YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 144 drug applications between 1 February 2025 and 7 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 48 drug names.
2025/02/01 – 2025/02/07
- New acceptances this week
- 144
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 8
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
144filings, 64 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 64 |
| Supplement | 46 |
| New drug | 18 |
| Import re-registration | 11 |
| Import | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 119 |
| TCM | 12 |
| Therapeutic biologic | 12 |
| Prophylactic 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 | Vonoprazan Fumarate Tablets | 7 | 4 | 60 |
| 2 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 3 | Cetrorelix Acetate for Injection | 2 | 2 | 4 |
| 4 | Voglibose Tablets | 2 | 1 | 0 |
| 5 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | Imatinib Mesylate Tablets | 2 | 1 | 5 |
| 8 | Labetalol Hydrochloride Tablets | 2 | 1 | 3 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Norepinephrine Bitartrate Injection | 2 | 1 | 9 |
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
106 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 2 | Wuhan Jiu An Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 3 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 3 | 2 | 3 |
| 4 | Neurelis Inc. | 3 | 1 | 0 |
| 5 | Nipro Pharma Corporation | 3 | 1 | 0 |
| 6 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 1 | 0 |
| 7 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 3 | 1 | 3 |
| 8 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | DAIICHI SANKYO CO. LTD. | 2 | 2 | 0 |
| 10 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized | 2 | 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
46 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/07Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2500020 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/02/07Import · Class 1 | ALXN2030注射液 · No verified English nameJXHL2500017 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/02/07Generic · Class 3 | Methotrexate TabletsCYHS2500619 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2500618 | Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2500612 | Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2500607 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2500606 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2500605 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Minoxidil LinimentCYHS2500598 | Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Minoxidil LinimentCYHS2500597 | Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2500595 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2500594 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2500593 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Potassium Chloride InjectionCYHS2500588 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2500586 | Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Labetalol Hydrochloride TabletsCYHS2500583 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Labetalol Hydrochloride TabletsCYHS2500582 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2025/02/07Generic · Class 3 | Esflurbiprofen PatchesCYHL2500032 | Qilu Pharmaceutical Co., Ltd. |
| 2025/02/07New drug · Class 1 | 注射用KH815 · No verified English nameCXSL2500104 | Chengdu Kang Hong Bio Technology Co., Ltd. romanized |
| 2025/02/07New drug · Class 1 | 注射用BL-M09D1 · No verified English nameCXSL2500103 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/07New drug · Class 2.2 | 卡度尼利单抗注射液 · No verified English nameCXSL2500102 | Kang Fang Pharma Co., Ltd. romanized |
| 2025/02/07New drug · Class 2.2 | YHAX · No verified English nameCXHL2500158 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2025/02/07New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500157 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/02/07New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500156 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/02/07New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500155 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/02/07New drug · Class 2.4 | TAP-1503 乳膏 · No verified English nameCXHL2500154 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/06Import · Class 1 | [225Ac]Ac-PSMA-617注射液 · No verified English nameJXHL2500015 | Novartis Pharma AG |
| 2025/02/06Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2500579 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2500578 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/02/06Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500576 | Lang Tian Pharma (Hubei) Co., Ltd. romanized |
16 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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