YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 377 drug applications between 5 August 2025 and 11 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 107, covering 75 drug names.
2025/08/05 – 2025/08/11
- New acceptances this week
- 377
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 107
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
377filings, 107 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 107 |
| New drug | 77 |
| Import | 16 |
| Import re-registration | 15 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 78 |
| Therapeutic biologic | 63 |
| Prophylactic biologic | 2 |
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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 3 | Acetylcysteine Injection | 3 | 3 | 53 |
| 4 | Finerenone Tablets | 3 | 2 | 69 |
| 5 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 6 | Levetiracetam Tablets | 3 | 1 | 6 |
| 7 | Lactulose Oral Solution | 2 | 1 | 34 |
| 8 | Tacrolimus Ointment | 2 | 1 | 6 |
| 9 | Piracetam Injection | 2 | 1 | 9 |
| 10 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shen Yao He Ze Pharma (Shandong) Co., Ltd. romanized | 15 | 6 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 10 | 6 | 0 |
| 3 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 9 | 8 | 0 |
| 5 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 7 | 5 | 6 |
| 6 | Bayer Inc. | 6 | 1 | 0 |
| 7 | Guizhou Hao Cheng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Hua Run Zi Zhu Pharma Co., Ltd. romanized | 5 | 4 | 2 |
| 10 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 5 | 4 | 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
126 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/11Import · Class 1 | Icotrokinra片 · No verified English nameJXHL2500213 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/08/11Import · Class 2.4; 2.2 | 马立巴韦干混悬剂 · No verified English nameJXHL2500212 | Takeda Pharmaceuticals U.S.A. Inc; Takeda(China) International Company Ltd. |
| 2025/08/11Import · Class 2.4; 2.2 | 马立巴韦干混悬剂 · No verified English nameJXHL2500211 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International Company Ltd. |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500094 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500093 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/11New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500092 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Glycopyrrolate InjectionCYHS2502894 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Glycopyrrolate InjectionCYHS2502893 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Elagolix Sodium TabletsCYHS2502892 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/08/09Generic · Class 3 | Elagolix Sodium TabletsCYHS2502891 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/08/09Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2502890 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500139 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2025/08/09Generic · Class 3 | Pregabalin Extended release TabletsCYHL2500138 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/08/09Generic · Class 3 | Pregabalin Extended release TabletsCYHL2500137 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/08/09New drug · Class 3.3 | 西妥昔单抗注射液 · No verified English nameCXSS2500081 | Guangdong An Pu Ze Biopharmaceuticals Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2025/08/09New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2500080 | 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 |
| 2025/08/09New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2500079 | 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 |
| 2025/08/09New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2500689 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2500688 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2500687 | Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2500686 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用SHR-9839 (sc) · No verified English nameCXSL2500685 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2500684 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500683 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500682 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500681 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | 注射用BL-M24D1 · No verified English nameCXSL2500680 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | QX029N注射液 · No verified English nameCXSL2500679 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500832 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/09New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500831 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
96 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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