YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 346 drug applications between 25 August 2023 and 31 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 65 drug names.
2023/08/25 – 2023/08/31
- New acceptances this week
- 346
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 1
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
346filings, 83 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 83 |
| New drug | 50 |
| Import | 14 |
| Unspecified | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 67 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 6 |
| 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
65 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 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 4 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | Enzalutamide Tablets | 2 | 1 | 2 |
| 7 | Potassium Chloride Injection | 2 | 1 | 10 |
| 8 | Risperidone powder and solvent for depot suspension for Injection | 2 | 1 | 0 |
| 9 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 10 | 注射用头孢唑肟钠 · No verified English name | 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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 32 | 28 | 0 |
| 2 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 23 | 23 | 0 |
| 3 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Novartis Europharm Limited | 6 | 3 | 0 |
| 5 | Celgene Corporation | 6 | 1 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 7 | Sanofi-Aventis Deutschland GmbH | 5 | 5 | 0 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 9 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Shaanxi Kang Na Duo Pharma Co., Ltd. romanized | 3 | 3 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/31Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2300074 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2023/08/31Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2300073 | UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd |
| 2023/08/31Generic · Class 3 | Enzalutamide TabletsCYHS2302339 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/08/31Generic · Class 3 | Enzalutamide TabletsCYHS2302338 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2023/08/31Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2302337 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Zhejiang Qian Yuan Hai Li Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | Epalrestat TabletsCYHS2302333 | Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302332 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302331 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | Potassium Chloride GranulesCYHS2302326 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | Nicorandil for InjectionCYHS2302325 | Hefei Sheng Qin Pharmaceuticals Technology Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2023/08/31Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2302323 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2023/08/31New drug · Class 1.1 | 麻星宣肺止咳贴 · No verified English nameCXZL2300056 | Hubei You Er Sheng Pharma Co., Ltd. romanized |
| 2023/08/31New drug · Class 1.1 | 麻星宣肺止咳贴 · No verified English nameCXZL2300055 | Hubei You Er Sheng Pharma Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | 注射用重组溶瘤病毒M1 · No verified English nameCXSL2300588 | Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | SRSD101注射液 · No verified English nameCXHL2300932 | Jing Yin Pharma (Shanghai) Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | OQL036 · No verified English nameCXHL2300931 | Shanghai An Kuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | OQL036 · No verified English nameCXHL2300930 | Shanghai An Kuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | ASK120067片 · No verified English nameCXHL2300929 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2023/08/31New drug · Class 2.4 | 康替唑胺片 · No verified English nameCXHL2300928 | Shanghai Meng Ke Pharma Co., Ltd. romanized |
| 2023/08/31New drug · Class 1 | 注射用MRX-4 · No verified English nameCXHL2300927 | Shanghai Meng Ke Pharma Co., Ltd. romanized |
| 2023/08/30Import · Class 1 | PF-06940434注射液 · No verified English nameJXSL2300159 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2023/08/30Generic · Class 3 | 盐酸丙卡特罗片 · No verified English nameCYHS2302320 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2023/08/30Generic · Class 3 | Pentoxifylline InjectionCYHS2302319 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2302310 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302308 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302307 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Mesalamine extended release capsulesCYHS2302305 | Beijing Foyou Pharma CO.,LTD |
| 2023/08/30Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302304 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2302302 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2302299 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
66 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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