YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 284 drug applications between 22 July 2023 and 28 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 48 drug names.
2023/07/22 – 2023/07/28
- New acceptances this week
- 284
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- 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
284filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 142 |
| Generic | 57 |
| New drug | 45 |
| Import | 30 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 183 |
| Therapeutic biologic | 54 |
| TCM | 41 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 2 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 3 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 4 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 5 | Carfilzomib For Injection | 2 | 1 | 0 |
| 6 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 7 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 9 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 10 | Acetylcysteine Injection | 1 | 1 | 53 |
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
162 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Guizhou Tian Di Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Bayer AG | 9 | 2 | 0 |
| 4 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 7 | 2 | 0 |
| 5 | Sanofi Winthrop Industrie | 5 | 1 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 4 | 2 |
| 7 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shaanxi Feng Wu Chen Da Yao Tang Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液 · No verified English nameJXSS2300065 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液 · No verified English nameJXSS2300064 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300144 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300143 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300142 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 2.4 | ABL001片 · No verified English nameJXHL2300179 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/07/28Import · Class 2.4 | ABL001片 · No verified English nameJXHL2300178 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/07/28Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2302024 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Diprophylline InjectionCYHS2302021 | Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Jin Feng Pharmaceutical Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2302016 | Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2302014 | Jiangsu Chen Pai Pharma Group Co., Ltd. romanized; Jiangsu Han Chen Pharma Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Salbutamol Sulfate injectionCYHS2302013 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2302012 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2023/07/28Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2302011 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2023/07/28New drug · Class 1 | 注射用CMD011 · No verified English nameCXSL2300524 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2023/07/28New drug · Class 1 | CEFFE001注射剂 · No verified English nameCXSL2300523 | Shanghai Sa Mei Xi Bao Technology Co., Ltd. romanized |
| 2023/07/28New drug · Class 2.2 | 阿哌沙班口崩片 · No verified English nameCXHL2300826 | Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized |
| 2023/07/28New drug · Class 1 | MBT-1608片 · No verified English nameCXHL2300825 | Beijing SL Pharmaceutical Co., Ltd. |
| 2023/07/28New drug · Class 1 | BW-20805 注射液 · No verified English nameCXHL2300824 | Hangzhou Bo Lin Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/28New drug · Class 2.2 | JW2202吸入粉雾剂 · No verified English nameCXHL2300823 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/07/28New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2300822 | Le Pu Pharma Co., Ltd. romanized |
| 2023/07/28New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2300821 | Le Pu Pharma Co., Ltd. romanized |
| 2023/07/27Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2300141 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/27Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2300140 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/07/27Generic · Class 3 | Ursodeoxycholic acid oral suspensionCYHS2302006 | Name not romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300522 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300521 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300520 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 1 | 皮肤试验用结核分枝杆菌抗原(EM) · No verified English nameCXSL2300519 | An Bo Zhi Lian (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/07/27New drug · Class 3.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300518 | Jiangsu Rui Ke Bio Technology Co., Ltd. romanized; Beijing An Bai Sheng Bio Technology Co., Ltd. romanized |
67 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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