YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 348 drug applications between 27 August 2023 and 2 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 93, covering 67 drug names.
2023/08/27 – 2023/09/02
- New acceptances this week
- 348
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
348filings, 93 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| Generic | 93 |
| New drug | 54 |
| Import | 13 |
| Import re-registration | 3 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 69 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 1 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 4 | 2 | 23 |
| 2 | Nicorandil for Injection | 3 | 2 | 1 |
| 3 | Etoricoxib Tablets | 3 | 1 | 8 |
| 4 | Quetiapine Fumarate Tablets | 3 | 1 | 0 |
| 5 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 6 | Potassium Chloride Injection | 2 | 2 | 10 |
| 7 | Lornoxicam for Injection | 2 | 2 | 2 |
| 8 | Moxifloxacin Hydrochloride Tablets | 2 | 2 | 11 |
| 9 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 10 | Phloroglucinol 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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 19 | 15 | 0 |
| 2 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 18 | 18 | 0 |
| 3 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | Pfizer Europe MA EEIG | 5 | 2 | 0 |
| 6 | AstraZeneca AB | 4 | 3 | 0 |
| 7 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 8 | Hainan Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 1 |
| 9 | Rui Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Organon Pharma (UK) Limited | 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/02Generic · Class 3 | Potassium Chloride InjectionCYHS2302366 | Hainan Ou Ruo La Bio Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Indobufen TabletsCYHS2302365 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Indobufen TabletsCYHS2302364 | Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Famotidine InjectionCYHS2302358 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2023/09/02Generic · Class 3 | Cisplatin InjectionCYHS2302357 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2023/09/02New drug · Class 2.1 | 清喉咽含片 · No verified English nameCXZS2300018 | Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized; Suzhou Wu Song Jiang Pharmaceutical Co., Ltd. romanized |
| 2023/09/02New drug · Class 1.2 | 洋常春藤叶口服液 · No verified English nameCXZL2300058 | Zhejiang Kang En Bei Zhong Yao Co., Ltd. romanized |
| 2023/09/02New drug · Class 1.2 | 洋常春藤叶提取物 · No verified English nameCXZL2300057 | Zhejiang Kang En Bei Zhong Yao Co., Ltd. romanized |
| 2023/09/02New drug · Class 3.4 | 人凝血因子IX · No verified English nameCXSL2300595 | Hua Lan Bio Gong Cheng Co., Ltd. romanized |
| 2023/09/02New drug · Class 2.2 | 大流行流感全病毒灭活疫苗(H5N1) · No verified English nameCXSL2300594 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized |
| 2023/09/02New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2300593 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2023/09/02New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2300592 | Guangdong Dan Xia Biopharmaceutical Co., Ltd. romanized |
| 2023/09/02New drug · Class 1 | 177Lu-LNC1003 注射液 · No verified English nameCXHL2300945 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2023/09/02New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2300944 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2023/09/02New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2300943 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized |
| 2023/09/02New drug · Class 1 | YR001软膏 · No verified English nameCXHL2300942 | Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/02New drug · Class 1 | YR001软膏 · No verified English nameCXHL2300941 | Hangzhou Yi Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/01Import · Class 1 | BI 765049 输注用粉末 · No verified English nameJXSL2300162 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/01Import · Class 1 | AUP1602-C · No verified English nameJXSL2300161 | Aurealis Therapeutics AG; Shenzhen Xbiome Biotech Co. Ltd. |
| 2023/09/01Import · Class 2.2 | Anifrolumab注射液 · No verified English nameJXSL2300160 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/09/01Generic · Class 3 | Bumetanide InjectionCYHS2302349 | Name not romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/09/01Generic · Class 3 | Potassium Chloride InjectionCYHS2302346 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/09/01Generic · Class 3 | Salbutamol Sulfate injectionCYHS2302342 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/09/01Generic · Class 3 | Revefenacin inhalation solutionCYHL2300111 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2023/09/01New drug · Class 1 | 注射用RC108 · No verified English nameCXSL2300591 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/09/01New drug · Class 1 | HB0025注射液 · No verified English nameCXSL2300590 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/01New drug · Class 1 | HB0025注射液 · No verified English nameCXSL2300589 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/01New drug · Class 2.2 | 布地奈德福莫特罗吸入粉雾剂(胶囊型) · No verified English nameCXHL2300939 | Zhuhai Rui Si Pu Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/01New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2300938 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/01New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2300937 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
65 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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