YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 31 August 2023 and 6 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 61 drug names.
2023/08/31 – 2023/09/06
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- 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
323filings, 85 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 85 |
| New drug | 56 |
| Import | 15 |
| Import re-registration | 7 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 237 |
| TCM | 55 |
| Therapeutic biologic | 26 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Phloroglucinol Injection | 4 | 4 | 2 |
| 2 | Nicorandil for Injection | 3 | 2 | 1 |
| 3 | Etoricoxib Tablets | 3 | 1 | 8 |
| 4 | Quetiapine Fumarate Tablets | 3 | 1 | 0 |
| 5 | Tadalafil Tablets | 2 | 2 | 23 |
| 6 | Nicorandil Tablets | 2 | 2 | 4 |
| 7 | Bumetanide Injection | 2 | 2 | 13 |
| 8 | Potassium Chloride Injection | 2 | 2 | 10 |
| 9 | Lornoxicam for Injection | 2 | 2 | 2 |
| 10 | Metaraminol Tartrate Injection | 2 | 2 | 2 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | CISEN PHARMACEUTICAL CO., LTD. | 5 | 2 | 1 |
| 6 | Shenyang Hong Yao Group Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 9 | Rui Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | LianBio Development (SG) Pte. Ltd. | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/06Import · Class 1 | AMG 133 · No verified English nameJXSL2300163 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2023/09/06Generic · Class 3 | Bumetanide InjectionCYHS2302402 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2302400 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Nicorandil for InjectionCYHS2302399 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Nicorandil for InjectionCYHS2302398 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Levocarnitine TabletsCYHS2302397 | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302395 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Mercaptopurine TabletsCYHS2302394 | Zhejiang Cheng Yi Pharma Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2302389 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/09/06Generic · Class 3 | Trelagliptin Succinate TabletsCYHL2300114 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/09/06New drug · Class 3.3 | Sabin株脊髓灰质炎灭活疫苗(Vero细胞) · No verified English nameCXSS2300073 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/09/06New drug · Class 2.2 | BCM857口溶膜 · No verified English nameCXHL2300962 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2023/09/06New drug · Class 2.2 | BCM857口溶膜 · No verified English nameCXHL2300961 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | NH103草酸盐片 · No verified English nameCXHL2300960 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | NH103草酸盐片 · No verified English nameCXHL2300959 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | NH103草酸盐片 · No verified English nameCXHL2300958 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | NH103草酸盐片 · No verified English nameCXHL2300957 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2300956 | Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized |
| 2023/09/06New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2300955 | Zhi Wei Biopharmaceuticals (Xin Xiang) Co., Ltd. romanized |
| 2023/09/05Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300076 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd. |
| 2023/09/05Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300075 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland; MSD R&D (China) Co. Ltd. |
| 2023/09/05Import · Class 1 | JDQ443片 · No verified English nameJXHL2300202 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2023/09/05Import · Class 1 | DMX-200 · No verified English nameJXHL2300201 | Dimerix Bioscience Pty Ltd; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/09/05Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302386 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Amoxicillin Sodium for InjectionCYHS2302385 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302378 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2302377 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2302376 | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized |
| 2023/09/05Generic · Class 3 | 美洛昔康纳米晶注射液 · No verified English nameCYHL2300112 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2023/09/05New drug · Class 1.1 | 藿夏感冒颗粒 · No verified English nameCXZL2300059 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
70 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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