YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 345 drug applications between 13 September 2025 and 19 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 69 drug names.
2025/09/13 – 2025/09/19
- New acceptances this week
- 345
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 112
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
345filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 87 |
| New drug | 49 |
| Import | 27 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| Therapeutic biologic | 83 |
| TCM | 75 |
| Prophylactic biologic | 8 |
| Biologic | 5 |
| In vitro diagnostic reagent | 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Buspirone Hydrochloride Tablets | 3 | 1 | 5 |
| 2 | Lidocaine and Tetracaine Cream | 2 | 2 | 2 |
| 3 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 4 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 5 | Levocarnitine Injection | 2 | 1 | 4 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 2 | 1 | 10 |
| 7 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 8 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
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
203 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Si Huan Biopharmaceutical Co., Ltd. romanized | 10 | 1 | 0 |
| 2 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 3 | 0 |
| 3 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Gansu Fu Zheng Pharma Technology Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | AstraZeneca AB | 7 | 5 | 0 |
| 6 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 7 | 2 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Novartis Pharma AG | 5 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/19Import · Class 1 | 注射用AZD0292 · No verified English nameJXSL2500182 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd |
| 2025/09/19Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2503469 | Guangzhou Ju Li Pharmaceuticals Kai Fa Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2025/09/19Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2503467 | Hubei Mei Lin Pharma Co., Ltd. romanized |
| 2025/09/19Generic · Class 3 | Lidocaine and Tetracaine CreamCYHS2503466 | Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized |
| 2025/09/19Generic · Class 3 | Vitamin K1 InjectionCYHS2503464 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2025/09/19New drug · Class 1.1 | 参苏止咳颗粒 · No verified English nameCXZL2500083 | Yu Sen (Jiangxi) Xin Yao Research and Development Co., Ltd. romanized |
| 2025/09/19New drug · Class 3.3 | 阿柏西普眼内注射溶液 · No verified English nameCXSS2500098 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized; Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/19New drug · Class 1 | 泰卡西单抗注射液 · No verified English nameCXSS2500097 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized |
| 2025/09/19New drug · Class 1 | 泰卡西单抗注射液 · No verified English nameCXSS2500096 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized |
| 2025/09/19New drug · Class 1 | 注射用SSGJ-709 · No verified English nameCXSL2500806 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/09/19New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗 · No verified English nameCXSL2500805 | Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2025/09/19New drug · Class 1.2 | 冻干带状疱疹病毒mRNA疫苗 · No verified English nameCXSL2500804 | Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2025/09/19New drug · Class 2.2 | 注射用苏维西塔单抗 · No verified English nameCXSL2500803 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2025/09/19New drug · Class 1 | HLX37注射液 · No verified English nameCXSL2500802 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/19New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501018 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/09/19New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501017 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/09/19New drug · Class 1 | TQF3250胶囊 · No verified English nameCXHL2501016 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/09/18Import · Class 1 | CVM-1118胶囊 · No verified English nameJXHL2500294 | TaiRx Inc.; TaiRx Pharmaceutical (Kunshan). Ltd. |
| 2025/09/18Import · Class 2.2; 2.4 | 双醋瑞因软膏 · No verified English nameJXHL2500293 | TWi Biotechnology Inc.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2025/09/18Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2503457 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2503453 | Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2503451 | Yan Tai Ju Xian Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2503450 | Yan Tai Ju Xian Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Trihexyphenidyl Hydrochloride TabletsCYHS2503445 | Yun Peng Pharmaceuticals Group Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2503444 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500170 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/09/18Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2500169 | Fu Yuan Pharma Co., Ltd. romanized |
| 2025/09/18New drug · Class 3.1 | 半夏白术天麻颗粒 · No verified English nameCXZS2500040 | Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized |
| 2025/09/18New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2500039 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized |
| 2025/09/18New drug · Class 2 | 人细小病毒B19核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2500095 | Beijing Wan Tai Bio Pharma Co., Ltd. romanized |
72 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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