YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 298 drug applications between 5 July 2023 and 11 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 49 drug names.
2023/07/05 – 2023/07/11
- New acceptances this week
- 298
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- 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
298filings, 67 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 67 |
| New drug | 47 |
| Import | 13 |
| Unspecified | 12 |
| Import re-registration | 9 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 29 |
| Therapeutic biologic | 26 |
| Prophylactic biologic | 4 |
| 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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 2 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Dienogest Tablets | 2 | 2 | 2 |
| 5 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 6 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 7 | Methocarbamol Injection | 2 | 2 | 3 |
| 8 | Tadalafil Tablets | 2 | 1 | 23 |
| 9 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 10 | 复方奥美拉唑干混悬剂 · No verified English name | 2 | 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
185 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 17 | 4 | 0 |
| 2 | Hainan Brilliant Pharmaceutical Co., Ltd. | 15 | 3 | 0 |
| 3 | AstraZeneca AB | 7 | 4 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 6 | United States Pharmacopeial Convention | 3 | 3 | 0 |
| 7 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 3 | 3 | 3 |
| 8 | Fujian Sheng Quan Zhou Ya Tai Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Aerovate Therapeutics Inc. | 3 | 1 | 0 |
| 10 | Pfizer Inc. | 3 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/11Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300056 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2023/07/11Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300055 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2023/07/11Import · Class 2.2 | Tezepelumab注射液 · No verified English nameJXSL2300127 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2023/07/11Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2301865 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Potassium Phosphates InjectionCYHS2301864 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301863 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Lang Ou Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2301862 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Lang Ou Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2301861 | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2301860 | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2301853 | Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2301852 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2023/07/11Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2301850 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2023/07/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300051 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/11New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300050 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | 注射用SHR-5495 · No verified English nameCXSL2300462 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | SCM-181注射液 · No verified English nameCXSL2300461 | Yunnan Shun Xi Zai Sheng Yi Xue Gong Cheng Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | DXC006 · No verified English nameCXSL2300460 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2023/07/11New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2300459 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2300763 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | ABSK-011胶囊 · No verified English nameCXHL2300762 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/11New drug · Class 1 | NTQ1062片 · No verified English nameCXHL2300761 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/07/11New drug · Class 1 | NTQ1062片 · No verified English nameCXHL2300760 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/07/10Generic · Class 3 | 复方奥美拉唑干混悬剂 · No verified English nameCYHS2301849 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/07/10Generic · Class 3 | 复方奥美拉唑干混悬剂 · No verified English nameCYHS2301848 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/07/08Import · Class 3.1 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSS2300054 | argenx BV; Patheon Italia S.p.A.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/07/08Import · Class 1 | MBG453 · No verified English nameJXSL2300126 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/07/08Generic · Class 3 | Eptazocine Hydrobromide InjectionCYHS2301841 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2023/07/08Generic · Class 3 | Nimodipine Oral SolutionCYHS2301838 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/07/08Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2300082 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/07/08New drug · Class 1 | 注射用SIBP-A13 · No verified English nameCXSL2300458 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
55 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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