Nuo Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | AstraZeneca AB | 3 | 2 | 0 |
| 9 | Merck Healthcare KGaA | 3 | 2 | 0 |
| 10 | Jiangsu En Hua Pharma Co., Ltd. romanized | 3 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301598 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301597 | Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Potassium Chloride InjectionCYHS2301596 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Perospirone Hydrochloride TabletsCYHS2301594 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Perospirone Hydrochloride TabletsCYHS2301593 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Nitroglycerin InjectionCYHS2301592 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Nitroglycerin InjectionCYHS2301591 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2301590 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/06/10Generic · Class 3 | Potassium Chloride GranulesCYHS2301588 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Potassium Chloride GranulesCYHS2301587 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/06/10Generic · Class 3 | Bumetanide InjectionCYHS2301586 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2023/06/10Generic · Class 3 | Nicergoline TabletsCYHS2301585 | Beijing Jiu Neng Tian Yuan Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2023/06/10New drug · Class 1 | TAVO412注射液 · No verified English nameCXSL2300408 | Tuo Chuang Bio Technology (Jiangsu) Co., Ltd. romanized |
| 2023/06/10New drug · Class 1.2 | 人用狂犬病mRNA疫苗 · No verified English nameCXSL2300407 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | SGN1注射液 · No verified English nameCXSL2300406 | Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | SGN1注射液 · No verified English nameCXSL2300405 | Guangzhou Hua Jin Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | SM17单克隆抗体注射液 · No verified English nameCXSL2300404 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | ZX-7101A片 · No verified English nameCXHL2300636 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | ZX-7101A片 · No verified English nameCXHL2300635 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2023/06/10New drug · Class 2.4; 2.1 | ASC10片 · No verified English nameCXHL2300634 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | HRS-7450注射液 · No verified English nameCXHL2300633 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | PG-011凝胶(Ⅱ) · No verified English nameCXHL2300632 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | PG-011凝胶(Ⅱ) · No verified English nameCXHL2300631 | Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | ISM4808胶囊 · No verified English nameCXHL2300630 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | ISM4808胶囊 · No verified English nameCXHL2300629 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2023/06/10New drug · Class 2.3 | HMK-JST-080 · No verified English nameCXHL2300628 | Zhejiang He Mu Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | APL-1401胶囊 · No verified English nameCXHL2300627 | Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/10New drug · Class 1 | APL-1401胶囊 · No verified English nameCXHL2300626 | Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/09New drug · Class 2.2 | 注射用替奈普酶 · No verified English nameCXSL2300403 | Shanghai Feng Hua Tian Li Tong Biopharmaceuticals Co., Ltd. romanized |
| 2023/06/09New drug · Class 1 | 硫酸艾玛昔替尼片 · No verified English nameCXHS2300052 | Rui Shi Biopharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
62 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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