YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 342 drug applications between 26 August 2023 and 1 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 62 drug names.
2023/08/26 – 2023/09/01
- New acceptances this week
- 342
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- 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
342filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 82 |
| New drug | 49 |
| Import | 13 |
| Unspecified | 8 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| TCM | 74 |
| Therapeutic biologic | 35 |
| Prophylactic biologic | 5 |
| 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
62 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 | Potassium Chloride Injection | 3 | 2 | 10 |
| 3 | Nicorandil for Injection | 3 | 2 | 1 |
| 4 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 5 | Lornoxicam for Injection | 2 | 2 | 2 |
| 6 | Moxifloxacin Hydrochloride Tablets | 2 | 2 | 11 |
| 7 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 8 | Tacrolimus Ointment | 2 | 1 | 6 |
| 9 | Enzalutamide Tablets | 2 | 1 | 2 |
| 10 | Risperidone powder and solvent for depot suspension for Injection | 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
199 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 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Novartis Europharm Limited | 6 | 3 | 0 |
| 5 | Celgene Corporation | 6 | 1 | 0 |
| 6 | Sanofi-Aventis Deutschland GmbH | 5 | 5 | 0 |
| 7 | Merck Sharp & Dohme LLC | 4 | 2 | 0 |
| 8 | Hainan Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 1 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 4 | 1 | 0 |
| 10 | AstraZeneca AB | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/09/01New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2300936 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/01New drug · Class 1 | GS3-007a干混悬剂 · No verified English nameCXHL2300935 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/01New drug · Class 2.4 | Neratinib Maleate TabletsCXHL2300934 | Fu Kang (Shanghai) Health Technology Co., Ltd. romanized; Zhejiang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2023/09/01New drug · Class 1 | HZ-Q1070胶囊 · No verified English nameCXHL2300933 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Huan Bo Hai (Yan Tai) Drug Gao Deng Research Institute romanized |
| 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 |
59 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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