YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 300 drug applications between 26 March 2025 and 1 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 51 drug names.
2025/03/26 – 2025/04/01
- New acceptances this week
- 300
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 20
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
300filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 75 |
| New drug | 49 |
| Import | 18 |
| Import re-registration | 4 |
| Unspecified | 1 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 206 |
| TCM | 47 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 3 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 2 | Upadacitinib Sustained-release Tablets | 3 | 1 | 43 |
| 3 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Ferrous Succinate Tablets | 2 | 2 | 20 |
| 7 | Sodium Nitroprusside Injection | 2 | 2 | 15 |
| 8 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 9 | Apalutamide Tablets | 2 | 2 | 18 |
| 10 | Calcitriol Injection | 2 | 2 | 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
182 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 8 | 5 | 0 |
| 3 | Eli Lilly and Company | 7 | 2 | 0 |
| 4 | Novo Nordisk A/S | 6 | 1 | 0 |
| 5 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hunan Jiudian Pharmaceutical Co., Ltd | 4 | 4 | 1 |
| 8 | Jin He Zang Yao Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Amgen Inc. | 4 | 2 | 0 |
| 10 | Henan Pu Rui Pharma Co., Ltd. romanized | 4 | 2 | 4 |
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 |
|---|---|---|
| 2025/04/01Generic · Class 3 | Famciclovir TabletsCYHS2501240 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized |
| 2025/04/01Generic · Class 3 | Famciclovir TabletsCYHS2501239 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized |
| 2025/04/01Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2501237 | Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2025/04/01Generic · Class 3 | Haloperidol Oral SolutionCYHS2501233 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | 注射用SHR-A1904 · No verified English nameCXSL2500258 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500257 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500256 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2500255 | Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2500254 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2500253 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | SHR2554片 · No verified English nameCXHL2500347 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | SNH-119014片 · No verified English nameCXHL2500346 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | SNH-119014片 · No verified English nameCXHL2500345 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2025/04/01New drug · Class 1 | SNH-119014片 · No verified English nameCXHL2500344 | Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized |
| 2025/03/31New drug · Class 1 | 爱可仑赛注射液 · No verified English nameCXSS2500039 | Beijing Yong Tai Bio Zhi Pin Co., Ltd. romanized |
| 2025/03/29Generic · Class 3 | Trimebutine Maleate TabletsCYHS2501232 | Zhejiang Dong Ya Pharma Co., Ltd. romanized |
| 2025/03/29Generic · Class 3 | Trimebutine Maleate TabletsCYHS2501231 | Zhejiang Dong Ya Pharma Co., Ltd. romanized |
| 2025/03/29Generic · Class 3 | 厄贝沙坦氨氯地平片(III) · No verified English nameCYHS2501230 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2025/03/29Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2501229 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/03/29Generic · Class 3 | 厄贝沙坦氨氯地平片(I) · No verified English nameCYHS2501228 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. |
| 2025/03/29Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501227 | Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/03/29Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2501226 | Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/03/29New drug · Class 2.2 | AKZ002直服颗粒 · No verified English nameCXHL2500343 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2025/03/28Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500038 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/28Import · Class 3.1 | 度伐利尤单抗注射液 · No verified English nameJXSS2500037 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/03/28Import · Class 1 | Empasiprubart注射用浓溶液 · No verified English nameJXSL2500047 | argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd. |
| 2025/03/28Import · Class 1 | PF-07985045片 · No verified English nameJXHL2500066 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/03/28Import · Class 1 | PF-07985045片 · No verified English nameJXHL2500065 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500064 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/03/28Import · Class 1 | Orforglipron胶囊 · No verified English nameJXHL2500063 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
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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